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

Notice
This publication has been discontinued on July 17, 2013.

Abstract

Introduction:

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 effi ciency of producing vaccines and help to avoid these problems. The European Commission' s approval of Novartis' s Optaflu in 2007 was a signifi cant 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 effi ciency 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:

  • 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, fi nancial impact on vaccine manufacturers, Decision Resources' Pharmaview historical sales data and forecast for influenza vaccines.
  • Egg-based manufacturing methods: Strain identifi cation, 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.

Mentioned in This Report:

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

“Recent flu vaccine shortages brought the drawbacks of current production methods into sharp relief. Suppliers need to act quickly to develop better systems that can be scaled up rapidly enough to meet the demands of a potentially virulent pandemic. Development of a universal flu vaccine would revolutionize the fi eld.” -Barbara M. Bolten, M.S., M.B.A., Senior Program Manager, Decision Resources.

Table of Contents

  • Executive Summary
    • Strategic Considerations
    • Stakeholder Implications
  • Introduction
  • Influenza Virus and Disease
  • Prevention of Influenza
  • The Threat and Impact of Pandemic Influenza
    • Emerging Pandemics: Threats and Readiness
    • The H5N1 Threat
    • Impact of the 2009 A/H1N1 Pandemic
  • Egg-Based Methods of Producing Influenza Vaccine
  • Mammalian-Cell-Based Methods
    • Novartis
    • Baxter International
    • Solvay Pharmaceuticals
    • Crucell
  • Emerging Technologies
    • Protein Sciences
    • Novavax
    • VaxInnate
    • Dynavax Technologies
    • Vical
  • Outlook for Influenza Vaccine Manufacturing

Tables

  • 1. Select Approved Seasonal Influenza Vaccines
  • 2. 2009 A/H1N1 Vaccine Ingredient Orders by the U.S. Department of Health and Human Services, May-July 2009
  • 3. Select Influenza-Vaccine-Related Deals
  • 4. U.S. Department of Health and Human Services Grants to Companies for the Development of Cell-Based Influenza Vaccines
  • 5. Select Companies with Influenza Vaccine Technology or Products

Figures

  • 1. Influenza Virus Structure Schematic
  • 2. Seasonal vs. Pandemic Influenza
  • 3. Worldwide Sales of Seasonal and Pandemic Influenza Vaccines, 2001-2016
  • 4. Creation of Influenza Vaccine Viral Strains Using Reassortment
  • 5. Creation of Influenza Vaccine Viral Strains Using Reverse Genetics
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