Influenza Vaccine Manufacturing-Abstract

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					                                                                               A Service of Decision Resources

      Discovery and Innovation: Technologies, Strategies, and Dealmaking
                Barbara M. Bolten, M.S., M.B.A., Senior Program Manager

      Influenza Vaccine Manufacturing: Can New
      Technologies Open the Production Bottleneck?
      Barbara M. Bolten, M.S., M.B.A.
      Decision Resources

  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 produc-
  ing 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 mar-
      ket. 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 pro-
      moting and supporting influenza vaccine development?

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      • 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 manufac-
        turers, Decision Resources’ Pharmaview historical sales data and forecast for influenza vaccines.
      • Egg-based manufacturing methods: Strain identification, seed production, production methods,
      • 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, promo-
        tion and development of cell-based methods, adjuvants, emerging markets.

    Mentioned in This Report:
      •   Abbott Laboratories              •   ID Biomedical                    •   Select Vaccines
      •   Antigen Express                  •   Immune Targeting Systems         •   ShanH
      •   AstraZeneca                      •   Inovio Biomedical                •   Shantha Biotechnics
      •   Avimex Laboratories              •   Intercell                        •   Shenzen Neptunus Interlong
      •   Baxter International             •   Isconova                             Biotechnique
      •   Bharat Biotech                   •   Johnson & Johnson                •   Sinovac Biotech
      •   Biological E                     •   Juvaris BioTherapeutics          •   Solvay Biologicals
      •   Cadila Pharmaceuticals           •   Lentigen                         •   Solvay Pharmaceuticals
      •   Chiron                           •   MedImmune (AstraZeneca           •   TechnoVax
      •   CPL Biologicals                      subsidiary)                      •   Theraclone Sciences
      •   Crucell                          •   Merck & Co.                      •   UMN Pharma
      •   CSL Biotherapies                 •   Merieux Alliance                 •   Vaxart
      •   Dynavax Technologies             •   Mucosis                          •   Vaxine
      •   DynPort Vaccine Company          •   NanoBio                          •   VaxInnate
      •   Eurocine Vaccines                •   Neugenesis                       •   Vical
      •   FluGen                           •   Novartis                         •   ViraBiotech
      •   Folia Biotech                    •   Novavax                          •   Vivaldi Biosciences
      •   GE Healthcare                    •   PaxVax                           •   Vivalis
      •   Generex Biotechnology            •   Protein Sciences                 •   Xcellerex
      •   GlaxoSmithKline                  •   Roche                            •   Zhejiang Tianyuan
      •   GlobeImmune                      •   Sanofi Pasteur                        BioPharmaceuticals
      •   iBioPharma                       •   Sanofi-Aventis

    Key Terms for This Report:
    A/H1N1, Baculovirus, Cell-based, Celvapan, Crucell, Dynavax, Influenza, Novavax, Optaflu,
    Pandemic, Protein Sciences, Swine flu, Universal vaccine, Vaccine, VaxInnate

Decision Resources                                                                                          3-2
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Decision Resources                                                                              3-3

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