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Influenza Vaccine Manufacturing: Can New Technologies Open the Production Bottleneck?

Decision Resources, Inc., April 2010, Pages: 27


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With the threat of swine flu in 2009 came vaccine shortages, long lines at distribution centers, and frustrated consumers. New technologies for manufacturing flu vaccines could increase the speed and efficiency of producing vaccines and help to avoid these problems. The European Commission’s approval of Novartis’s Optaflu in 2007 was a significant step forward for cell-based production methods, and many competitors are jumping into the race to develop the next generation of influenza vaccines.

Questions answered in this report:

- Pandemic influenza threats and outbreaks have had a dramatic impact on the overall influenza vaccine market. What fundamental changes to the dynamics of the marketplace occurred as a result of the H5N1 avian influenza threat? How did governments respond to the 2009 A/H1N1 pandemic? How did this outbreak affect vaccine manufacturers?

- The manufacture of influenza vaccines is based on antiquated methods initially developed in the 1940s. What new methods are being implemented to increase the efficiency and speed of manufacturing influenza vaccine? Which companies are leading this trend?

- The drive to create new manufacturing methods is prompting innovative development efforts throughout the industry. What cutting-edge technologies are most advanced in development? Which companies are investing in and developing these technologies?

- Collaboration among pharmaceutical companies and biotech companies as well as government support and participation are key to accelerating the development of new vaccine manufacturing technologies. Which companies are involved in influenza-vaccine-related dealmaking? How is the U.S. government promoting and supporting influenza vaccine development?

Scope of the report:

Influenza disease and prevention: Occurrence and impact of seasonal and pandemic influenza infections, emerging pandemics, the threat and impact of the H5N1 avian flu virus.

The 2009 A/H1N1 pandemic: Threat, spread, and results of 2009 A/H1N1 infections, government response, vaccine approvals.

Impact of 2009 A/H1N1: Vaccine shortages and surpluses, financial impact on vaccine manufacturers, Decision Resources’ Pharmaview historical sales data and forecast for influenza vaccines.

Egg-based manufacturing methods: Strain identification, seed production, production methods, drawbacks.

Mammalian-cell-based methods: Production processes, cell lines, Novartis, Baxter International, Solvay Pharmaceuticals, Crucell.

Emerging technologies: Baculovirus production systems, recombinant antigens, virus-like particles, toll-like-receptor-based platform, universal vaccines, DNA vaccines, Protein Sciences, Novavax, VaxInnate, Dynavax, Vical.

Outlook for influenza vaccine manufacturing: Impact of drawbacks on current methods, promotion and development of cell-based methods, adjuvants, emerging markets.



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