interview from prevention (vaccines) and diagnosis (diagnostics) to treatment (biologics). The overall strategy is to continuously consolidate the market position by building a robust pipeline and enhance our product portfolio. What is a virus-like particle, and how is it produced? Virus Like Particles (VLPs) are similar to a virus in structure but without the genetic material required for viral replication. VLP vaccines are created by incorporating the gene sequences of multiple immunogenic proteins to produce a complex envelope particle vaccine. The end result is highly immunogenic spherical structures that are roughly the same size as original virus. The vaccines are manufactured in the wellestablished insect cell/BV recombinant platform which is the basis for several licensed biologic products and vaccines, including a vaccine licensed for Human Papilloma Virus (HPV), which showed >95 per cent effectiveness in reducing the incidence of cervical cancer. We can use the insect cell/BV technology to produce a wide range of vaccine candidates derived from viruses, bacteria and protozoan parasites. Please elucidate the essential role of VLP technology in new-generation vaccines?
and Nano-particle technology completely takes that risk away providing safer and more effective vaccine compared to other available vaccines. Finally, because of the structure and components of our VLPs, they may have greater immunogenicity in two vulnerable populations - pediatrics and older adults. What are the other significant developments in vaccine manufacturing that are replacing traditional production methods? Before looking at new developments in vaccine manufacturing, it is important to understand the difference between the production of vaccines and other biopharmaceuticals, the risk-safety consideration related to working with pathogens and pathogenic antigens is a key driver. As with all biomolecules purified from crude biological material, the removal of contaminants (eg, derivatives from host cell such as DNA, protein, or leachables), must be documented. However, the removal or inactivation of adventitious viruses remains a unique challenge. Despite the advances in vaccine manufacturing across the globe, regulatory, technical, and manufacturing hurdles remain. Identifying suitable antigens, adjuvants, and delivery methods are important aspects in developing new platforms for vaccine development and production. Public demand for safe and effective vaccines continues.
In addition, regulatory requirements have led to an emphasis on well characterized, safe vaccines. Traditional vaccines are produced; 1. In eggs a. Old and familiar technology that has been practiced for more than 60 years b. Requires a large number of specific pathogen free (SPF) eggs c. Process is labour intensive d. H i g h l y s u s c e p t i b l e t o b a c t e r i a l contamination. e. Individuals who are allergic to eggs might have allergic reactions to such vaccines. 2. In mammalian cells a. Animal cell-culture processes are encouraged by regulatory authorities for reduced uncertainty and puts more controls on process. b. The tumorigenic and oncogenic potential of the cells in which the virus is propagated is major concern c. The use of animal-derived components in the cell-culture media - whether serum-sourced from calf or trypsinsourced from porcine - could be potential sources of animal viruses. The use of recombinant DNA technology (rDNA) like VLPs for the manufacturing of vaccines is becoming more popular. The advantages of an rDNA vaccine platform
VLP's virus-like qualities activate the immune system to stimulate both antibody B-cell and cellular T-cell responses. Once injected into the body, VLPs trigger a specific and targeted immune response against the VLP thereby generating a strong response and protection against the disease. Also, since there is no genetic material (DNA or RNA) in these VLPs, it is impossible for them to infect host cells and, therefore, present no threat of infection to a person being vaccinated, unlike other vaccines which are developed based on the viruses which can replicate in human body thereby causing disease by the vaccine itself. Our recombinant VLP 10 ď‚ƒOctober 2016
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