Explosive Growth in Biologics and Vaccine Production

Biologics and vaccine development and production capacity continues to spur the bulk of major domestic capital investment projects. Over the years, our expertise and dedication to the biologics and vaccine industry has been praised and awarded by many of our clients. As the industry has continued to expand in this direction, FW Biokinetics has been uniquely positioned to respond to the demand. In fact, biologics and vaccine process development has traditionally been considered our strength - our "sweet spot" if you will. We have long been recognized by the industry for our process knowledge and expertise in these areas and have been sought out by industry leaders keen on learning about the latest manufacturing and industry trends.

With regard to vaccines, our process knowledge extends to all areas of production, from traditional vaccine manufacturing methods involving whole cells, detoxification and egg-based processes, to the more recent recombinant DNA and adjuvant/conjugation processes. Historically, traditional approaches to vaccine production (Diphtheria, Tetanus, Pertussis and Influenza) have involved the cultivation of live cultures, bacterial or viral, from which a suitable antigen is isolated, rendered non-infectious or non-toxic, and purified for human inoculation. The upstream cultivation and handling of live pathogens and toxins must, therefore, be performed in accordance with stringent biological containment standards (BL2-LS or BL3-LS). The development of conjugated vaccines and adjuvants, while producing a more effective immune response in the individual, further complicates downstream processing. However, FW Biokinetics is well acquainted with both upstream and downstream aspects of such a process.

FW Biokinetics is the proud Recipient of
MedImmune's H1N1 Vaccine Supplier Recognition Award

However, FW Biokinetics is quick to recognize two recent trends in vaccine development that promise to revolutionize vaccine manufacturing. The first involves replacing the chicken egg with an alternative host system for the production of live or attenuated viruses. Mammalian and insect cells are the likely candidates. This holds the promise of a more rapid vaccine development in response to new pandemic virus strains, such as pandemic flu, and is one approach being pursued and funded by the FDA and WHO. FW Biokinetics has worked with several clients on a confidential basis in the development of scopes of work in response to FDA RFP's involving pandemic flu.

The second trend involves the application of recombinant DNA technology for production of specific antigens, making use of many of the same expression systems which have been successfully employed for recombinant therapeutic protein manufacture (e.g. E. coli plasmid DNA). This offers a two-fold advantage over traditional vaccine production methods. First, the issue of containment may go away if a non-pathogenic organism (E. coli) is employed. Second, unlike conjugated vaccine processes, which involve parallel product streams which must then be combined, the recombinant approach to antigen production is a straight line process. With our wealth of experience in recombinant cell culture processes, FW Biokinetics is well poised to partner in this exciting new area of vaccine manufacturing.

To learn more about how our biologics and vaccine experts can help you with your next vaccine project challenge, click here to contact us.