The President's Council of Advisors on Science and Technology (PCAST) recently reviewed the response to manufacturing vaccines for the H1N1 pandemic. The group concluded that there are shortcomings in the existing technologies for producing vaccines and the government coudl serve an important role by funding research areas that could provide needed solutions. See in-Pharma Technologist.com.
Key areas where PCAST said the government could help with research funding include:
- Cell-culture based or recombinant DNA based methods of vaccine production to replace eggs
- Development of optimized seed viruses and potency assays, and investigation of the immune response to live attentuated influenza virus (LAIV)
- Backing of clinical trials for LAIV
- Incentives and pathways for development of recombinant DNA technologies - movement of at least 3 recombinant vaccines into proof of concept trials within 3 years
- Increased use of adjuvants by overcoming regulatory barriers with FDA guidance
- Investigation of possible universal flu vaccine to conserved areas of the virus
Certainly, from my selfish perspective, I would like to see more cell culture based production systems and use of more adjuvants. It is two areas where SAFC currently is active in the vaccine market. We support flu production in cell lines like MDCK and EBx. We also operate a CMO business that produces virus and vaccines for clients - for diseases like influenza, AIDs, malaria, and gene therapeutic applications.
We also supply various adjuvants including squalene into final flu vaccine preparations - particularly for European manufacturers who are less restricted on adjuvant use than their US counterparts. SAFC could also play a role in recombinant DNA vaccines in the future I'm certain.
I think the PCAST recommendations make sense. There has been a tremendous resurgence interests in vaccines - see Bill & Melinda Gates Foundation emphasis for example. Vaccines are now being developed for not only the traditional communicable and childhood diseases, but are booming in areas like cancer prevention. The production processes and regulatory processes have not really kept pace. There certainly is a golden opportunity now to upgrade our technoloiges to take advantage of these advances as well as to further advance the field. Government investment in this area should be welcomed and is important to public health.
Posted by Bruce Lehr August 31st 2010.