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Pharma Bio World
INTERVIEW 08
“India’s rapidly growing capability is likely to position it as a leading player in Biosimilars” - Debayan Ghosh, President & Founder, Epygen Biotech
FEATURES 16
Emerging Trends and Challenges in Vaccine Development and Manufacturing
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Closed-System Connections in Monoclonal Antibodies R&D for Cancer - Todd Andrews
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Pharma Bio World
interview
Debayan Ghosh
“India’s rapidly growing capability is likely to position it as a leading player in Biosimilars”
8 October 2017
Debayan Ghosh Co-founded and built Epygen in the year 2006 with a vision to emerge as a leading biotech innovator enhancing human life. Epygen’s current focus area is to produce and launch Biosimilar Recombinant Streptokinase (rSK) for the cardiovascular segment under License and Technology support from CSIR Govt of India. In an interview with Mahesh Kallayil, Mr Ghosh talks about biosimilar market in India, their process of completing the Regulatory Pathway of cardiovascular Thrombolytic Recombinant Protein drug for patients in Indian subcontinent and the underprivileged of the world and his aim to produce this LifeSaving drug to address the mid income strata and bottom of the pyramid. Can you tell us about company’s journey till date? Epygen group was conceived nearly a decade back outside India, in Dubai Science Park and Colorado USA, by two persons of Indian origin, me and my long time friend Ariyarathenam. Our connecting thread was Biocon. While I was one of the first Biotech graduates in India who went on work for Biocon as a campus recruit, Ariyarathenam was running an agency for Biocon in south Asian countries for several years. After 5 years in Biocon and 7 years working for a US Biotechnology company based in south Florida, I started Epygen in 2006. Ariyarathenam soon joined in, and a few years later, his son Ineeyan, a business graduate from the King’s college of London, joined the team. We started Epygen in India with the funds that we earned from our Biotech ventures abroad, as a 100% FDI setup. With our several years of experience of Fermentation, Protein expression and purification, we decided to focus completely on Biopharmaceuticals development and manufacturing in India and chose recombinant Streptokinase, a cardiovascular thrombolytic protein, as our entry product toBiosimilars. We quickly tied up with CSIR-IMTECH in Chandigarh India to license in its Recombinant Streptokinase technology, from lab scale technology transfer to scaling up and expression of proteins up to pre clinical and clinical scales.
Under the able guidance of the then director of CSIRIMTECH, who was also and the leader of Streptokinase research in the world, we went on cracking the puzzles of a newer version of streptokinase. Our aim was to make it safer for patients, produced it more efficiently and also utilize our skills in process optimization and protein engineering to enhance the expression levels, making this critical life saving protein more affordable to the masses in India and the region. Department of Biotechnology agency BIRAC acknowledged our efforts to improve this technology for the unmet needs in India, where 15 Lakh people dye of heart attack every year. They extended financial assistance for our research, injecting a big boost to our enthusiasm and purpose. We went on to construct a state of art Recombinant Biotech and Protein Purification lab in Navi Mumbai, employing top Biotech scientists experienced in USA and India, whose the focus was to imbibe the technology that was being transferred and continue further development and fine tune. Subsequently, we started the work to construct a 60,000 square feet Biopharmaceutical facility in Patalganga, Maharashtra, to expand our research activity by several folds and further produce these Biosimilar proteins in commercial scales. Epygen’s recombinant Pharma Bio World
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interview proteins are in regulatory stages of Pre-clinical Trials with the recombinant Streptokinase to be launched by 2019 and an exciting pipeline of other e-coli based technologies e.g PEG GCSF (a Chemo Induced Neutropenia protein drug) and Monoclonal Antibodies for Oncology, making steady progress.
across the globe, especially in Asia, African and Latin American countries, each of which market Epygen is going to target. Our pipeline products like GCSF, PEG GCSF, Recombinant Hormones and Monoclonal Antibodies project billions of dollars biosimilar market in the regulated and semi-regulated markets.
How is the company positioned in the Indian and global market?
How does the company keep abreast with the ever-changing trends in biopharmaceutical market?
Let me talk about our stepping stone protein Recombinant Streptokinase. Epygen is amongst very few companies in the world to produce Recombinant Streptokinase, the only affordable thrombolytic injection for STEMI (ST Elevated Myocardial infarction patients). Amongst Cardiovascular disease patients and number of people suffering strokes in urban and rural part of India, at least 0.5% of Indian population is at risk of suffering from myocardial infarction Cardiac stroke. This gives a potential of 6.0 million cases of thrombolytic treatment in India. Though for urban patients with higher economic capabilities, the top preferences would be tPA, 60% of urban population and nearly 100% of the rural population would be potential candidates for streptokinase treatment in our country. From the market figure on number of vials sold per year by the major brands, the current usage covers a miniscule portion of the potential. This indicates a huge influx of undocumented and spurious/unreliable thrombolytics being used in the country. Streptokinase is by far the most economic Thrombolytic agent available, costing approximately Rs. 2,000-3,500 for a full dose of 1.5 million units. Mainly because of its cost, it remains the most used agent in clinical practice in the country. In addition, the recombinant version is free from streptolysin/ streptodornase associated with natural Streptokinasem making it safer for use. tPA based innovator drugs on the other hand, are the most expensive agents available for this treatment segment, costing approximately Rs 40,000 per full dose. Another available tPA Biosimilar agent in India costs approximately Rs 25,000 per dose. This comparison shows that for a cost sensitive Indian market, affordability still remains a limiting factor for most of these Thrombolytic agents except for Streptokinase. Streptokinase is widely used as a first line of treatment for STEMI patients 10 ď‚ƒ October 2017
Epygen engages continuously in conducting market intelligence exercise employing agencies like IMS etc., in addition to its Biotech network worldwide, which provides access to all the exciting scientific and commercial developments in the field of Biopharmaceuticals. We participate in global conferences, where we often contribute scholastically and our scientists are encouraged to continuously update their outlook through such events. How do you see the biopharma market in India maturing? The Indian biotech market seems to have doubled in size in the past few years! This is expected, since it was very negligible to start with. The industry grew by a whooping 30%, fueled by the rise in domestic business, exports, mergers and acquisitions and new product innovations. Over the past five years, the industry has reportedly grown steadily by a 30 % to 50 %. The sector at present, employs more than 30,000 Biotech scientists, who continue to drive growth. Even then, the Indian market currently accounts for a little over 1.1 % of the global biotech market. However, its rapidly growing capability is likely to position it as a leading player in the years to come, especially in the area of Biosimilars, posing a triple digit growth in the next decade. India already ranks third in Asia-Pacific, after Japan and Korea and among the top 12 globally. The Central Drugs Standard Control Organization and the Department of Biotechnology constantly monitors and improves biosimilar drugs policy and regulatory pathway, for manufacturing processes that aims to deliver safety, efficacy and quality of international standards. This policy is expected to catapult the Indian biosimilars market size to the vicinity of US$50 billion by 2030!
How do you place India among the Asia-Pacific countries? Do you feel that India could be an important player in biopharmaceuticals? At first glance, Asia undoubtedly appears to be an assured avenue of growth for pharmaceutical manufacturers on the whole. According to IMS Market Prognosis 2012, the pharmaceutical market in Asia is expected to reach USD 350 billion in 2016-17, comprising 30% of the global pharmaceutical market of USD 1.2 trillion and driving close to 50% of global, incremental growth. Taking a closer look at the top pharmaceuticals locatedin Asia-Pacific reconfirms the importance of China, Japan, and India whose companies make up 32.0 %, 42.0 %, and 14.0 % in terms of market capitalization by regional companies respectively. In addition, India pharma is expected to grow over 15 % per annum between 2015 and 2020, and outperform the global pharma industry benchmark. The market is expected to grow to USD 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. With a clear perspective that 75% of pipeline drugs globally are from Biopharmaceutical nature, and 8 out of 10 largest selling drugs in 2017 being from Biopharmaceutical basket, a total of 667 innovative biopharmaceuticals were launched in the U.S. over the past 20 years, bringing new treatment options to critical ailments. From a numerical perspective and anticipating the progress of drug candidates currently in the research and development pipeline, the state of biopharmaceutical innovation is robust. The source of the biopharmaceutical innovation that is successfully launched in the U.S. is highly diverse, with over 300 entities filing original patents to protect the intellectual property that became the basis for the 667 medicines that were launched. Biologic agents will continue to outpace overall pharma spending growth and are expected to represent 19-20% of the total market value by 2017. The Asia Pacific biopharma market has exploded since the 1990s, with thousands of homegrown biopharma companies and major multinationals setting up shop across the region. Pharma Bio World
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interview Can you explain more about Epygen’s Biotech incubation facility at Navi Mumbai? Epygen’s incubation facility in Navi Mumbai is equipped with the state of art equipment for Recombinant Technology work, Fermentation, Protein Expression and Purification with a full fledged DSP line up. It can develop and express recombinant proteins based on a wide range of expression hosts and scale up process based on an array of molecular biology, protein engineering and bioprocess optimization techniques. It houses a strong team of scientists with experience in the United States and India specializing in the area of Bioprocess, Regulatory and Quality Assurance, apart from the core team of Molecular Biologists. It is equipped to express proteins of interest at various levels, model, monitor and scale up manufacturing of these critical therapeutic proteins based on the needs of Indian patients. Could you please elucidate more on Epygen’s Pegfilgrastim and Bevacizumab? As stated earlier, 8 out of top 10 highest selling drugs in the world come from biotech origin, contributing sales of nearly $65 billion. While the worldwide sales of Bevacizumab and Pegfilgrastim contributes 7.2 Billion and 4.8 Billion USD respectively, sales of Bevacizumab and Pegfilgrastim from India are only INR 98 Cr and INR 84 Cr respectively, owing to the price barrier presented by the innovator. Harnessing the tools of Proteomics and improved bioprocess, which Epygen had been consistently able to do for several years, we are aiming to bring about a sea change in these meager numbers, rendering these drugs more affordable for patients in the region. With the highest quality standards that Epygen practices for therapeutic proteins, we are aiming to cater to the semi regulated markets world wide with these Biosimilar drugs and bring about some parity with the global numbers. What do you see as the big drivers of innovation occurring in Cardiovascular therapy and oncology drugs right now? There has been an increase in the prevalence of cancer and heart disease as the population ages.Cardiovascular disease (CVD) and cancer 12 October 2017
are the 2 leading causes of death worldwide. Modern treatment strategies have led to improvement in the chances of surviving a diagnosis of cancer; however, these treatments are expensive. Heart disease is the numberone cause of death in the US and in most high-income countries, followed by cancer, and for years deaths from both diseases have been on the decline.. A quick survey at new drug approvals over 2010 and the first half of 2011 shows that the cardiovascular sphere got just three new medications: Dabigatran etexilate (Pradaxa, Boehringer Ingelheim), Azilsartan medoxomil (Edarbi, Takeda Pharmaceutical), and ticagrelor (Brilinta, AstraZeneca). By contrast, 13 new drugs have been approved since January 2010 for different cancers. Drugs still in development paint an even starker picture: while cancer has over 700 drugs in development, the number of cardiovascular drugs in the pipeline is just 147. As a biosimilar manufacturer, how you think the industry should balance between protecting the rights of a patent holder and providing affordable health care for all? The issue of intellectual property and in particular patents is a matter of debate. The issue holds more significance with respect to pharmaceutical patents and the concerned stakeholders which has resulted in a fierce policy debate regarding patenting across the globe and especially in developing countries. It is widely believed that patients in developing countries are disadvantaged as newer medicines under patent are out of reach of millions either due to lack of access or due to exorbitant costs. The recent issue of compulsory license in India for Bayer’s anti-cancer drug Nexavar (SorefenibTosylate), ¬¬¬¬unveiled a host of issues. Since, multinational pharmaceutical companies may fear to introduce newer medical therapies in Indian market, it is important to repose their faith in the system so that new medicines are launched in India. Various measures such as monitoring of prices of patented medicines, negotiating the price of a patented medicine by the government before marketing, providing petty patents (utility patents) for minor innovations, procurement of patented medicines by government for public distribution,
encouraging healthcare insurance, fostering Industry-Institute partnerships etc. may help balance access to affordable medicines and incentive for innovators. Can we have your take on patent cliff and its implications in generic market? To avoid falling off the cliff, innovators often augment their patents by process patenting or somehow extend market exclusivity for their products utilizing some IP extension tools. for a One frequently used strategy is to procureadditional patents beyond the original patents that protect the drug’s primary active ingredient and disease targets. A key question is to what level these later-issued patents protect valid features or methods, instead of serving as a business strategy to delay generic competition, simply as a barrier to progress. In some cases, the patent claim may be frail or largely duplicative of an already patented feature or product. These patents can amplify the cost for a manufacturer to bring a generic version of a drug to market and in effect delay approval of the generic drug after the patents on the underlying base compound expire. It is well established that extending market exclusivity by extending or augmenting patents can have severe public health implications in our part of the world. Please brief us on generic drug patent and FDA issues? The average time for FDA approval has increased to nearly 8 years in recent times. There is a huge risk of economic burden due to such lengthy regulatory time for Biopharma companies. If the drug shows unpromising or average results in its clinical trial, then this leads to low or unpredictable sales and companies have no way to recover the cost invested on that molecule. In addition, intellectual property has made the market penetration even more difficult for Biosimilar drugs. In the case of drugs where the patent has been extended for an additional five years, it has been impossible for Biosimilar drugs to get in at a lower price point. The anatomy of an exorbitant cost of drug development is primarily related to government policies, FDA long-approval and time-consuming complex trials, that the Biopharma faces. Pharma Bio World
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Emerging Trends and Challenges in Vaccine Development and Manufacturing
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accines are the most promising approach of developing preventive therapeutics strategies in order to alleviate the worldwide load of communicable diseases [1]. The preventive mechanism of current available vaccines can be explained by the ability to stimulate the antibodies which can neutralize the infectious etiological agents upon natural infection. In 1983, 99 per cent reduction in measles cases has been achieved in United States using Measles vaccine [2]. Similarly, a great achievement has been attained in case of Polio, Tetanus and smallpox through effective vaccination strategy [3].
Vaccine can be broadly classified into various categories such as Live attenuated; Inactivated; Subunit; Toxoid; Conjugated; DNA and Recombinant vector vaccine [4]. Antigenicity of a vaccine can be enhanced by using an adjuvant which can be described as substances used in combination with specific antigens eventually results in robust immune response. On the basis of its mechanism adjuvant can be broadly divided into delivery systems and immunestimulatory adjuvant. Various substances have been utilize as an adjuvant such as microbial products, mineral salts, saponins, polymers, emulsions, microparticles and liposome [5]. Generation of a live attenuated vaccine (LAV) can be achieved by attenuating the naturally existing viruses [6]. Unlike LAV, less immunogenic inactivated vaccines are generated by killing the etiological microbial agents with radiations, chemicals and heat [7]. Subunit vaccine can be developed by including only the immunogenic antigens with the advantage of lower adverse effects [8]. Toxoid vaccine is successful vaccination strategy exploited in case of bacterial infections secreting toxins [9]. Furthermore, conjugate vaccines are the special type of toxoid vaccine
targeting bacterial infections where a polysaccharide coating is used to disguise the bacterial antigens [10]. The relatively easy and inexpensive to design DNA vaccine are the most effective strategy used to stimulate strong immune response [11]. Recombinants vaccines are the DNA vaccines along with vectors such as virus or bacterium [12]. The developmental process of a vaccine can be broadly categorized into 2 stages; Preclinical and Clinical development. Preclinical development process includes Reverse vaccinology (identification of relevant antigens), creation of a vaccine concept, determination of effectiveness in animal models, and manufacturing of the vaccine under GLP facility. Whereas clinical development process include clinical trials in human subjects (Phase I-IV) [13]. Approximately, 50 licensed vaccines are available for human use and 50 per cent of them are prescribed widely. The arena of vaccines has long been neglected from a commercial perspective because of several factors including insufficient preclinical data, constant updating (antigenic variation) of vaccine formulations, adverse effects/ hypersensitivity, storage and preservation especially cold chain maintenance. Similarly, lacks of meaningful market motivation, reduced investments in vaccine R&D are the cost-benefit obstacles for the vaccine manufacturers. Challenges in Vaccine Development and Manufacturing The production of a successful vaccine for an infectious disease is the tip of an iceberg that comes after facing numerous challenges at different levels of vaccine development and manufacturing. The determination of potential target antigen, antigenicity, competent immune response, Pharma Bio World
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Figure1: Stages of Vaccine Development. Vaccine development comprises of 4 stages namely as Outbreak or Pandemic condition of the infectious diseases, Preclinical following clinical development and Manufacturing of vaccine. generation of antibodies, insufficient data from the pre-clinical trials, genetic variation of antigens [14], and in some special cases vaccines can cause antibody-dependent enhancement of infection [15] [16], are the challenges experienced during the generation of vaccines from the research perspective. Likewise, the industries involved in development and manufacturing of vaccines have to deal with the cost-benefit obstacles such as the long-term source of investment for vaccine production, urgent bulk productions in case of outbreaks and pandemics, storage and safety facilities. Some of these challenges are: 1. Lack of Motivated Market The requirement of vaccines has increased on a global scale due to rising number of cases of infectious diseases along with the genetic variation, assortment and evolution of infectious agents, despite 18 ď‚ƒ October 2017
the fact, only few leading pharmaceutical industries (such as Merck & Co. Inc., GlaxoSmithKline, Sanofi Pasteur, and Wyeth) have the facilities and strength to develop and manufacture new vaccines. To accommodate the rising demand, small industries such as Berna Biotech, Baxter, Chiron and Acambis have emerged for the development of new vaccines. The major challenges faced by the small industries is to develop a vaccine product in accordance with the stringent regulatory norms, as the safety and effectiveness of the vaccine are imperative, considering the fact that it has to be administered in healthy new-born babies, children, and adults unlike the drugs are given to individuals with disease. Moreover, the establishment of the complex state of the art technologies, expensive hightech facilities and apex level laboratories are required for taking the pilot-scale of vaccine generation to bulk preparation. The regulatory body assures that the quality of
every dose of vaccine-generated is with uniform efficacy and safety. Thus, with the support of leading health organizations and funding agencies, availability of vaccines could be rapid as several small industries will be willing to participate [17]. 2.Preparedness for Outbreaks and Pandemics The global alertness during outbreaks and pandemics has been improvised due to continuous monitoring of number of incidences of infectious diseases reported in the surveillance systems that provide authenticate data for estimating the severity of disease. Vaccines are the ultimate weapon to combat the outbreaks from turning to pandemics, however, the immediate requirement of new vaccine candidate for the emerging infectious agent becomes a cumbersome task for the pharmaceutical industries [18]. Pharma Bio World
well as the its biological activity to generate the immune response. Manufacturing of such large molecules require extensive analytical analysis and clinical testing by the regulatory bodies to reassure the equivalence of every batch of vaccine in terms of potency and safety. Bridging the Gap Between Vaccine Development and Challenges Associated with them
Figure 2: Vaccine development: challenges and implications. Challenges associated with vaccine developments are Outbreak and pandemic conditions, Lack of motivated market, Cost vs. Benefit ratio and how to bridge the gap to overcome them in order to develop an effective and safe vaccine. Collaboration between a research team comprising of scientists, bioprocess engineers, academicians and industries in short period of time is itself a difficult task for the preparation of safe and effective final vaccine product [19]. The development of a robust and practical vaccine requires a thorough research at both in vitro and in vivo levels, genome sequencing of the infectious agent, identification of the correct antigen for vaccine preparation in a limited period of time, and furthermore maintaining the consistency of vaccine obtained at in vivo stage to the final product. The pharmaceutical industries require a lucrative source of funding to facilitate themselves with advanced technologies for providing immediate and effective vaccine candidates which is another very crucial factor. 3. Cost-benefit vs. Risk-benefit The early stages of research for vaccine development require a huge investment, 20 ď‚ƒ October 2017
resulting abandonment of small scale industries in mid-way of discovering a potential vaccine candidate. Despite the fact of high cost of vaccine development, the benefit of patent protection on the new vaccine is for a limited period of time which leaves the pharmaceutical industries in dilemma of analyzing the cost-benefit ratio[20]. With the very low cost of vaccines in developing or low-income countries, the pharmaceutical companies are worried regarding their trafficking to the developed countries which will be a setback for their business. The risk associated with manufacturing of vaccine is at every step from characterization of the correct potential antigen candidate to the maintenance and precise performance of the concerned equipments. A wrong judgment or a misstep prone to error at any stage could ruin this time consuming and expensive process of vaccine development. Preparation of vaccine involves consideration of factors such as the molecular weight of the potent antigen which is 10,000 times greater than the size of the pharmaceutical drugs as
In current scenario, vaccines are not only targeting the emerging infectious diseases but also other spectrum of chronic infections, cancer, neurodegenerative diseases, and tumors. Besides, vaccine could be given at all ages and also to the impoverished populations living in developing countries to enhance their quality of life. The economic crisis has cut down the healthcare budget and left the policy makers and decision-making bodies in dilemma in order to understand/calculate the value of vaccines. One of the platforms for calculating the value of vaccination is Strategic Multi-Attribute Ranking Tool for Vaccines (SMART) developed by Institute of Medicine, for improvising the decision making for resolving various difficult attributes of vaccination[21]. With the advanced scientific approaches such as bioinformatics, genomic and proteomic studies, better understanding of the concerned disease could be conducted for rational designing of the vaccine. The discovery of vaccine from an early stage involves lucrative financial support from funding agencies to the pharmaceutical industries. The corporate social responsibility of eminent companies could be utilized by the healthcare officials for vaccine development during outbreaks of infectious diseases. All the essential components for the vaccine development such as antigens (active component), adjuvants, diluents, stabilizers, preservatives, trace components (egg proteins, yeast, antibiotics, research team, advanced instruments/technologies, regulatory body, bulk production facility should be enabled in an industry for rapid manufacture of new vaccines. Pharma Bio World
Conclusions and Future Perspectives
References:
Emerging new infectious diseases and antigenic variation among the circulating infectious agents have limited the prosperity of Antibody mediated protection, suggesting that we need to focus on various ways to develop advanced vaccines with robust efficacy and safety. In order to achieve, several approaches such as reverse vaccinology, adjuvant development, and vector design have provided an opportunity to the preclinical developmental process for a successful vaccine candidate formation. Lack of resources at the critical stages of the preclinical developmental process is indicating the urgency for the new funding, the most imperative factor in vaccine industry. Establishment of a Global vaccine development fund may accelerate the development of new and improved vaccines. Investment of USD 2 billion a year may cut down the global health risk and reduces the disease burden worldwide.
1. Haikerwal A, Bhatt MLB, Saxena SK. Reducing the Global Burden of Dengue: Steps toward Preventive Methods. Arch Prev Med. 2017; 2(1): 028-033. 2. Atkinson WL, Orenstein WA, Krugman S. The resurgence of measles in the United States, 1989-1990. Annu Rev Med. 1992; 43: 451-463. 3. Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, Lee BW, Lolekha S, Peltola H, Ruff TA, Santosham M, Schmitt HJ. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008; 86(2): 140-146. 4. Cherukommu, S, Swamy MLA, Saxena SK. Current scenario of vaccines for Japanese encephalitis. Am. J. Virol., 2014; 3(1): 1-5. (doi: 10.3844/ajvsp.2014.1.5) 5. Awate S, Babiuk LA, Mutwiri G. Mechanisms of action of adjuvants. Front Immunol. 2013; 4: 114. 6. Lauring AS, Jones JO, Andino R. Rationalizing the development of live attenuated virus vaccines. Nat Biotechnol. 2010; 28(6): 573-579 7. Wiesehahn GP, Creagan RP, Stevens DR, Giles R. Preparation of inactivated viral vaccines. US Patent US4693981 A, 15 Sept 1987. 8. Shinnick TM, Sutcliffe JG, Green N, Lerner RA. Synthetic peptide immunogens as vaccines. Annu Rev Microbiol. 1983; 37: 425-446. 9. Schmitt CK, Meysick KC, O’Brien AD. Bacterial toxins: friends or foes? Emerg Infect Dis. 1999; 5(2): 224-234. 10. Astronomo RD and Burton DR. Carbohydrate vaccines: developing sweet solutions to sticky situations? Nat Rev Drug Discov. 2010; 9(4): 308-324. 11. Kutzler MA and Weiner DB. DNA vaccines: ready for prime time? Nat Rev Genet. 2008; 9(10): 776-788. 12. Hansson M, Nygren PA, Ståhl S. Design and production of recombinant subunit vaccines. Biotechnol Appl Biochem. 2000; 32 (Pt 2): 95-107.
Acknowledgments The authors are grateful to the Vice Chancellor, King George’s Medical University (KGMU), Lucknow and Director, Centre for Cellular and Molecular Biology, Council of Scientific and Industrial Research (CSIR-CCMB), India for the encouragement and support for this work. S K Saxena is also supported by CCRH, Government of India, and US NIH grants: R37DA025576 and R01MH085259. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Conflict of Interest: None Abbreviations: Live attenuated vaccine (LAV), Strategic Multi-Attribute Ranking Tool for Vaccines (SMART). 22 October 2017
13. Delany I, Rappuoli R, De Gregorio E. Vaccines for the 21st century. EMBO Mol Med. 2014; 6(6): 708-720. 14. Saxena SK, Mishra N, Saxena R, Swamy MLA, Sahgal P, Saxena S, Tiwari S, Mathur A, Nair MP. Structural and antigenic variance between novel influenza A/H1N1/2009 and influenza A/H1N1/2008 viruses. J Infect Dev Ctries., North America 2010; 4(1): 1-6. 15. Haikerwal A, Kumar S, Kant R, Saxena SK. Potential therapeutics for dengue virus infection. Ann Pharmacol Pharm. 2017; 2(8): 1046. 16. Saxena SK, Haikerwal A, Gadugu S, Bhatt MLB. Complementary and alternative medicine in alliance with conventional medicine for dengue therapeutics and prevention. Future Virol. 2017 17. Buckland BC. The process development challenge for a new vaccine. Nat Med. 2005; 11(4 Suppl): S16-9. 18. Saxena SK, Elahi A, Gadugu S, Prasad AK. Zika virus outbreak: an overview of the experimental therapeutics and treatment. VirusDis. 2016; 27(2): 111115. doi: 10.1007/s13337-016-0307-y. 19. Sheerin D, Openshaw PJ, Pollard AJ. Issues in vaccinology: Present challenges and future directions. Eur J Immunol. 2017 2017. 0: 1-9. doi: 10.1002/eji.201746942. 20. Oyston P and Robinson K. The current challenges for vaccine development. J Med Microbiol. 2012; 61(Pt 7): 889894. 21. Rappuoli R, Pizza M, Del Giudice G, De Gregorio E. Vaccines, new opportunities for a new society. Proc Natl Acad Sci U S A. 2014 Aug 26; 111(34): 12288-12293.
Contact: shailen@kgmcindia.edu Pharma Bio World
Closed-System Connections in Monoclonal Antibodies R&D for Cancer
o n aar ioproci oba a i opm 24 October 2017
W
orld Health Organization reveals that the number of patients diagnosed with cancer is expected to see a global spike by over 70% in the next two decades. Specifically in India, this spike will result in a 25% increase in new cases by 2020, of which breast, lung and cervix cancers are the most prevalent causes of fatality. With greater government support from the region, the rising incidence of cancer as well as a variety of chronic diseases drove a steady demand in Asia Pacific for monoclonal antibodies – a biological therapy used to restore the immune systems of patients by targeting affected areas to destroy diseased cells. According to a recent study by Transparency Market Research, the global monoclonal antibodies therapeutics market is projected to worth over USD 245.8 billion by 2024, a huge growth from USD 86.7 billion in 2015. In order to effectively capture a share of this thriving market, researchers must attain quality findings to develop monoclonal antibodies in the most cost-efficient ways. However, researchers are constantly facing two critical forms of contamination during their daily lab tests which hinder their pursuit for quality findings: biological contamination and cross-contamination. Biological contamination includes competitive organisms such as bacteria, fungi and yeasts that are inadvertently introduced into cell culture processes. These organisms utilize culture nutrients, produce unwanted proteins and limit growth or destroy the intended cell culture. Most biological contaminations result in rapid growth and observable culture changes that indicate a culture must be discarded. However, slow growing contaminations can be subtle and may only become apparent when unwanted
proteins are detected. In either case, biological contaminations are costly both in wasted time and materials. Cross-contamination occurs when protein residues from cell culture and processing equipment is reused without proper sanitation. These residual proteins might inhibit proper cell growth or, if they are structurally and chemically similar to the target protein, they pass through purification with the target protein and yield inconsistent results. The systems and connectors used in R&D and process development of cell culture applications play a critical role in determining the efficacy of systems adopted to protect against both biological and crosscontamination. Creating the Environment
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Research
Traditionally, closed systems using tube welders or open systems using luer fittings are commonly used. However, they do not necessarily have the flexibility required of today’s research environment to allow onthe-fly changes during cell culture, even more so now with the rising demand for monoclonal antibodies therapeutics. Tube welders may work well for some R&D scale applications, but are expensive to purchase and maintain, and typically takes longer time to install. Additionally, they do not work with silicone tubing, and may experience difficulties operating in tight spaces. Breakthrough in sterile connections have made singleuse connectors designed for smallscale connections a great alternative to tube welders. They offer a robust construction, ensuring repeatable and reliable performance in the 1/8” to 1/4” ID connection range with no additional Pharma Bio World
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hardware required. For instance, the genderless AseptiQuik ® S is designed to offer a lightweight, cost-effective option for sterile connections which can withstand pressures in high vibration applications, giving an edge over tube welders that will rupture under the same conditions. Male-to-female connections like luer fittings and quick connects require more part numbers both at the component level and the finished good level. On the other hand, genderless connections simplify the supply chain ordering process and ensure that a connection can always be made at the user site. Issues of receiving single-use systems with incompatible types of connections (i.e. both have a male connector) can be eliminated with the use of a genderless connector. Moreover, connectors with multiple terminations such as 1/8”, 1/4” and 3/8” hose barbs, 3/4” sanitary and MPC quick connect insert are useful for adapting tubing sizes, connecting securely to filters and adapting quick connects to sterile connections. For instance, by using genderless connectors, several ports on a bioreactor can be used interchangeably for medium feed sampling or harvests. Additional sterile connections can be added to a bioreactor at any time through the addition of a manifold with several genderless connectors. Furthermore, sterile connectors allow connection to be done even in nuke corners, a flexibility that tube welders do not offer. Considerations in Implementing Genderless Single-use Connections While genderless interchangeability is a significant advantage, it is not the only feature to consider. Process engineers need to ensure that the connector has an overall functionality to deliver a reliable, repeatable and secure connection. Important connector attributes to consider are: • Ease of use – Connectors should be as intuitive to use as possible with a 26 October 2017
minimal number of actuation steps. The more actuation steps required in a connection, the higher the risk of operator error. Simpler is better. • Robustness – Connectors need to be able to withstand intended use as well as unintended abuse. One of the issues common with some connectors is the inability to withstand sideloading. Side-loading is difficult to avoid when dealing with tube and bag assemblies, so the connector you choose needs to be able to handle situations that are less than perfect. • Secondary equipment –, Connectors should not require additional equipment (such as tri-clover clamps, fixtures or assembly aids) to ensure a solid connection. If additional equipment is needed, this may indicate that the connector on its own is not as robust as you need. Another concern is that operators can fail to use components not integral to the connector, and these usage errors could make the connector non-functional. • Seal design – The seal design is your last line of defense against leaking or microbial ingress into the connector, so it is important to understand what is providing the final seal within the connector. When evaluating connectors, you will want to look inside each option to see the seal design and how it functions. A great seal design ensures the seal will stay in place throughout the actuation steps and that the connector will withstand side-load and tensile forces. Single-use in Final Fill Operation The rising demand of targeted therapies for human diseases indicates a need for a cleaner and more efficient method for transferring monoclonal antibodies. Traditionally, three-way valve assemblies were added to fill and
drain ports to facilitate SIP operations, but the design of these valve assemblies makes it difficult to validate cleaning procedures. Replacing them with singleuse tube sets and connectors can eliminate cleaning validation and maintenance by simplifying connections to mobile stainless steel transfer tanks which are designed to transfer product from formulation suites to storage areas and ultimately to filling suites. Single-use tubing assemblies can either be attached to the mobile tanks prior to equipment sterilization with single-use SIP connectors, or steamed separately, just prior to fluid transfer. For vessel outlet, combining a number of single-use components into the transfer line can create a robust system to ensure product safety. Next, a sterile connector is used to attach the transfer line to a separate portion of the transfer line that has already been steamed onto the filling machine with a single-use SIP connector. Finally a quick disconnect coupling validated as an aseptic disconnect enables the processor to confidently make an aseptic disconnection of the transfer line from the storage vessel when the process is completed Conclusion As the cell culture industry for monoclonal antibodies continues to grow and mature, opportunities are vast but competition will also to stiffen. Biopharmaceutical companies will need to continually innovate and explore new options to gain a sustainable edge over others. Sterile connectors may seem like a trivial component in the elaborate research process of biological therapy for cancer, but the implementation of the right connectors can help establish critical links for achieving desired results accurately, timely, and cost-efficiently, all while continuing to exceed growing industry demands.
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ndia currently ranks fourth in the world among the highest generic pharmaceuticals producers and contributes 20 per cent of global generic drug exports with Brazil, China, India, Mexico, and Russia being the other key players. Many multinational pharma behemoths appear to be taking advantage of the country’s inexpensive labour through India-based subsidiaries. India also boasts lower research and development (or R&D) and manufacturing costs, given government initiatives that support the pharmaceutical sector, including fiscal incentives and streamlined development procedures. The cost of production has been a leading source of India’s industry strength, as India is 60 per cent cheaper than the US and 50 per cent cheaper than Europe in terms of drug production costs. Based on international research, the Indian pharma industry will grow fastest in Finished Dose (generic), followed by API (Generic), Biosimilars, Innovator/ Patented, and finally CRO. Additionally, however, there are now predictions of greater utilisation of domestically sourced APIs for finished drug manufacture.
o a 28 October 2017
With regard to its exports, currently there are two business models targeting two different types of foreign market. The first comprises Western pharma economies, consisting mainly of the United States and Europe. In this market, India is a prime provider of complex generics, branded drugs/OTC, and biosimilars due to its cost-efficient and high quality products. Of course, lately, larger pharma companies are now looking beyond these two Western markets and expanding into Japan. This is a wise move as the Japanese generic use is forecasted to
expand rapidly (after many years of largely on-patent drugs) yielding greater profit opportunities. On the other hand, some of India’s pharma companies are preferring to focus on developing countries as their export market; in particular, on highvolume, low margin products. Besides, with the increasing government investments in healthcare, Indian companies are looking keenly at the domestic market for further expansion opportunities. A troubling increase of lifestyle diseases in India along with the other parts of the globe, is creating a gateway for new drug production prospects and chronic therapies for cardiovascular therapies, anti-diabetes, anti-depressants, and anti-cancers. The incentives for Indian pharma companies to focus on domestic opportunities then are obvious. Biologics and large-molecule drugs are undoubtedly the single biggest development in the pharma industry over the last decade. India, famed for its solid dose capabilities, has been quick to react and is diversifying. Many Indian companies have identifed biologics as their major profit generator moving forward -- particularly with the cost advantages (and higher margins) that biosimilars sales will enable when exported in the US and Europe. Biosimilars are more expensive to make and develop, given higher barriers for entry. However, as a result they deliver a higher margin. This is acting as a key driver in investment decisions. Many believe Indian-made biologics will be able to deliver cost benefits comparable Pharma Bio World
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with what has already been achieved for conventional generics. Furthermore, with patents for 12 biologics expected to expire by 2020, estimates suggest that the global biosimilars market could reach USD 25-35 billion by 2020. Indian companies have a readily-defined market to target and invest in over the next decade. Clearly, there are virtually guaranteed sales to be had. Recently, the pharma industry is seeking to also regulate interchangeability between biosimilars. Thus, it is crucial that Indian biosimilars are closely comparable to Western products to drive growth and increase market share as the regulatory and patent positions become more defined over the next few years. With the Generics market in India having evolved, it provides an ideal platform for pharma professionals to ramp up the ancillary section of the industry to keep abreast with innovations in the growing businesses of the global pharma sector: Increasingly, companies are looking at sub-sectors such as Analytical & Bio Tech, Lab equipments & Lab Chemicals, Pharma Machinery and Packaging with significant success.
process, sub-optimal infrastructure, lack of funding avenues, little or no incentives and a shortage of highly skilled talent, among others. Meanwhile, the US too has witnessed local companies cutting the prices of generic drugs owing to rising competition. Consequently, US -- the largest importer of Indian generics -- has started looking inwards at its own domestic market with big pharmacy chains buying 55 per cent of generic drugs, and smaller firms ordering the rest. Besides, the Indian pharma market has been unable to allay suspicions from developed markets over the compromise that affordable drugs might have in terms of data integrity. The dreaded Form 483 from the US FDA has reached well-reputed brands and includes a range of issues such as lack of proper investigation of market complaints, adverse drug experiences, a lack of written review procedure for stored data, ineffective testing of finished products, and a lack of certain processes to control contamination.
Several challenges continue to surround India’s pharma industry of course. While India is recognised for its affordable, highquality generics and as a global exporter of APIs, it has become more dependent on China’s cheaper API sources. If the latter were to cut the supply, the effect on production could be dramatic as 70 per cent of India’s intermediary formulations are imported from China. (Source: CPhI Pharma Insights, India Market Report 2017)
To combat the several challenges, the government is promoting a resurgence in the Indian API sector to maintain tighter control of the supply chain. It is providing incentives by offering more affordable land and facilities to build API parks. It hopes that this will reduce manufacturing costs by a third and boost competitiveness. It is also proactively encouraging Indian businesses to implement more quality control systems to meet regulatory standards, the Good Manufacturing Practice (GMP) being one such example.
Even in terms of the biotech industry, India faces a gamut of challenges that include a time-consuming approval
As in other sectors, the Govt is zealously committed towards a complete overhauling
30 October 2017
of the system. There is a fairly widely held consensus that the government is leading the agenda and taking a more active role in improving the quality standards. The Central Drugs Standard Control Organization (CDSCO) is moving towards more comparable regulatory standards of the EMA and FDA. It has also set a 1 st January (2018) certification deadline, which when met, should take Indian pharma one-step further in harmonizing with global standards. The recent partnership between the CDSCO, FDA and Indian businesses will no doubt help make approval processes for drugs and manufacturing facilities faster, more efficient and more robust. Over the next few years, the government’s Pharma Vision 2020 aims to make the nation a global leader in end-to-end drug manufacturing. More generally, the country is now rapidly emerging as a major contributor across the pharma supply chain from R&D through to generics. Emerging institutions with centers of excellence, capability development of existing institutions, institution-industry partnership programs, encouraging innate drug development competencies, are being undertaken. The government also plans to review the existing drug price control measures to make medicines more affordable, while also undertaking “re-engineering” of price regulator NPPA. In general, the Government’s initiatives like ‘Start-Up India’, ‘Skill India’ are being taken to the next level through policies that include seed and venture funding to support pharma companies and start ups.
Contact: rohitagnihotri@avian-media.com Pharma Bio World
Natural and Alternative Approaches for Cancer Treatment
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anan a o th partmnt partmnt o pharmactics halapathi nstitt o harmactical cincs Pharma Bio World
T
he term “cancer” is used for the first time by Hippocrates, father of western medicine, who applied Greek words “carcinoma” and “Karakinos” to describe tumor (1) . Cancer begins with mutations in DNA, which instructs the cells how to grow and divide. Normal cells have the ability to repair most of the mutations in their DNA, but the mutations which are not repaired and causing the cells to grow becomes cancerous. It is an abnormal growth of cells in body that can lead to death. Cancer cells usually invade and destroy normal cells. These cells are born due to imbalance in the body so by correcting this imbalance, the cancer may be treated. Cancer is a major public health burden in both developed and developing countries. Billions of rupees have been spent on cancer research and yet do not understand exactly what cancer is. According to the American Cancer Society, deaths arising from cancer constitute 2–3% of the annual deaths recorded worldwide. Thus cancer kills about 3500 million people annually all over the world. Several chemo preventive agents are used to treat cancer, but they cause toxicity that restricts their usage. Statistics showed that hundred years ago only 1 in every 100 people would get cancer. Fifty years ago it dropped to 1 in 50. Today, it’s a staggering 1 in 3 (Soon to be 1 in 2). This is contrary to the researchers and the medical professions telling, we are going backwards real fact with our current approach of orthodox treatments for cancer. National Cancer Institute (NCI) recognized more than 100 types of cancers viz., carcinoma, leukemia, lymphoma and myeloma, central nerve system cancer etc (2, 3) .
Reasons and Preventions for Cancer Nowadays, cancer is considered as a human tragedy. WHO has predicted that number of cancer new cases will reach 15 million in 2020 (4)? The WHO states that up to 70 per cent of cancers are preventable. The four main factors leads changes around the DNA leading to chronic illnesses like cancer are stress, environmental toxins, poor-diet and hormones like oestrogen. These changes are preventable and reversible. Generally exercise, sunshine (vitamin D), sleep and gut bacteria can help in cancer prevention (5-7). The methods used for cancer treatment are; • Orthodox medicine – It tends to focus on surgery, radiotherapy and chemotherapy. • Complementary and Integrative therapy – It includes Tai Chi, meditation, acupuncture, hands on healing, lymphatic drainage. It includes dietary advice and supplements for people on chemotherapy. • Alternative therapy - Diet therapy is an alternative, it is used simultaneously with orthodox medicine. E.g: Virotherapy, Dendritic Cell Vaccines, localised Hyperthermia The survival rate for chemotherapy is only 5years and pathetic of 2-3 per cent. So after 5 years, only 2 to 3 cancer patients out of every hundred are still alive after receiving chemotherapy. (This is definitely not a statistic the cancer industry wants you to find out about, but here having the proof cancer survival rates). Another therapy is the radiation therapy, which actually causes cancer. (Another frightening piece of information the cancer industry won’t reveal to public). But here is the most appalling of all statistics about conventional medical October 2017 31
treatments for cancer. Untreated cancer patients do not die any sooner than patients who receive chemotherapy, radiation and surgery. In fact, in many cases they actually live longer. Dr. Hardin B. Jones, a 40 year cancer researcher and Professor of Medical Physics and Physiology at Berkley, California, did an exhaustive 25 year study on the lifespan of cancer patients and discovered this shocking truth. What he found with breast cancer survival rates was particularly disturbing. He discovered that women who refused orthodox medical treatments actually lived four times longer than women who accepted these conventional treatments (8-11). Dr Otto Warburg won the Nobel Prize in medicine back in 1931 for his groundbreaking discovery on cancer whilst looking into alternative cancer treatments and therapies. He discovered that cancer cannot be survive in any way i.e. shape or form in an aerobic (oxygenated) environment. But it will survive and flourish very nicely in an anaerobic (acid) environment. If the body is stagnant (poorly oxygenated) cancer will grow and thrive. But if it stays constantly oxygenated (alkaline), cancer is dead in the water. The human body has a pH level and it must be maintained above the neutral level (7.35-7.45 to be exact) at all times for optimum health. By keeping the pH of the body above 7, it acts as a “cancer treatment” for itself and works to break down and dispose of any cancerous tumors (12, 13). ACIDOSIS: Cause and Therapies of Cancer Acidosis refers to an acid pH. It is an imbalanced acidic condition of all bodily fluids. Almost all cellular functions in the body are sensitive to the pH of their fluids. If the pH falls too far to the acidic side the cells become poisoned in their own toxic wastes and will die. Many studies 32 October 2017
show that people with a correct blood pH enjoy good health; whereas, people with a low or acidic pH are more likely to be ill. The slightest imbalance can cause serious illness and disease. Acidosis can result in rheumatoid arthritis, diabetes, lupus, tuberculosis, osteoporosis, high blood pressure and most cancers. So in this acidic environment, cancer will not just grow, it will flourish. This was explained by the renowned health expert and founder of The Optimum Health Clinic in London, Alex Howard. The correct pH levels were maintained in the body by different ways (14). They are; 1. The Gerson Therapy and Juicing (15-17) The Gerson therapy targets the most significant metabolic requirements in your body. This therapy allows the people to reap the nutritional benefits of consuming 15–20 pounds by taking organically grown fruits and vegetables each day. The break down was given below; • The Gerson diet – The Gerson diet consists of only organic fruits, vegetables and sprouted ancient grains, which are rich in vitamins, minerals and enzymes; and very low level of fats, proteins and sodium. The meal plan advises cancer patients to drink 13 glasses of freshly prepared juice, eat three plant-based meals and only snack on fresh fruits each day. Also, the traditional Gerson Therapy recommends consuming raw beef liver since it is the most nutrient-dense food on the planet and extremely high in vitamin B12. • Juicing – According to the Gerson institute, “Fresh pressed juice from raw foods provides the easiest and most effective way of providing high quality nutrition.” The cancer-fighting protocol calls for patients to drink fresh vegetables each day, including raw carrots or apples and green-leaf juice.
To preserve the nutritional content, the juice should be prepared hourly using a two-step juicer or a masticating juicer used with a separate hydraulic press. This helps prevent denaturation — when vitamins, minerals and enzymes are destroyed. (Most commercial juicers spin so fast that they heat up juice to the point they are basically pasteurized.) • Detoxification – The Gerson therapy utilizes coffee enemas as the primary method of detoxing the body by increasing the parasympathetic nervous system. For cancer patients, this may take up to five enemas each day. The importance of keeping the body free of toxins is stressed by Dr. Gerson’s daughter, Charlotte. The moment a patient is put on the full therapy, the combined effect of the food, the juices and the medication causes the immune system to attack and kill tumor tissue, besides working to flush out accumulated toxins from the body tissues. This great clearing out procedure carries the risk of overburdening and poisoning the liver, which is already damaged and debilitated in the cancer patients. • Supplements – The Gerson therapy recommends the following organic medicinal therapies: Lugol’s solution, Pancreatic enzymes, Potassium compound, Thyroid hormone and vitamin B12. 2. The Budwig Protocol (18, 19)The Budwig protocol counteracts the cancer causing process. She claimed that 90 per cent success rate was observed with her protocol over a 50 year period. When the deadly processed fats and oils are replaced with life-giving unsaturated/ saturated fatty acids, the body cells rebuild and are rejuvenated. She found that consuming a mixture of cottage cheese, flaxseeds and flaxseed oil had the best Pharma Bio World
results. When cottage cheese (which is rich in sulfur protein and saturated fats) and flax (which is high in electron-rich unsaturated fatty acids) are combined this way, body is able to absorb these vital nutrients easier and quicker. The Bugwig recipe contains 6 ounces cultured dairy (cottage cheese, goat’s milk kefir or amasai), 4 tablespoons sprouted and ground chia or flax, 1 tablespoon flaxseed oil, 1 teaspoon turmeric powder and 1/4 teaspoon black pepper. Mix all the ingredients together in bowl or blender and consume once daily. 3. Proteolytic Enzyme Therapy (20) In 1906, John Beard first proposed that pancreatic proteolytic enzymes represent the body’s main defense against cancer. The autonomic nervous system consists of the sympathetic (“fight” or “flight”) and autonomic (“rest” and “digest”) nervous systems. Dr. Francis Pottenger’s discovered that a vegetarian diet suppresses sympathetic function, whereas the opposite is true with a meat-rich diet. So after dividing patients into different categories based of their metabolic differences, genetic and physical makeup the recommendations are, • People with epithelial tumors like lung, pancreas, colon, prostate, uterine cancers are prescribed a largely plantbased diet with minimal to no animal protein. • People with blood or immune based tumors like leukemia, myeloma or lymphoma are put on a high-animal protein, high-fat diet with minimal-tomoderate plant foods. • In addition, 5 grams of proteolytic enzymes 3 times daily on an empty stomach between meals to reduce inflammation. 4. Vitamin C Chelation (21) Chelation therapy uses chemicals or natural compounds to remove toxic Pharma Bio World
metals from the body. Generally, only holistic doctors and naturopaths use chelation therapy. Because it is not an officially “approved therapy” for most conditions in medicine today. In a study published in Free Radical Biology & Medicine, vitamin C chelation therapy was found to be highly pro-oxidant after just one hour of treatment. Pro-oxidation isn’t always good, but in this case it is. It was discovered that, pro-oxidant effects appear to be responsible for destroying tumor cells. These pro-oxidant effects may also induce endogenous antioxidant systems in normal tissues that offer protection against carcinogenic insult. Along with vitamin C chelation, consuming more vitamin C rich foods may also prevent and fight cancer. 5. Frankincense Essential Oil Therapy (22) This therapy was recommended by Dr. Budwig (fighting brain tumors), frankincense essential oil is one of the most unbelievably effective natural cancer treatments. Specifically, Indian Frankincense (Boswellia serrata) has been shown clinically to being a vital treatment for: Brain cancer, Breast cancer, Colon cancer, pancreatic cancer, Prostate cancer, Stomach cancer. The potential effects of frankincense were due to its ability to influence the genes to promote healing. Baylor cancer scientists emphasize that this potency makes Boswellia serrata a viable candidate for both cancer prevention and treatment. Rub the frankincense essential oil on neck three times daily and drink three drops in 8 ounces of water three times daily. 6. Probiotic Foods and Supplements (23) Probiotics are microorganisms that promote a natural balance in intestinal microflora. The best way to include probiotics in diet is consuming raw milk products such as cheese, kefir and
yogurt. Recent research has confirmed probiotic supplementation can stop tumor growth due to presence of 80 per cent of immune system in the gut. The probiotics can also improve the digestive function and mineral absorption as well as aid in healing leaky gut, which contribute to prevent the cancer. 7. Sunshine and Vitamin D3 Studies revealed that high levels of fatsoluble vitamins and minerals are key to keeping the body free from cancer. Due to consumption of vitamin D3-added supplementation, the risk of developing all cancer types was decreased by 77 per cent. The vitamin D3 is obtained by sun exposure for 20 minutes between 10am to 2pm or by taking oral supplement containing around 5,000 to 10,000 IU of vitamin D3, it is fatsoluble, so take them with food containing coconut oil or a probiotic rich drink like kefir. In market, combination formula of astaxanthin, omega-3 fish oil and vitamin D3 is available (24). 8. Turmeric and Curcumin (25) The curcumin has the anticancer effect. It seems to be able to kill cancer cells and prevent more from growing; it has the best effects on breast cancer, bowel cancer, skin cancer and stomach cancer cells. Studies revealed that the combined treatment of curcumin with chemotherapy killed more bowel cancer cells than chemotherapy alone. It also shown that curcumin interferes with cancer development, growth and spread by blocking the formation of cancer-causing enzymes in rodents. Turmeric helps to stop cancer and effective in treating breast, colon and skin cancer. 9. Oxygen therapy and hyperbaric chambers Dr. Warburg identified the root cause of cancer is oxygen deficiency, which October 2017 33
creates an acidic state in the human body. He also discovered that cancer cells do not breathe oxygen and cannot survive in the presence of high levels of oxygen, as found in an alkaline state. Generally, antioxidants kill free radicals in the body and reverse oxidative stress causing chronic disease. Hence, with oxygen therapy and utilizing a hyperbaric chamber is highly beneficial for people seeking natural cancer treatments. The air pressure inside a hyperbaric oxygen chamber is about 2.5 times greater than the normal pressure in the atmosphere; it causes the blood to carry more oxygen to the organs and tissues in the body (26). 10. Prayer and Building Peace In addition to the many research studies prayer, maintaining mental peace and a positive outlook are absolutely critical to cancer prevention and treatment. Foods and Cancer Risk Food containing sugar, refined oils, refined carbohydrates, conventional dairy products and farm-raised meats causes cancer. Foods that are organic, grassfed, pasture-raised and additive-free can greatly lower the toxic load of the diet. The European Prospective Investigation into Cancer and Nutrition (EPIC) published the data from the investigations that higher intakes of vitamin C, carotenoids, retinol, α-tocopherol and fiber prevents the overall cancer risk (27-33). Widely consuming cancer fighting foods are; • Leafy green vegetables - Leafy greens are the cornerstone of any healthy diet since they are rich in vitamins, minerals, antioxidants and enzymes, very low in calories, fats, sodium and other toxins. They are spinach, kale, collard greens, arugula salad, romaine, watercress etc., which are rich in antioxidants known to combat cancer, 34 October 2017
including vitamin C and beta-carotene. • Cruciferous Vegetables – These are rich with glutathione, known as the body’s “master antioxidant” due to its high free-radical-scavenging abilities. The brassica family of cruciferous vegetables are nutrient-dense sources contains isothiocyanates that are linked to cancer prevention. The cruciferous veggies like cabbage and broccoli are stimulators of detoxifying enzymes that protect the structure of DNA. Many other vegetables are onions, zucchini, asparagus, peppers, carrots, artichokes and beets. • Berries - All types of berries (raspberries, blueberries, cherries strawberries, goji berries, camu camu and blackberries) are top high-antioxidant foods in the world. Berries are especially rich in proanthocyanidin antioxidants, which have been observed to have anti-aging properties in several animal studies and are capable of lowering free radical damage. High amounts of phenols, zeaxanthin, lycopene, cryptoxanthin, lutein and polysaccharides are other berry benefits. Less familiar “superfoods” mulberry, camu camu and goji berries have been used in traditional Chinese medicine since around 200 B.C. to increase immunity and energy. • Brightly Orange-Colored Fruits and Veggies - Brightly colored pigments found in plant foods are a sure sign that they’re beaming with phytochemicals, especially carotenoid antioxidants. The carbohydrate-rich veggies viz., sweet potatoes, carrots, beets, other tubers and whole-grain foods, reduced the risk of several types of cancer, particularly of the upper digestive tract. This is due to more fiber content. • Fresh Herbs and Spices - Turmeric, which contains the active ingredient curcumin, has been shown to decrease
tumor size and fight colon and breast cancer. The curcumin absorption increases in presence of balck pepper and able to fight inflammation. The other herbs that act as immune booster are ginger, garlic, thyme, cayenne pepper, oregano, basil and parsley. • Organic Meats - Organic meats including beef or chicken liver are extremely high in vitamin B12, so they are recommended for cancerfighting. These mineral-rich foods can help counteract the effects of alcohol, prescription drugs, hormone disruptions, high triglyceride levels, low potassium, obesity and viral infections. • Cultured Dairy Products - Cultured dairy products are a rich source of “good bacteria” probiotics, which are microorganisms that promote a natural bacterial balance in intestinal microflora and increase the immunity. Over 80 percent of the immune system is housed in gut, so probiotic foods and supplementation can stop tumor growth and help cells renew. One of the easiest ways to consume more probiotics is taking raw milk, cheese, kefir and yogurt. Cottage cheese, which is rich in sulfur protein and saturated fats, was found to be especially beneficial as part of the Budwig cancer protocol. Probiotics are also present in cultured vegetables like kimchi, sauerkraut and coconut kefir. • Nuts and Seeds – Chia and flax seeds are the most nutrient-dense seeds in the world. They provide fiber, omega-3 fatty acids and a range of important minerals. Hemp, sesame, pumpkin and sunflower seeds are also beneficial and full of healthy fatty acids. Their health benefits and are best sprouted and can be used easily in smoothies, baked goods and with yogurt. • Healthy Unrefined Oils –The widely consumed conventional processed fats Pharma Bio World
and oils are hydrogenated oils and are capable of destroying the membranes of our cells, leading to diseased cells and toxicity. Refined and rancid fats create problems throughout the body, leading to lower immune function, cell congestion and inflammation. The unrefined oils like flax oil, extra virgin olive oil, cod oil and coconut oil nourish the gut and promote better immune function, help to reach and maintain a healthy weight. The flaxseed and cod liver oils also contains essential omega 3-fatty acids that helps in energize the body cells. • Mushrooms - Mushroom species are in existence today, but all are known to be immune-enhancers and many have been used to fight cancer for centuries. Reishi, cordyceps and maitake type mushrooms improve immune function and cell regeneration. • Traditional Teas - Metastasis is the principal cause of death among cancer patients, so it’s one of the most important issues in cancer research today. Several clinical and epidemiological studies have reported that the consumption of green tea can help decrease cancer risk. Green tea contains major polyphenolic compounds, including epigallocatechin-3-gallate, which has been shown to inhibit tumor invasion and angiogenesis, which are essential for tumor growth and metastasis. Teas derived from the leaves of the plant Camellia sinensis are commonly consumed as beverages around the world, including green, black or oolong tea. While all traditional teas seem to be beneficial, the most significant effects on human health have been attributed to green tea, such as matcha green tea. It contains the highest percentage of polyphenolic compounds, catechin, gallocatechin and EGCG. The antioxidant EGCG Pharma Bio World
appears to be the most potent of all the catechins and its anticancer effects have activity about 25–100 times more effective than that of vitamins C and E. EGCG has been reported to be linked to the modulation of multiple signaling pathways, finally resulting in the down regulation of expression of proteins involved in the invasiveness of cancer cells (34, 35). • Wild-Caught Fish - According to Richerche Institute of Pharmacology study conducted in 2004, higher fish consumption provides better immune response.The study found that people who eating less fish and more frequent red meat showed several common neoplasms in their blood that suggested higher susceptibility. Wild and especially small fish including salmon, mackerel and sardines are providing omega-3 fatty acids. They preserve muscle mass and function in chemotherapy of cancer patients. • Supplements: Supplements are useful for helping the body to recover and filling nutrient deficiencies. Studies have shown that people who consume more selenium, folic acid, vitamin B12, vitamin D, chlorophyll and antioxidants have better protection from the disease. A supplementary use of oral digestive enzymes and probiotics is also an effective anticancer dietary measure. Supplements that act as natural therapeutic medications include Vitamin C, pancreatic enzymes, probiotics, potassium compound, vitamin B12, omega-3 fatty acids, super foods including chlorophyll, spirulina, raw cocoa and blue-green algae. Conclusion From the present review, it can be concluded that cancer is considered as a human tragedy. The cancer cells can flourish in the acidic environment, for
controlling the growth of cancer cells pH is playing an important role. As there is an enormous increase in the health care concern of the people, the natural approaches for treating cancer is getting its glimpse. The pH levels in the body can be maintained by different therapies. Along with the therapies by taking good food cancer can be treated easily. References 1. Nobili S, Lippi D, Witort E, Donnini M, Bausi L, Mini E, et al. Natural compounds for cancer treatment and prevention. Pharmacol Res 2009; 59(6):365-78. 2. Jena J. A Study on Natural Anticancer Plants. Int J Pharmaceut Chem Sci 2012; 1(1): 365-8. 3. Dhorajiya BD, Patel JR, Malani MH, Dholakiya BZ. Plant product (R) Roscovitine valuable inhibitor of CDKs as An anti-cancer agent. Der Pharmacia Sinica 2012; 3(1):131-43. 4. Tavakoli J, Miar S, Zadehzare MM, Akbari H. Evaluation of Effectiveness of Herbal Medication in Cancer Care: A Review Study. Iran J Cancer Prevent 2012; 5(3):144-56. 5. Yang G, Li X, Li X, Wang L, Li J, Song X, et al. Traditional chinese medicine in cancer care: a review of case series published in the chinese literature. Evid Based Complement Alternat Med 2012; 2012: 751046. 6. Wang Z, Wang N, Chen J, Shen J. Emerging glycolysis targeting and drug discovery from chinese medicine in cancer therapy. Evid Based Complement Alternat Med 2012;2012:873175. 7. Yang G, Li X, Li X, Wang L, Li J, Song X, et al. Traditional chinese medicine in cancer care: a review of case series published in the chinese literature. Evid Based Complement Alternat Med 2012; 2012:751046. 8. Qi F, Li A, Inagaki Y, Gao J, Li J, October 2017 35
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Kokudo N, et al. Chinese herbal medicines as adjuvant treatment during chemo- or radio-therapy for cancer. Biosci Trends 2010;4(6):297307. Dhanamani M, Devi SL, Kannan S (2011) Ethnomedicinal plants for cancer therapy- a review. Hygeia J D Med 2011; 3: 1-10. Azadmehr A, Hajiaghaee R, Afshari A, Amirghofran Z, Refieian-Kopaei M, yousofi Darani H, et al. Evaluation of in vivo immune response activity and in vitro anti-cancer effect by Scrophularia megalantha. J Med Plants Res 2011;5(11):2365-8. Naveen Kumar DR, Cijo George V, Suresh PK, Ashok Kumar R. Cytotoxicity, apoptosis induction and anti-metastatic potential of Oroxylum indicum in human breast cancer cells. Asian Pac J Cancer Prev 2012;13(6):2729-34. Otto Warburg, 2009. Nobel Prize Web site. Available online: http:// nobelprize.org/nobel_prizes/ medicine/laureates/1931/warburgbio.html (accessed on 15 September 2009). Warburg O, Posener K, Negelein E. Über den Stoffwechsel der Carcinomzelle. Biochem Zeitschr. 1924;152:309–44. Goldfeder A. Über die in bösartigen Geschwülsten vorkommenden pHWerte. Zeitschr Krebsforschg. 1929;29(1-2):134–46. Gerson C, Walker M. The Gerson Therapy. 60 years of proven success! Kensington Publishing, USA; 2001. Gerson M. A Cancer Therapy. Results of Fifty Cases, 6th Ed. Bonita, CA: Gerson Institute, 1999. Austin S, Dale EB, DeKadt S. Longterm follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies. Journal of Naturopathic Medicine. 1994; 5(1):74-76. Budwig, J. Flax Oil as a True Aid
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against Arthritis, Heart Infarction, Cancer and OtherDiseases; Apple Publishing Company: Vancouver, BC, Canada, 1994. Budwig, J. Photo-elements of life as an anti-carcinoma factor, successful as a preventive and in the progressive state of the illness. Minerva Ginecol. 1971, 23, 115–117. Kaufmann, H.; Budwig, J. Die PapierChromatographie auf dem Fettgebiet VII: Nachweis und Trennung von Fettsäuren. Fette und Seifen 1951, 53, 390–399. Henderson B. 2010. Beating Cancer Gently Web site. Available online: http://www.beating-cancer-gently. com/buybook.html (accessed on 21 June 2010). Budwig, J. Cancer: The Problem and the Solution; Nexus: Kernen, Germany, 2005. Research digests. PLoS Biology. 2004: 2(2); 0140. Henderson B. Cancer-Free: Your Guide to Gentle Non-Toxic Healing, 2nd ed.; Booklocker.com: Bangor, ME, USA, 2007. Roomi MW. Ivanov V, Kalinovsky T, Niedzwiecki A, Rath M. Antitumor effect of nutrient synergy on human osteosarcoma cells U-2OS, MNNGHOS and Ewing’s sarcoma SK-ES.1. Oncol. Rep. 2005, 13, 253–257. Natural Standard Online Database, 2009. Available online: http://www. naturalstandard.com. ezproxy.lib. u c a l g a r y. c a / i n d e x . a s p ? f i l e = / h t m l / about.html (accessed on 9 October 2009). Natural Standard grading scale, 2009. Available online: http://www. n a t u r a l s t a n d a r d . c o m . e z p r o x y. l i b . ucalgary.ca/monographs/flashcards/ flashcard-spirulina.asp (accessed on 9 October 2009). Peirce A. The American Pharmaceutical Association Practical Guide to Natural Medicines;
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Stonesong Press Book: New York, NY, USA, 1999. Lee JE, Mannisto S, Spiegelman D, Hunter DJ, Bernstein L, van den Brandt, PA. Intakes of fruit, vegetables, and carotenoids and renal cell cancer risk: A pooled analysis of 13 prospective studies. Cancer Epidemiol. Biomarkers Prev. 2009, 18, 1730–1739. Lin J, Kamat A, Gu J, Chen M, Dinney CP, Forman MR, Wu X. Dietary intake of vegetables and fruits and the modification effects of GSTM1 and NAT2 genotypes on bladder cancer risk. Cancer Epidemiol. Biomarkers Prev. 2009, 18, 2090–2097. Chavarro JE, Stampfer MJ, Hall MN, Sesso HD, Ma J. A 22-y prospective study of fish intake in relation to prostate cancer incidence and mortality. Am. J. Clin. Nutr. 2008, 88,1297–1303. Melnik BC. Milk—the promoter of chronic Western diseases. Med. Hypotheses 2009, 72, 631–639. Angelo LS, Kurzrock R. Turmeric and green tea: a recipe for the treatment of B-chronic lymphocytic leukemia. Clin. Cancer Res. 2009, 15, 1123– 1125. Roomi MW. Ivanov V, Kalinovsky T, Niedzwiecki A, Rath M. In vivo antitumor effect of ascorbic acid, lysine, proline and green tea extract on human colon cancer cell HCT xenografts in nude mice: Evaluation of tumor growth and immunohistochemistry. Oncol. Rep. 2005, 13, 421–425. 35. Mousa SA. Antithrombotic effects of naturally derived products on coagulation and platelet function. Methods Mol. Biol. 2010, 663, 229– 240.
Contact: prasanthi_pharm@yahoo.com sarvanmani@gmail.com Pharma Bio World
Market Research
2QFY18E Results Preview - Amey Chalke and Siddhant Mansukhani, HDFC Securities Institutional Research
U
nlike the last two quarters, the Indian pharma sector will witness some relief in 2QFY18, largely led by certain one-off factors. Channel re-stocking will help many companies in the India branded business, and a couple of significant launches in the US market will provide a further boost. For our coverage universe, we foresee a 15 per cent sequential jump in revenues, and the EBITDA margin to move up to 22 per cent from 18 per cent QoQ. On a YoY basis, we expect single-digit top-line growth. 2HFY18 is again likely to be soft, with no visibility on resolution of the FDA issues of large companies like SUNP and DRRD. Cliffhangers; The Halol
specialtybusiness remain key triggers for SUNP post 2QFY18. However, any further delay in the resolution and a negative outlook for the specialty business would lead to significant earnings cuts for FY19/FY20, as Taro’s business continues to erode. Similarly, DRRD’s fate is tied to key product launches in 2HFY18, like gCopaxone and gNuvaring. However, further negative regulatory developments at Duvvada (WL) and Bachupally (483) will suppress any recovery.
~250bps YoY, driven by the gLialda launch in the US. ARBP is also likely to report buoyant numbers on account of the gRenvela launch in Jul-17. The outlook for rest of the year remains strong for both companies, with key launches in the pipe for the US market.
Sequential recovery: Unlike the last few quarters, LPC is likely to witness sequential growth in its top-line, led by higher sales in India and flattish US revenues. DISH is also likely to see growth return, with Niraparib sales reflecting from 2QFY18. DIVI to report PHARMACEUTICALS : 2QFY18E RESULTS PREVIEW Making hay: CDH and ARBP are likely improved profitability, with remediation to report strong growth in both revenue costs having tapered down. CIPLA, and earnings in 2QFY18. We expect ALKEM, ALPM and TRP will also deliver SUNP and DRRD: CDH’s top-line to grow~27% YoY, and improved performance on the back of the resolution and the an EBITDA margin improvement of pick-up in the India branded business.
Top picks: CDH, LPC, ALKEM, DISH and GRAN
Expect ~2% YoY Rev Growth For Our Coverage Universe Revenues (Rs bn)
%YoY Growth - RHS
350.0
20.0
340.0
15.0
330.0
10.0
320.0
5.0
310.0
-
300.0
Pharma Bio World
Overall EBITDA Margin To Improve Sequentially
2QFY18E
1QFY18
4QFY17
-15.0 3QFY17
270.0 2QFY17
-10.0 1QFY17
280.0 4QFY16
-5.0
3QFY16
290.0
October 2017 37
2QF
1Q
4Q
3Q
2Q
1Q
4Q
3Q
Market OverallResearch EBITDA Margin To Improve Sequentially EBITDA (Rs bn)
EBITDA Margin (%) - RHS
100.0
30.0
80.0
25.0 20.0
60.0
15.0 40.0
10.0
20.0
5.0
2QFY18E
1QFY18
4QFY17
3QFY17
2QFY17
1QFY17
4QFY16
3QFY16
-
Source: Company, HDFC sec Inst Research
2
B p Company
2QFY18E
WHAT'S LIKELY •
S u n Pharma BAD
•
• Lupin
Dr Reddy's Labs
AVG
•
• GOOD
•
• Torrent AVG Pharma
38 October 2017
•
KEY MONITORABLES
The top-line is likely to decline ~15%, owing to increasing pressure on Taro's business and a lack of • generic launches to offset pricing pressure in the base • business. Domestic business is likely to post strong growth, given channel re-stocking • EBITDA margin to show some sequential improvement on the back of a better business mix. However, this will be limited by erosion in Taro's business
FY18 generic launch guidance Updates on Halol facility reinspection Specialty pipeline progress
Lupin is likely to post 4% revenue growth sequentially. • Recovery in the domestic business will be a significant contributor to this. • EBITDA margin will be ~22.5%, up ~300bps QoQ. A • significant YoY decline will be seen, owing to the sales of gGlumeta and
Visibility on significant product launches in the US market in 2HFY18 Commentary on erosion in gGlumeta and gFortamet
gRenvela launch in the US will lead to 15% YoY topline growth in2QFY18 Assuming at least 75% EBITDA margin for gRenvela, we expectthe company's overall EBITDA margin to ump ~370bps QoQ to26.8%
FY19 Base business growth in the US market Capex and debt reduction plan
• • •
Aided by the boost to the Indian market on the back of • GST re-stocking, we expect TRP's top-line to grow 6% YoY on a high base of 2QFY17 (includes gAbilify) xpect EBITDA margin to be at ~21% (up 100bps) in • 2QFY18E, with positive operating leverage on account of higher India sales
Update on filings for the US market and near- term product launches Commentary on domestic business recovery in 2HFY18
Pharma Bio World
Market Research Company
2QFY18E
WHAT'S LIKELY ••
Alembic AVG Pharma
•• •• ••
A l k e m GOOD Labs •• •• Cadila VERY GOOD Healthcare •• •• Cipla
AVG ••
D i v i ' s GOOD Labs
•• ••
•• Dishman Carbogen AVG Amcis
••
•• Glenmark
AVG
Pharma Bio World
••
KEY MONITORABLES
Similar to TRP, ALPM is also likely to report flattish YoY growth on a high base of 2QFY17 (includes gAbilify), •• helped by recovery in the domestic business post GST EBITDA margins to see significant (300bps) sequential •• improvement in 2QFY18, with a better business mix
Guidance on new product launches in the US market Additional capex plans
With close to 70% revenues from the domestic market,channel re-stocking should see overall top-line to •• grow 11-12%in 2QFY18. US business will remain more or less flat •• EBITDA margin to post strong recovery at ~20% vs 7.3% in 1QFY18
Commentary on US business ramp-up from 2HFY18 OTC plans and spending
2QFY18 is expected to be a very strong quarter for •• Cadila, with the launch of gLialda under exclusivity and channel re-stocking in the India business. Foresee ~27% •• growth YoY EBITDA margin too will be strong at ~24.5%, up ~250bps YoY
Guidance on other significant approvals such as transdermals Guidance on the launch of gAsacol HD
With a domestic heavy portfolio, Cipla is likely to post better numbers in 2QFY18, largely on account of channel •• re-stocking. Foresee ~7% top-line growth EBITDA margin will expand to ~19.5% owing to a favourable business mix during the quarter
Commentary on launch of limited competition opportunities in the US
Foresee ~10% top-line growth YoY, led by first-time sales •• from Niraparib Operating leverage to drive EBITDA margin higher •• sequentially to ~26%. This would be more or less flat YoY
Visibility on further commercial launches Recovery of orders deferred in 1QFY18
•• Revenue to begin picking up at 8% growth YoY, with the •• business expected to expand quickly in the second half of the year •• EBITDA margin to be at 21.5%, up ~100bps YoY. Improvingbusiness mix and operating leverage will drive •• margins higher
Update on ANDA filings Management commentary on US business progress Visibility on high-value API launches from Omnichem recently-cleared facility
Revenue to begin picking up at 8% growth YoY, with the •• business expected to expand quickly in the secondhalf •• of the year EBITDA margin to be at 21.5%, up ~100bps YoY. •• Improvingbusiness mix and operating leverage will drive margins higher ••
Update on ANDA filings Management commentary on US business progress Visibility on high-value API launches from recently-cleared Omnichem facility
October 2017 39
PHARMACEUTICALS : 2QFY18E RESULTS PREVIEW
Market Research
Financial Summary Fnana Smmay
NET SALES (Rs bn) Company
EBITDA (Rs bn)
2Q FY18E
QoQ (%)
YoY (%)
2Q FY18E
EBITDA Margin (%)
QoQ (%)
YoY (%)
2Q FY18E
QoQ (bps)
Sun Pharma
70.2
13.1
(15.1)
15.3
39.5
(51.8)
21.8
Cadila Healthcare
29.9
36.2
27.2
7.4
165.3
42.5
24.6
1195.3
Cipla
40.0
13.4
6.6
7.8
21.0
14.9
19.6
Lupin
40.6
4.8
(5.4)
9.3
20.6
(13.7)
22.8
Aurobindo Pharma
42.8
17.6
14.6
11.5
36.4
23.5
Dr. Reddy's Labs
37.4
12.8
4.3
6.5
114.0
9.9
9.3
13.0
(7.7)
2.9
18.3
Divi's Labs
APAT (Rs bn)
YoY 2Q (bps) FY18E
411.9 (1,656)
Adj. EPS (Rs/sh)
QoQ (%)
YoY (%)
2Q FY18E
1Q FY18
2Q FY17
9.2
74.5
(59.0)
3.8
2.2
9.3
264
5.5
295.0
61.9
26.7
6.8
16.5
122.4
142
4.4
N/A
24.1
5.5
5.1
4.4
299.3
(218)
5.1
42.9
53.2
11.3
7.9
7.4
26.8
369.2
192
7.6
45.3
28.4
13.0
8.9
10.3
17.5
827.8
89
3.0
413.4
2.9
18.3
3.6
17.8
(0.5)
31.2
141.5
226
2.2
28.3
(2.9)
8.2
6.4
8.4
Alkem Labs Torrent
18.4
42.3
12.5
3.7
290.6
18.7
20.0
1271.4
105
2.9
302.3
1.8
24.1
6.0
23.7
Pharma Glenmark
15.2
10.6
6.3
3.4
14.1
2.7
22.3
68.4
(79)
2.0
6.3
(3.5)
11.8
11.1
12.2
Pharma Alembic
23.9
2.6
10.0
4.8
(12.1)
20.2
20.0
-334.4
169
8.6
(25.8)
8.0
8.6
11.5
7.9
Pharma Dishman
8.8
37.6
1.1
1.7
65.0
(5.9)
19.0
315.4
(140)
1.1
60.2
(10.9)
5.7
3.5
6.4
Carbogen Granules
4.8
41.4
10.0
1.2
77.7
7.5
25.9
529.9
India Aggregate
(60) 0.5 264.2 (13.2) 2.9 0.8 3.4 PHARMACEUTICALS : 2QFY18E RESULTS PREVIEW 113 0.5 22.4 10.7 2.0 1.6 1.8
3.9
3.7
8.0
0.8
9.8
14.0
21.5
118.3
345.3
15.3
1.8
76.3
42.2
(11.9)
22.1
417.3 (345.9)
52.4
41.1
(10.7)
Source: Company, HDFC sec Inst Research
Peer Valuation aaon EPS (Rs/sh)
P/E (x)
RoE (%)
Company
Mcap CMP Reco (Rs bn) (Rs/sh)
TP
FY17
FY18E
FY19E
FY20E
FY17
FY18E
FY19E
FY20E
FY17
FY18E
FY19E
FY20E
Sun Pharma
1,279
531
NEU
525
26.0
15.8
23.0
30.8
20.5
33.6
23.1
17.2
17.9
10.1
13.6
16.1 6
Cadila Healthcare
509
496
BUY
570
14.5
14.4
18.8
25.9
34.1
34.5
26.3
19.1
23.5
19.0
20.5
23.3
Cipla
470
585
NEU
565
12.5
18.4
24.7
31.7
46.8
31.9
23.7
18.5
8.4
11.2
13.5
15.2
Lupin
467
1,040
BUY
1,605
57.0
49.4
69.5
87.1
18.3
21.0
15.0
11.9
20.9
15.6
19.0
20.1
Aurobindo Pharma
427
729
BUY
820
39.3
40.1
48.0
51.8
18.6
18.2
15.2
14.1
27.6
22.5
21.8
19.3
Dr Reddy's Labs
409
2,409
SELL 2,300
72.7
77.2
123.4
165.2
33.2
31.2
19.5
14.6
9.5
10.0
14.5
17.0
Divis Labs
233
880
NEU
795
39.9
33.2
41.1
47.0
22.0
26.5
21.4
18.7
22.0
15.6
17.4
17.9
Alkem Labs
225
1,878
BUY
2,060
74.6
64.9
87.9
108.2
25.2
28.9
21.4
17.4
21.9
16.3
19.2
20.3
Torrent Pharma
213
1,257
BUY
1,400
51.2
46.9
64.8
84.2
24.5
26.8
19.4
14.9
22.1
17.8
21.9
23.9
Glenmark Pharma
172
610
BUY
1,025
29.6
27.2
46.9
59.0
20.6
22.5
13.0
10.3
18.1
14.1
20.2
20.9
Alembic Pharma
95
503
BUY
650
21.4
21.0
27.7
37.2
23.5
24.0
18.1
13.5
23.0
19.4
21.8
24.2
Dishman Carbogen
51
317
BUY
405
9.0
12.3
16.7
23.8
35.1
25.8
18.9
13.3
11.6
13.3
15.2
17.8
Granules India
29
126
BUY
190
7.2
8.4
10.6
13.3
17.5
14.9
11.9
9.5
21.0
19.6
20.7
22.2
Source: Company, HDFC sec Inst Research
Fo a ona
Amey Chalke, Siddhant Mansukhani HDFC securities Institutional Equities Unit No. 1602, 16th Floor, Tower A, Peninsula Business Park, Se napati Bapat Marg. lower Pare I. Mumbai- 400 013 Board:+91-22-6171 7330 www.hdfcse c.com 40 October 2017
7
Pharma Bio World
marketing initiative
Armacell India Adds New Products to its Innovative Portfolio
A
rmacell India Adds New Products to its Innovative Portfolio
Armacell is a world leader in flexible insulation foams for the equipment insulation market and a leading provider of engineered foams. In 2015, the company with currently approx. 2,900 employees and 24 production plants in 15 countries generated net sales of EUR 540.2 million. Armacell operates two main businesses: Advanced Insulation develops flexible foams for the insulation of technical equipment utilized for the transport of energy - such as heating, ventilation & air conditioning (HVAC) and heating & plumbing (H&P) in residential and commercial construction, process lines in the heavy- and oil & gas industry, equipment in transportation, as well as, acoustics.
Engineered Foams develops highperformance foams for the use in a broad range of end markets including transportation, automotive, wind energy, sports and construction. Armacell´s products significantly contribute to global energy efficiency. In line with the innovative product portfolio worldwide, Armacell India has recently launched 2 products with focus on various industries. Armaflex ® Alu E is the latest offering from Armacell India which combines excellent fire performance with superior aesthetics and forms a complete insulation solution for the Pharmaceutical industry. The other offering from Armacell India Pvt. Ltd. is Class 0 Armaflex® with Arma-Chek ® GC specially designed in 5 different colors to combine mechanical & UV protection with aesthetic value.
Armaflex ® Alu E : Superior Performance Insulation specially designed for the Pharmaceutical Industry Clean rooms are one of the most demanding applications in Pharmaceuticals industry, when it comes to insulation. Hygiene become the most important aspect of clean room application. The ducts and pipes are visible and hence should be easy to clean and aesthetically appealing. They should not retain any moisture and prohibit any possibility of microbial growth, and of course, conserve energy with minimum heat loss/gain. High Performance Aesthetic covering
Insulation
with
The traditional Aluminium-clad insulation products have always faced an ever
Figure 1: ArmaChek GC Range Pharma Bio World
October 2017 41
marketing initiative substrates. Arma-Chek ® GC is now available in various colors like Red, Blue, Green & Grey in addition to the original Black covering material. Class 0 Armaflex ® with Arma-Chek ® GC prevents condensation, reduces energy losses, prevents scratch/mechanical damage and protects against frost on pipes, air ducts and vessels. It is suitable for hot and cold water services, chilled water lines, heating systems, air conditioning ductwork, refrigerated pipework, process and industrial pipework and equipment. Arma-Chek ® GC is an economical covering system with good resistance to mechanical impact and scratch. The combined system of Arma-Chek ® GC along with Armaflex ® substrate forms a Class 0 fire performance and is FM approved.
Figure 2: Armaflex Alu E Sheet
existing problem of ugly dents, wrinkles and pockets. Thanks to the unique surface pattern, the Armaflex ® Alu E cleverly disguises most of the imperfections that may occur during installation. The cladding is embossed with Armaflex ® brand to avoid any counterfeiting which also lends an overall premium feel to the cladding. It’s highly flexible nature further aids fast and easy installation in technical sections. Water vapour and humidity are one of the biggest hindrances in enabling thermal insulation. With water vapour diffusion resistance (µ) of 60000, Armaflex ® Alu E ensures that the insulating properties are retained in the most adverse conditions. Moreover the surface can be wiped clean effortlessly which helps in keeping the fungi and microbes at bay, another prerequisite of a clean room application.
of the building. Insulation materials are mostly at the forefront and exposed to fire in its early stage. The responsibility to arrest fire propagation naturally comes to insulation. With compliance to strict norms laid down by Building Regulations, Armaflex® Alu E has a big ace up its sleeve. It passes all the requirements of Class 1 as per BS476 Part 7 for surface spread of flame and Class 0 as per BS476 Part 6 and meets Fire category as per 1991 Building Regulations (England & Wales) and the Building Standards (Scotland) Regulations 1990. Armaflex ® Alu E is a non-fibrous, non-itchy, easy-to-clean product. Hence, there is no probability of air contamination due to degradation of the insulation material over a period of time.
Fire
Class 0 Armaflex® with Arma-Chek® GC: Economical Pre-covered Armaflex® System For Resistance To Mechanical Impact
In the unfortunate event of a fire breakout, the last thing anybody would want is propagation of the fire to the other sections
Arma-Chek ® GC is a flexible, woven glass fibre covering system for long term mechanical protection of mechanical
Insulation with performance
42 October 2017
Superior
Now available in new colors! Arma-Chek ® GC covering is now available in 3 new colors viz. Red, blue and Green in addition to the existing Black and Grey. The new colors not only add to aesthetics but also aids in identification of different pipelines (e.g. hot & cold lines). Arma-Chek ® GC is available in pre-covered sheets and tubes as well as separately as Glass Cloth covering along with accessories.
For details contact www.armacell.in. Pharma Bio World
marketing initiative
Automatic Control Loop Tuning New software components for easy hydraulics control
B
&R is introducing new software damage caused by overloading or components for controlling cavitation. hydraulics applications. These components provide easier access to If autotuning is used during operation, advanced closed-loop control functions the machine software can automatically and assist developers in the design, recalibrate the controller fol-lowing simula-tion, virtual commissioning and changes to environmental conditions diagnosis of hydraulic systems. B&R or other factors such as load forces or mapp Hydraulics provides numerous characteristics. new functions, particularly for variableAutomatic calculation of maximum speed pump drives. values Automatic control loop tuning Another mapp Hydraulics component With the autotuning function, the automatically calculates the maximum system automatically optimizes acceleration and deceleration values the control loop parameters for the for a hydraulic drive. The drive moves hydrau-lic pressure controller. This autonomously within the operational boosts both quality and system limits defined by the user to identify the performance. Optimized pressure maximum values for a given hydraulic control parameters also help prevent axis. This significantly shortens
Figure 1: mapp Hydraulics software components provide convenient access to advanced closed-loop hydraulic functions. Pharma Bio World
commissioning times for hydraulic axes. mapp Hydraulics software components provide convenient access to advanced closed-loop hydraulic functions. About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.
For details contact www.br-automation.com. October 2017 ď‚„ 43
marketing initiative
Condition Monitoring for Mobile Equipment Higher machine availability with mobile X90 control system
T
he modular X90 control and I/O system can now be equipped with condition monitoring functions. Problems can be detected in their early stages and corrected before they result in unplanned downtime. Conditionbased predictive maintenance can maximize machine availability and save the considerable cost of outages and unplanned service calls. Predictive maintenance
The X90 module allows operators to continuously monitor the status of mobile equipment. The results help determine exactly which components require maintenance and when. Typical applications include continuous monitoring
of rotating machine components such as hydraulic assemblies, belts, gears and motors. The processed sensor data is also available for further use in the application. About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK
and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.
For details contact www.br-automation.com.
Figure 1: The optional condition monitoring circuit board provides early warning of impending failures on mobile equipment.
44 ď‚ƒ October 2017
Pharma Bio World
marketing initiative
Minimalistic Design. Maximum Information. Need for Climate Monitoring Systems A better understanding of indoor climate in industries and its impact has become crucial to define and implement appropriate mitigation and adaptation policies, including investment policies for large infrastructure with long lifecycles. This in turn, has hiked the demand for climate monitoring systems considerably over the recent decades, which further increases the fundamental need for authoritative climate information and services upon which to base strategic plans, investments and day-to-day decisions. To make this task of climate monitoring easy, wireless & aesthetically soothing, testo has now introduced its NEW range of data loggers for building climate monitoring, named as TESTO 160. This new range of data loggers from testo with its 5 different models, help you keep your monitored locations aesthetically perfect, thanks to its small size and deco-covers which helps it to blend with the surroundings.
Comprehensive technology
and
wireless:
The
The monitoring system testo 160 measures, monitors and documents temperature, humidity, light intensity, UV radiation, CO2 concentration, atmospheric pressure, continuously, precisely and automatically. This serves ambient climate monitoring and also preservation of valuable objects or systems. The data loggers transfer the measurement values by wireless LAN to an online store, the Testo Cloud. From there, they can be called up by PC/tablet/smartphone from any place with internet access. If individually defined upper or lower limit values are exceeded, an alarm notification gets activated. For light intensity, an alarm can also be triggered if the accumulated light quantity within a day, a week or a month exceeds a limit value.
Unobtrusive and individual: The product design The data loggers are specially designed such that they present themselves discreetly and inconspicuously. Thanks to the deco-cover, they also blend in with any background. These optionally available housing covers can be individually painted or decorated. Just as the respective background requires. The loggers have internal and/or external sensors. The latter are, thanks to their design and size, ideal for monitoring in small glass cases, in which otherwise a data logger cannot be placed. Application areas: The testo 160 climate monitoring system find applications in: • Facility Management • HVAC Maintenance • Malls & Offices • Hotels & Airports
Figure 1: KeyVisual-testo-Saveris-2-Map-testo-160-edition
Pharma Bio World
October 2017 45
marketing initiative
Figure 2: testo-160-IAQ-application
• Cold Storages & Warehouses And find Special Applications in: • Showcases & Display Spaces • Museums & Archives • Libraries & Archives Choose your model. The testo 160 climate monitoring system, consists of 5 different models that suits your application and measurement needs.
WiFi data logger testo 160 THL is more than just an easy-to-use climate logger for humidity and temperature monitoring. Thanks to additional integrated sensors for lux and UV radiation, it provides accurate information about the light conditions. • Testo 160 E WiFi data logger testo 160 E adapts perfectly to your climate monitoring requirements. It offers 2 connection options for probes for temperature, humidity, lux or lux and UV radiation.
• Testo 160 TH. WiFi data logger testo 160 TH is an easy-to- • Testo 160 IAQ use data logger for monitoring temperature The easy-to-use WiFi data logger testo and humidity with an integrated temperature 160 IAQ is ideal for monitoring indoor air quality. Thanks to its integrated sensors for and humidity sensor. temperature, humidity, CO2 and atmospheric pressure, it accurately determines the climatic • Testo 160 THE WiFi data logger testo 160 THE is an easy-to- conditions in rooms. It can also perform longuse data logger for monitoring temperature term measurements without any difficulty. and humidity with an integrated temperature and humidity sensor. It also has an option to Testo is recognized as the leading worldwide connect up to 2 additional probes (ordered manufacturer of portable measuring separately) for temperature, humidity, lux or instruments for various parameters. We aim to provide the best quality, service and lux and UV radiation. value in the industry and thus are committed to satisfy our customer needs for precise • Testo 160 THL measurement and monitoring by offering 46 October 2017
them the best technological advancements in the industry for their daily measurement needs. About Testo India Testo India Pvt. Ltd. is a 100% subsidiary of Testo SE & Co. KGaA, with its headquarters in Lenzkirch in the Black Forest, Germany. Established in 2006 Testo India has shown phenomenal growth over the last 11 years with its head office in Pune, & a PAN India network. At Testo, we understand the customer requirements; therefore, pay constant attention to new technology and our highest priority is Innovation. We, as a market leader take everything concerned with the product seriously: service, support and availability. We commit – before sale, after sale and in all phases of application.
For details contact www.testo.com info@testo.in Pharma Bio World
marketing initiative
Liquid Ring Vacuum Pump Vexations
O
ur liquid ring vacuum pump repeatedly tripped during high pressure, high flow conditions at startup.
When It finally started, the pump ran noisily. On inspection, we noticed it was installed backwards. We reversed the direction of the pump but got only low vacuum and the motor became very hot- exceeding the temperature ratings on the motor Insulation. We're operating at 300 torr with water. Why did the pump operate, though noisily, with the flow reversed? What is causing it to run so poorly now? Is the pump shot? Take a Number of Steps Installing and operating a liquid ring vacuum pump (LRVP) backwards will severely Impact Its operation. On these machines, the vapor inlet port Is several times larger than the outlet port. When operated backwards, the smaller discharge port (now acting as the inlet) will cause a restriction and impede the flow of vapors Into the LRVP. The resulting turbulence will create unusual noises.
After the rotation was corrected you report the motor became very hot. Assuming there are no problems with the motor itself,high motor temperature would Indicate high horsepower draw. Ampere readings can be taken off the motor leads to verify the approximate horsepower draw. High draw Is often the result of : 1. high discharge pressure 2. mechanical problems such as a bad bearing, foreign object or product buildup Inside the machine 3. high seal liquid flow rate. First, verify the discharge pressure Is within design by checking the pressure at the separator vessel. Be sure to check the pressure during startup, as the higher mass flow rates can result in high pressure downstream of the LRVP. To check for internal mechanical problems without disassembly of the LRVP, remove the coupling and rotate the pump by hand. Check for severe binding or scraping, or other problems. Some scraping, especially if you can still rotate the pump by hand,is not unusual and can be Ignored. However,a stainless pump can't tolerate any scraping.If stainless, have the pump repaired immediately
I f the above checks are okay, you may have too high a seal flow rate.Install a regulating valve, compound pressure gauge (or better yet a flow meter) and temperature gauge In the seal liquid piping near its entrance into the LRVP. With the pump operating in vacuum service, the seal liquid pressure reading should typically be close to O psig. Compare your readings against the manufacturer's recommendations. If necessary, throttle back the seal liquid flow and you should see improvement in the power draw. As a final check, look at the temperature rise of the seal liquid. Compare the seal liquid inlet with the LRVP discharge. A temperature rise of 10 - 15*F is typical. Readings well outside these values should be further investigated. “ Is the pump shot?" Once the horsepower issue is solved, you can concentrate on performance. However, more information is needed. How does the operating level of 300 torr compare to design? How does the mass flow rate from your process compare to design? Is the process load constant or does it change during operation? How accurate is the pressure gauge that is being used? Very important and often overlooked: the pressure gauge must be an absolute pressure gauge, and must be recently calibrated. If the mass flow rate from the process can't be measured,can the non-condensable flow rate be measured downstream of the LRVP, perhaps by adding a rotameter at the separator discharge? Do this in a manner that the rotameter is only used to check capacity, as hard piping it can lead to back pressure, especially during startup. Finally, an off-line capacity test can be performed. Disconnect the LRVP suction from the process and run a dry air test using an appropriately sized set of orifices. Compare the test results to the book performance curve to evaluate the condition of the LRVP. For details contact Toshniwal Instruments (Madras) pvt ltd 267,Kilpauk Garden Road Chennai - +91 44 26445626 / 5626 Email : sales@toshniwal.net Website : www.toshniwal.net
Pharma Bio World
October 2017 ď‚„ 47
press release A Vaidheesh Elected President of OPPI The Organisation of Pharmaceutical Producers of India (OPPI), which represents research-based pharmaceutical companies in India, has unanimously elected Mr. A. Vaidheesh, Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceuticals Ltd as President for the year 2017-18. He takes over from Dr. Shailesh Ayyangar, Managing Director, India & Head - South Asia, Sanofi who held this position since 2013. The four elected Vice Presidents are Sharad Tyagi, Managing Director, Boehringer Ingelheim; Sanjiv Navangul, Managing Director, Janssen India (Pharmaceutical Companies of Johnson & Johnson Ltd); S. Sridhar, Managing Director, Pfizer Ltd and Anand Nambiar, Managing Director, Managing Director, Merck India Ltd. Speaking on his appointment, A. Vaidheesh, President- OPPI said, “I am honoured to be taking over the responsibility as President OPPI. Today, we are at the intersection of technology and medicine and the future of healthcare seems to be progressing towards ‘personalised’ medicines and ‘personalised’ patient-care. The pharmaceutical industry has an important role to play in delivering responsible healthcare and we look forward to partnering with the Government and other stakeholders in realizing the collective dream of a Healthy India. This dream can become a reality only when science and research deliver new cures for the unmet medical needs; thereby fostering an environment of innovation. On the policy front, I am sure that the National Health Policy and the National IPR Policy will lead the way for better health outcomes. Along with an inclusive ecosystem, in the coming years, healthcare financing will also play its role in improving access to healthcare. I believe we at the OPPI have clear priorities and along with the OPPI Secretariat led by Kanchana TK, Director General, OPPI, we will together work towards serving more patients in India ”
Clariant Launches MEVOPUR PEAM 176045 Clariant, a world leader in specialty chemicals, announces a new amide/amine-free anti-static masterbatch concentrate for polyethylene films used in pharmaceutical production. The new anti-stat, known under grade name MEVOPUR PEAM 176045, will be introduced at CPhI Worldwide, being held 24 - 26 October 2017 at Messe Frankfurt. Clariant is exhibiting on Stand 42L20. The introduction is timely due to the changes in industry standards which, by 2020, will limit the acceptability of many of the currently used films that contain amide- and amine-based anti-stats, says Stephen Duckworth, Clariant’s Head of Global Segment Medical and Pharmaceutical. For the first time, plastics used in pharma manufacturing, including anti-static films, will need to comply with the same standards as plastics packaging used for finished pharmaceuticals. 48 October 2017
“Anti-static additives are routinely incorporated in the polyethylene ‘clean-room films’ that line containers and dispensers for active pharmaceutical ingredients (APIs), and in the tubes used to transfer powdered and liquid API during drug production. They are important because the anti-static properties help to reduce the risk of dangerous conditions like explosions,” he explained. The new additive masterbatch concentrate is part of MEVOPUR, the brand of ‘Controlled, Consistent and Compliant’ products for plastics applications in the medical and pharmaceutical industries. When incorporated into PE films Clariant’s new anti-static provides very good static-dissipating performance and a competitive cost profile relative to alternatives. In addition, it has already been tested to the stricter new United States Pharmacopeia (USP) pharmaceutical standard for pharmaceutical-contacting plastics, which are scheduled to come into force in 2020. The new standard -- USP<665> ‘Plastic Components and Systems Used in the Manufacturing of Drug Products’ -- will, for the first time, apply the same risk-based assessment of materials. Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, these plastic assemblies elicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety.
Hilleman Receives Indo-Swedish Grant for Developing OCV Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, received a 6 million krona Indo – Swedish grant for the project ‘Improved, affordable single strain whole cell-B subunit oral cholera vaccine’. The proposed project, carried out by Hilleman Laboratories, is being jointly funded by the Department of Biotechnology (DBT), Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems. The project will fuel further Research & Development of the Oral Cholera Vaccine (OCV) with knowledge exchange and transfer of scientists across India and Sweden. Speaking on the partnership, Dr Davinder Gill, CEO Hilleman Laboratories said, “Cholera remains a threat to global public health and is a barometer of health inequity and lack of social development. Considering the urgent need for effective and affordable Cholera vaccines, both for use in Cholera outbreaks and in mass vaccination campaigns, we would like to accelerate development of our simplified Oral Cholera Vaccine, HILLCHOLTM.” Pharma Bio World
press release Price Caps Helps Indian Medical Danone India Launches Protinex Bytes Device Makers Grow Positively: AiMeD Danone India, part of a leading global food company Danone, which Association of Indian Medical Device Industry (AiMeD) has announced that the price cap on medical devices such as knee implants and heart stents is helping the domestic medical device market grow manifold. Hailing the price control measures, Mr Rajiv Nath, Forum Coordinator, AiMeD said “In the last six months, we have seen a positive trend towards increased sales for domestic manufacturers. This is more so in Tier 2 & Tier 3 towns due to higher affordable access post reduction of prices. We estimate that this trend shall continue and boost the idea for manufacturing and the Indian manufacturers will grab 60% of the market share by next year.” Mr Rajiv Nath said “Heavy lobbying is going on and pressure has increased on India to revise its stance on price caps for medical devices and not to extend it to other devices, but India should do what’s good for India and give advantage mainly to the common citizens who now have access to the best products at the most affordable prices and to domestic manufacturers.” The lobbying against Price Capping is being done by MNC importers with overseas factories claiming to be Indian Industry when none of these makes stents in India. We await the announcements of price cap on other devices notified as Drugs e.g. heart valves, Intra Ocular Lens and Syringes and Infusion Products. NPPA had exercised their powers to stop total withdrawal to avoid market shortages of dominant players. From AiMeD’s viewpoint it need not do so and after 6 months moratorium any importer can leave the market if he does not want to play it - but here it’s not about an importer abandoning the market, it’s actually more about market rationalisation while wanting to make the Indian Government look bad. Seemingly DoP has now relented and permitted withdrawal to one brand of Abbot, over riding the NPPA order which wanted supplies to be available and maintained for a year.
Claris Completes Sale of its Stake in JV to Otsuka Claris Lifesciences Limited has announced that it has completed the sale of its remaining 20 per cent stake in Otsuka Pharmaceutical India Private Limited; the joint venture with Otsuka Pharmaceutical Factory, Inc. and Mitsui & Co. Ltd; to Otsuka Pharmaceutical Factory, Inc. (Japan) for a consideration of USD 20 million. The agreement to sell was announced on May 8, 2017 “Claris sells its stake in JV to Otsuka” Pharma Bio World
has a mission ‘to bring health through food to as many people as possible’, today announced the launch of Protinex Bytes, a specially formulated protein rich, on-the-go nutrition snack for everyone with busy lifestyles. Consumers today are looking for convenient food supplements that provide adequate nutrition anywhere, anytime.
Protinex Bytes has been launched nationally. It is available in Vanilla Flavour in two SKUs of 100 gms and 200 gms for Rs. 145 and Rs. 280 respectively. Protein is an essential nutrient at every life-stage. Inadequate intake of protein can lead to tiredness. fatigue and loss of muscle mass associated with aging. Indian diets are inadequate in protein and majority of the proteins are obtained from cereals which are not a source of good quality proteins. It is important to consume good quality protein throughout the day to meet the protein requirements and activate body protein synthesis. The current formats are available in powder form and are required to be mixed in milk. Protinex Bytes is a more convenient format of a food supplement which not only helps meet nutritional requirements but is also a tasty and healthy on-the-go snack option. Five Protinex bytes provide more proteins (8g) than 1 glass of milk or 1 egg (6g).
Agilent Launches Triple Quadrupole Mass Spectrometer in India Agilent Technologies Inc has introduced the newest member of its family of triple quadrupole liquid chromatography mass spectrometers (triple quad LC/MS) at the Analytica Anacon India, being held on 21st September through 23rd September in Hyderabad, India. The Ultivo triple quad is a transformative approach to LC/MS that integrates several hardware and software innovations designed to deliver even more improved business results for customers. Ultivo is optimized to address the food and environmental routine testing segments employing triple quad LC/MS systems for quantitative analyses. Ultivo delivers robust performance, superior uptime, and easier serviceability, in a footprint that is 70% smaller than previous instruments. Customers can now significantly increase their analytical throughput without having to increase the size of their existing laboratories. In addition to its trendsetting size, Ultivo provides reproducible, reliable assays that result in exceptional performance in complex matrices. Greater ion transmission efficiency leads to optimized sensitivity; and improved, intelligent diagnostics use intuitive readbacks that can quickly identify issues, ensuring optimum uptime. Furthermore, Ultivo’s new VacShield vacuum provides vent-less ion injector exchange capabilities that reduce wear and tear and facilitate rapid front-end maintenance. October 2017 49
press release LifeCell Respectfully Challenges ICMR’s Recommendations The Indian Council of Medical Research (ICMR) had made recommendations in its National guidelines to stem cell research, 2017, to suspend commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In its recommendation ICMR which functions under the health ministry had stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells. Accordingly, the ICMR has issued guidelines stating that commercial banking of all other biological materials, other than UCB, is not permitted until further notification. Mr Mayur Abhaya, CEO & Managing Director of LifeCell - India’s largest umbilical cord stem cell bank today questioned the hurried decision of ICMR in this guideline recommendations for preserving vital stem cells from cord tissue, menstrual blood and other biological material without considering many aspects. He commented that the decision does not carry a rationale for many reasons which he elaborated. Mr Mayur Abhaya, CEO & Managing Director, LifeCell said “The decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood and other biological sources is very unfortunate and totally overlooks the potential contribution of stem cells in research and development. Though today, applications of these are restricted, research and advanced clinical trials across the globe on these products have been demonstrating a significant progress. It is only a matter of time when these stem cells could become treatment solutions for many disorders that have very few other options for treatment.” Now, if the contention is that these cord tissue and other MSC stem cells are going to be used for treatments today, if that is the concern of ICMR then the answer is a clear “No” since they have not been approved for therapies.
Regenerative Medicine Set to Shake up the Therapy Market In what could be a radical shake-up of the healthcare sector, regenerative medical procedures such as stem-cell or gene therapy hold the promise of completely curing diseases rather than simply treating them. With the pharmaceutical industry’s business model currently based on treating incurable diseases with drugs, regenerative therapies are mostly being developed in specialist clinics and trial situations. Despite the rapid expansion of the market for new therapies – anticipated to grow 33 percent per year from 2020 through 2025 – Big Pharma show a striking lack of involvement and therefore risk missing out on a slice of this significant market. 50 October 2017
Regenerative medicine could produce new therapeutic interventions for cancers, genetic disorders or autoimmune diseases. Stemcell therapy, for example, can restore damaged tissue or even regenerate entire organs. In a revolution for patients, many of whom have had to rely on medication for years, the focus is shifting from treatment to cure. And the market for regenerative medicine is set to grow rapidly, from a value of EUR 20 billion today to somewhere in the region of EUR 130 billion by 2025. These are among the findings of the latest study by Roland Berger, “Regenerative medicine – The next generation of therapeutic products is set to shake up the pharmaceutical world”. “Regenerative medicine has the potential to turn the healthcare sector upside down for all involved: health insurers, hospitals and pharmaceutical players alike,” says Roland Berger Partner Thilo Kaltenbach. “As regenerative medicine becomes established over the coming years, it is going to transform the drug market in particular.”
GNC Strengthens its Presence in India GNC (General Nutrition Centre), headquartered in Pittsburgh, US, and a leading global specialty health, wellness, and nutraceuticals retailer, is strengthening its presence in India through its association with Guardian Healthcare, the official importer and seller of GNC products in India. Globally, GNC is a multi-billion brand and has around 9,000 locations and franchise operations in approximately 50 countries. In India, Guardian Healthcare Services Pvt Ltd. has tied up with GNC as a sole franchisee with exclusive distribution and marketing rights. Founded by Mr Ashutosh Taparia, who has over two decades of expertise in healthcare, Guardian has a vision of establishing thought leadership position in Indian nutraceuticals market. GNC products are now available online on the e-commerce portals as well as at the retail outlets of Guardian Healthcare and other pharmacy chains. Guardian aims to make GNC range available at 4000 stores across all Metros & Tier 1 towns by 2020. Built on 80 years of superior product quality and innovation, GNC is committed to help Indian consumers in better managing lifestyle issues such as fatigue, stress, vitamin deficiencies, and cholesterol amongst others through the principles of ‘Scientific Nutrition’. With the objective of laying foundation for “Live Well” amongst the Indian consumers, GNC has identified four building blocks of nutrition - Multivitamins, Omega-3’s, Proteins, and Probiotics. As many as 91 percent vegetarians and 85 percent non-vegetarians among Indians were deficient in proteins according to the survey titled ‘Protein Consumption in the Diet of adult Indians Survey’ (PRODIGY). GNC India is endeavouring to build the cause of #BuildingBlocksofNutrition to raise awareness about missing blocks in nutrition amongst Indians. It refers to need for bridging the gap between insufficient nutrition intakes in our day to day diet with the assistance of health and nourishment products. Pharma Bio World
Nitrile Gloves Cole-Parmer offers ThinTouchPROtect nitrile gloves – a line extension of company’s ThinTouch range of gloves. Specially formulated, designed and tested to stringent standards, the gloves provide user with max assurance, superior comfort and enhanced tactility. They are tested against 29 chemotherapeutic drugs as per ASTM D 6978-05. They have exceptional breakthrough time even for Carmustine (3.3 mg/ml) – 127.5 mins and ThioTepa (10.0 mg/ml) – 240 mins. Manufactured using a unique formulation - they undergo series of exhaustive tests to ensure these are the best in the category. The gloves are highly chemical-resistant and are qualified for oncology production and research applications. The anti-static property with resistivity of 1X107 Ohms at humidity 51% - makes these gloves an ideal choice in processes demanding low electrostatic discharge.The glove has a great tactile feel for wearer comfort over extended period of use. Its unique colour provides visual differentiation from other natural rubber latex and synthetic gloves. ThinTouchPRotect Nitrile Gloves are available in 9.5” and 12” length and S to XL sizes. These are ambidextrous with beaded cuffs ensuring ease of donning and have textured fingertips for enhanced wet or dry grip. The gloves have low-particulates to prevent glove-related work contamination. For more information, please contact: Cole-Parmer India 403, A-Wing, Delphi Hiranandani Business Park, Powai Mumbai 400 076 Tel: 022-61394410, 61394444 Fax: 91-022-61394422 E-mail: vinita.singh@coleparmer.in
Triple Quadrupole Mass Spectrometer Agilent Technologies Inc offers triple quadrupole liquid chromatography mass spectrometers (triple quad LC/MS). The Ultivo triple quad is a transformative approach to LC/MS that integrates several hardware and software innovations designed to deliver even more improved business results for customers. Ultivo is optimized to address the food and environmental routine testing segments employing triple quad LC/MS systems for quantitative analyses. In addition to its trendsetting size, Ultivo provides reproducible, reliable assays that result in exceptional performance in complex matrices. Greater ion transmission efficiency leads to optimized sensitivity; and improved, intelligent diagnostics use intuitive readbacks that can quickly identify issues, ensuring optimum uptime. Furthermore, Ultivo’s new VacShield vacuum provides vent-less ion injector exchange capabilities that reduce wear and tear and facilitate rapid front-end maintenance. Ultivo’s seamless integration with the Agilent MassHunter Software suite provides high-performance instrument monitoring, data acquisition, analysis, and reporting for currently regulated and emerging environmental contaminants and pollutants in our water supplies. Also, Ultivo’s fine-tuning ensures rigorous accuracy, with selectivity, sensitivity, and precision monitoring, to deliver specific identification and quantitation of a wide range of contaminants, helping keep our worldwide food supplies safe.
For more information, please contact:
Agilent Technologies Inc 5301 Stevens Creek Blvd Santa Clara, CA 95051, U.S.A. Tel: +1 408 553 2005, +45 29 33 69 80 E-mail: victoria.wadsworth-hansen@agilent.com
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Multi-channel Pipetting
Tubular Vials Kapoor Glass offers high quality vials on latest servo-controlled German and Italian lines for exceptional accuracy. Vials are produced with Japanese hot-end and cold-end camera vision systems for dimensional inspection of all critical parameters. Robotic loading directly from the tube bundle and automatic feeding of glass tubes minimises human intervention and improves yield and efficiency whilst reducing scratches. Kapoor Glass follows the tightest EC AQL limits and US Military Sampling plan to ensure consistently high quality supplies. Vials can be offered as per DIN/ISO specifications as well as customized to specific requirements.
For more information, please contact: Kapoor Glass Kapoor House, A-37, Street No: 2, MIDC Andheri (E), Mumbai 400 093 Tel: 022-28323475, 28374651 Fax: 91-022-28379403 E-mail: info@kapoorglass.com
INTEGRA’s extensive range of manual and electronic handheld pipettes – combined with the revolutionary GripTips system – is helping take the ‘pain’ out of multi-channel pipetting, boosting productivity and ensuring happy, healthy staff.INTEGRA’s handheld multi-channel pipettes and GripTip system have been developed to allow tips to effortlessly snap onto the pipette and ensure they are always firmly attached, perfectly aligned and easily ejected.
For more information, please contact: INTEGRA Biosciences AG Tardisstrasse 201 CH-7205 Zizers Switzerland
Multi-mill Multi-mill available in standard cGMP and customised models with SS-304/316/316L contact parts. It is ideal equipment for the granulation of pharma material. Precision designed to grind/compress/impact and shear in an effective manner. Most suitable for granulating, pulverizing, mixing, shredding and kneading of a range of wet and dry material. Features low energy consumption and high degree operation; facilitates automation capability and dust-free product transfer; helps to reduce containment and cross-contamination; and provided with butterfly valve for discharge. It is available in batch capaciites ranging from 50 to 500 kg as per particle size.
For more information, please contact:
IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar, Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com
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Evisceration System Principle of the system is to recover any substance from the main product for further process. The system is built in fabricated structure incorporated with vacuum pump motor, automatic valves, pipings, switches and control panel. The capacity of the vessel for collection of the substances is approximately 200 litres. The vessel is manufactured in food grade SS-316. The liquid ring vacuum pump develops vacuum in the vessel. The suction nozzles are bypassed through the storage vessel to its connecting point. The suction nozzle functions with vacuum sensor which is connected to foot-operated switch on both sides of the unit for dual operation. Indovac provides hydro/pneumatic circuit for automatic disposal of the substance to other subsequent processes as may be feasible and as per the customersâ&#x20AC;&#x2122; needs. This system is used mainly in sea food process, pharma industries, chemical applications, distillation and recovery processes in any industry. For more information, please contact: Indovac Pumps & Engg Co 21 Anand Raj Indl Estate, Sonapur Lane B/h Asian Paints, Off LBS Marg Bhandup (W), Mumbai 400 078 Tel: 022-25664917, 65062751 Telefax: 91-022-25664917 E-mail: indovac@yahoo.co.in
GC/Q-TOF System Agilent Technologies Inc offers a new high-resolution, accurate-mass system designed for laboratories doing food and environmental testing, life science research, forensics and chemical analysis. The Agilent 7250 GC/G-TOF system combines gas chromatography and quadrupole time-of-flight mass spectrometry with a Low Energy Electron Ionization source that enables greater exploration of unknown chemical samples. The new system represents the only commercially available combination of a high-resolution, accurate-mass GC/MS and lowenergy ionization source, making it possible for scientists to employ analytical techniques that were not previously practical or in some cases even possible. The capabilities of the 7250 GC/Q-TOF system will now allow labs to quickly and easily identify volatile and semi-volatile compounds that, in the past, would require them to perform alternative techniques or longer sample preparations to detect and determine the compounds present in their samples. Furthermore, with Low Energy Electron Ionization, scientists will be better able to elucidate chemical structures. Agilent offers a range of GC/MS technologies for both qualitative and quantitative analysis across a wide variety of applications. For more information, please contact:
Agilent Technologies Inc 5301 Stevens Creek Blvd, Santa Clara, CA 95051, U.S.A. Tel: +1 408 553 2005, +45 29 33 69 80 E-mail: victoria.wadsworth-hansen@agilent.com
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Refrigerated Incubators The new Thermo Scientific refrigerated incubators provide optimal temperature conditions for applications that require thermal stability and uniformity above, around or below the usual ambient laboratory temperature. These systems are also suitable for standard 37°C incubation applications in warm laboratory environments. Available in both a benchtop and a more spacious floor-standing unit, the new Thermo Scientific RI-150 and RI-250 models of refrigerated incubators have been equipped with key attributes to enable ease-of-use, while facilitating temperature uniformity and precise temperature setting for optimal sample safety and reproducibility of results. These systems are suitable for use in a range of pharma, life science, water treatment, biological research and microbiology applications, including incubation of bacteria and yeast, water testing, hatching of insects and fish, sample storage at specific temperatures and biochemical oxygen demand (BOD) testing. For more information, please contact:
Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494, Fax: 91-022-67429495 E-mail: sagar.chavan@theromofisher.com
Hydro MPC Pumps with IE5 Motor Grundfos India offers its new range of Hydro MPC pumps with the IE5 Motor. The Grundfos Hydro MPC booster systems are of high standards and combining this with the IE5 motor, which is integrated with a frequency converter, connects the accumulated pump experience of Grundfos into the dedicated control software. This combination of pump and customizable software optimizes your system’s performance for any load point, delivering an unsurpassed reduction of energy consumption. Grundfos IE5 Motor, which helps in energy conservation of up to 7 per cent and a reduction in the payback time of these controlled pumps. The Hydro MPC pumps with IE5 Motors will be available with systems that are pre-configured from the factory with variety of pump sizes to increase water boosting. For more information, please contact:
Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai Thoraipakkam, Chennai 600 097 Tel: 044-45966800, 45966896 Fax: 91-044-45966969 E-mail: mahathi@grundfos.com / salesindia@grundfos.com
Walk-in Humidity Chamber Mack Pharmatech Pvt Ltd offers walk-in humidity chamber in the temperature range of 20°C to 60°C; humidity range 40%RH to 95%RH; accuracy ±0.2°C and ±2.0% RH; uniformity ±1.0°C and ±3.0%RH. Test is suitable for 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH; and 30°C and 75%RH. Features PLC-based control system; 21 CFR software; HMI (touch screen display); standby refrigeration system; standby humidity system; imported Hygroflex sensor; 8+8 sScanner; GSM technology; hooter system; full view glass door and GMP mode.
For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nasik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com
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Laboratory Freezers Laboratories can now rely on Thermo Fisher Scientific’s expanded line of cold-storage products to help them meet their goals for both productivity and sustainability. The company recently earned the US Environmental Protection Agency’s (EPA’s) ENERGY STAR certification for its Thermo Scientific TSX Series ultra-low temperature freezers, which is designed to reduce energy consumption while ensuring sample protection. Now, researchers can choose from the wide range of ENERGY STAR certified ultra-low freezers, including the Thermo Scientific TSX, Forma 89000, Revco RLE, TLE and the HERAfreeze HLE Series. To reduce energy consumption, the certified freezers incorporate features such as the unique V-drive technology that continually detects and adapts to user patterns to provide temperature uniformity throughout, fast door opening recovery and lower heat emissions to reduce HVAC costs. In addition, the refrigerants used in the freezers have been approved by the EPA’s Significant New Alternatives Policy (SNAP) program, which evaluates substitutes for ozone-depleting substances to reduce overall risk to human health and the environment.
For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com
Platinum Cured Silicone Hose Imawrap is platinum cured silicone hose reinforced with SS-316L helical wire and 2-3 layers of polyester fabric wrapping. Imawrap is having multiple layers of high quality polyester fabric to enhance burst pressure rating. The product is suitable for high pressurized steam transfer application in pharma and biotech industries. Imawrap conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and Animal Origin Certification (free of animal derived material), free of restricted heavy metals. It is free of Phthalate/Bisphenol/Volatile Plasticizer. It has US FDA DMF accreditation #26201. Complete validation package available upon request. Imawrap has high pressure rating ensures safe material transfer handling process. It is designed for high vacuum rating applications. It has excellent flexibility and kink resistance. It imparts no taste and odour. It is lot traceable. Its temperature range is -80°C to 180°C. It is available with SS-316 L Tri-Clover end. It is sterilizable by Autoclave, Ethylene Oxide Gas and Gamma Radiation. For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com
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Multi-Parameter Transmitter Mettler Toledo Process Analytics offers a new version of its multi-parameter M400 transmitter series for process analytics applications. The new M400 features a combined touchscreen and a tactile soft-key interface. Parameters covered by the M400 Series address the needs of the process industries from chemical applications to pharmaceutical production.The new series is compatible with analog sensors and Mettler Toledo’s digital Intelligent Sensor Management (ISM) probes. ISM’s features include advanced sensor diagnostic tools that can be displayed on the M400 and accessed remotely via asset management software. The HART communication protocol provides integration of the diagnostics into process control systems. In addition, ISM sensors can be calibrated away from the process in any convenient location, then connected to the M400 which will set itself up appropriately. A software tool supplied with the transmitter enables configuration of the M400 via PC and USB stick. The configuration can then be shared among other M400s. This simplifies setup and enhances batch configuration efficiency. For more information, please contact:
Mettler Toledo India Pvt Ltd 36/37 Jolly Maker Chambers II Nariman Point, Mumbai 400 021 Tel: 022-22024046, 22850516, Fax: 91-022-22029278 E-mail: deplmum@vsnl.com
Connected Solutions for Higher Process and Product Safety Bosch Packaging Technology shows how Industry 4.0 solutions help to achieve higher process safety and product quality. Detailed information about each machine, line or process status is provided by the Condition Monitoring platform. It records data in realtime, enabling maintenance staff to react before cost-intensive process deviations or downtimes occur. To ensure constant product quality, all process steps are subject to strict regulations. The Bosch Pharma Manufacturing Execution System (MES) enables pharma companies to take the step towards a transparent, paperless production. To this end, Bosch works with the software provider Parsec Automation Corp and configures the MES software TrakSYS according to the requirements of the pharma industry. Together with a complete audit trail, it includes all necessary functionalities to manage machines and processes, and to generate electronic batch records (EBR), thus facilitating the approval for batch releases by qualified persons. The Bosch Pharma MES can be integrated into any Bosch or third-party machines and lines, as well as into complete manufacturing facilities. When it comes to packaging, the unambiguous serialization of secondary packaging aims at protecting patients from counterfeit medicine ensures the traceability along the production chain. The Track & Trace solution fulfills both requirements. It consists of the CPI software and machine modules, which are connected within the serialization process. At the machine level, CPS modules print data matrix codes on to folding cartons, verify the codes and if required, equip the packaging with a tamper-evident seal. The CPI software integrates the CPS modules into the company IT. This ensures a reliable serialization from the allocation of the serial numbers through to the last aggregation step. For more information, please contact: Commha Consulting GmbH & Co KG Poststraße 48 D-69115 Heidelberg, Germany Tel: +49 6221 18779-27 E-mail: bosch@commhaconsulting.com
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Mini CORI-FLOW CORI-FILL technology features an integrated batch counter function together with the facility to directly control shut-off valves, proportional valves or (gear) pumps. Due to this technology, CoriTech can offer compact assemblies of (mini) CORI-FLOW instruments combined with a valve or pump, capable of dosing the exact desired amount of fluid. In contrast to the gravimetric method (weighing scales), multiple fluids can be dosed simultaneously. Further more the scales need to be re-zeroed when switching from one fluid to another, whereas instruments with CORI-FILL technology just require a short reset command to start the next batch. The amount to be dosed can be easily preset by programming the batch counter via a field bus connection. This batching method is faster and more compact than the gravimetric method, and highly accurate.As a result of their small footprint it is possible to mount the (mini) CORI-FLOW instruments directly to the shut-off valves, thereby minimizing the internal volume, resulting in a fast response time and the highest accuracy (minimum delay-effects in the piping). It is applicable for the pharma, chemical, food and beverage industries.It finds application in dosage of additives, fragrances, flavours, colorants, H 2O 2 (for sterilization) in continuous or batch blending processes. For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net
Processing Machine for Production Scale Romaco Innojet offers a new Series of the VENTILUS technology for production scale applications. The LE (Light-Edition) can be supplied in three different versions: LE-D, LE-G and LE-C. The LE-D Series is specifically intended for drying processes while the LE-G is designed for granulating fine solid particles and the LE-C for coating them. Furthermore, Innojet continues to offer the established Premium Edition integrating all VENTILUS process steps and features. The Premium machines allow the ROTOJET – the central bottom spray nozzle – to be exchanged and cleaned without interrupting operation. Different coating liquids can be applied in this way. Users who simply require the VENTILUS in order to dry the fluidised bed are well served by the low-cost LE-D version. Romaco Innojet can also provide integrated solutions for wet granulation with an upstream high-shear mixer as well as systems for wet and dry milling. All components are connected to the VENTILUS LE-D fluidised bed dryer via an enclosed material transfer system. Control, data recording and cleaning of the Romaco Innojet processing line take place centrally. Romaco Innojet VENTILUS V 100 LE-C, which combines all three processing steps – drying, granulation and coating – contains the same core components as the Premium Edition with a central ROTOJET spray nozzle and an ORBITER booster. The rapid, homogeneous distribution of the spray liquid helps achieve shorter processing times and improved product quality. The solid particles are fluidised extremely gently in a controlled process based on the innovative air flow bed technology developed by Dr H C Herbert Huttlin. The production scale systems in the VENTILUS Series are designed for batch sizes from 40-1,600 litres.Larger batch volumes are possible on request.
For more information, please contact:
Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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Direct Drive Pumps Over three decades of expertise in vacuum technology, Toshniwal offers customized solutions ranging from individual products to a complete system. Toshniwal’s direct drive high-vacuum pumps, the 72-D Series doublestage model is with ultimate vacuum. These vacuum pumps are compact, since they are directly mounted on motor flange. These pumps have pumping speeds and high water vapour tolerance. The oil consumption is extremely low and air cooled.72-D Series highly reliable double stage 120-1,000 LPM portable pump with advanced lubricating system offers improvement in the areas of quieter operation and easy maintenance. For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net
Oval Gear Meter The measurement element of this positive displacement oval gear meters consists of two precision oval gears. The revolution can be sensed by a magnetic-field-controlled pulse generator, resulting in only two moving parts, ie, ovalwheels. These oval gear meters can be used for application of nearly all operating condition.Features very high/very low temperatures; low and extreme high viscosities; nominal diameter DN 4 to DN 400; direct measurement of volume respective of volumetric flowrate; measurement at high viscosities and high accuracy; and 2-wire-technique.
For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk garden Road, Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshnwial.net
Central Vacuum System TPN Series pump provide the ultimate vacuum of 0.5 mbar with high capacity required for centralized vacuum system. TPN Series guarantees the highest performance compared to other small on-board single stage oil-lubricated vacuum pump and this TPN pumps are ready to use machines designed for easy installation and trouble-free integration into industrial process. Design and efficiency of mechanical parts guarantee low power consumption and provide added value in terms of sustainability and reduced operation cost.The closed-loop lubrication circuit ensures negligible coolant consumption prevents air and environment contamination with harmful substances and reduces maintenance requirement. Therefore, TPN Series vacuum pump offer best return of investment and low life cycle cost.Features air cooling system through an aluminum radiator and electric fan thermostat for operating without cooling water. No coolant consumption thanks to the closed-loop lubrication circuit and high efficiency separation element. Coolant separator and recovery for clean air exhaust without treatment. Durability and efficiency guaranteed by the special aluminum alloy vanes that ensure constant performances even after tens of thousands of hours of operation. They are ready-to-use machines that can be easily and directly connected to the vacuum plant and the power supply without foundations. Limited footprint thanks to the compact layout designed to minimize the space needs. It has direct coupling between motor and air-end to avoid energy losses. It has a sound-proof cabin to reduce noise impact. Fully automatic operation: intake valve regulated by safety vacuum switch, coolant temperature control, thermostat and auxiliary control switches. Control panel complete with main power switch, easy to operate. For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net
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New Platform of HMI Workstations Eaton has expanded its range of MTL GECMA HMI workstations, introducing two new products – a Thin Client (TC) and Personal Computer (PC) version. The company can now offer a complete range of workstations based on a common platform design. As such, Plant Managers can reduce operation costs, optimise productivity and increase plant safety, with the additional benefits of reducing space in the cabinet and future-proofing the plant. The TC and PC versions complement the existing MTL GECMA Remote Terminal (RT) which has a unique modular design. These next generation HMIs feature state-of-the-art technology to offer unparalleled levels of safety and are approved to global hazardous certification for Zone 1 environments. As a result they offer safe handling on site and guarantee high reliability in hazardous EX zone areas in chemical, pharmaceutical, refinery plus the oil and gas industries worldwide. The TC version is designed for virtualisation applications, eg. batch control. The workstation works with a client server in the safe room across a LAN. This saves space in the cabinet as users do not need a dedicated PC and the user can control up to 255 HMIs from a single server. The PC version is stand-alone working across the LAN. It has state-of-the-art system hardware, which meets the needs of the most complex applications with high computing power demand, eg, packing. The workstation has a watch dog function which automatically monitors the operating system and if there is no input from the system it automatically re-starts itself. This avoids hard re-starts, which saves time associated with turning the system On and Off, and minimises any stress on the system for increased reliability. RT is a point-to-point device, with one workstation assigned to one PC in the safe area. It features a keyboard, mouse and video, and is perfect for controlling tablet coating or dry granulation machines. The RT terminal’s modularity means upgrades to existing installations are quick and easy, which can save time, and minimise costly maintenance and downtime. Traditionally, the whole unit would have to be dismantled off-site, but with MTL GECMA, individual parts can be replaced simply on-site, increasing plant availability.
For more information, please contact: Eaton Butterfield, Great Marlings Luton, Bedfordshire LU2 8DL, U.K. Tel: +44 (0)1582 723633 E-mail: mtlenquiry@eaton.com
Single Stroke Tablet Press The newest generation of Romaco Kilian’s STYL’ONE Evolution single-stroke press has been upgraded with a whole set of innovative features. The compression cycles have been speeded up by more than 60 per cent and the max compression force increased to 50 kN in order to simulate high speed presses. Compression force profiles for all standard rotary presses like the Romaco Kilian KTP 420X can now be determined at full power. ANALIS, the intelligent PAT software, calculates all relevant tableting parameters based on compression force or displacement controlled cycles. The remarkable precision of the test batches means powder properties can be analysed realistically. This scalable tableting robot can thus be utilised not only for R&D projects but also to optimise existing processes or troubleshoot errors.The redesigned STYL’ONE Evolution achieves a max output of 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets. Moreover, cleaning and maintenance of the Romaco Kilian STYL’ONE Evolution are now much easier owing to the status lamps and utility connections integrated in the machine frame. For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com
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Pharma Bio World
bookshelf Quality Assurance & Quality Management in Pharmaceutical Industry (Paperback) Author: Anjaneyulu Marayya Price: USD 142.12 No of pages: 360 pages Quality Assurance is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS GLP GMP Quality Audit Statistical Quality Control and analytical methods for QA. The elements requirement and interpretation of ISO 9000 series of QMS are presented in detail. The principles of GLP and GMP are discussed which are expected to guide the manufacturer and the regulator for maintaining high scientific and professional standards for ensuring only drugs of highest quality are produced and marketed. Each chapter is provided with a summary and typical questions and in Appendix the latest information on the international Standards of QMS GLP and GMP are included for ready reference.
Quality Assurance for Biopharmaceuticals (Library Binding) Author: Jean F Huxsoll Price: USD 199.00 No of pages: 216 pages Quality Assurance for Biopharmaceuticals provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. This book discusses what systems are needed along with a description of each system and its functions. In this book, leading authorities in the biotechnology industry offer insight and suggestions in order to assure the safety, purity and efficacy of products produced.
Applying Lean Six Sigma in the Pharmaceutical Industry (Hardcover) Author: Bikash Chatterjee Price: USD 104.42 No of pages: 170 pages Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Pharma Bio World
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Pharma Bio World
R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MCS/207/2017-19 Posted at Patrika Channel Sorting Oï¬&#x192;ce, Mumbai 400001, on 27th of every month. Total Pages:- 64