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Vaccine Manufacturing

Vaccine Manufacturing. Joe Bielitzki NanoScience Technology Center University of Central Florida Orlando, Florida jbielitz@mail.ucf.edu. Vaccine need. Infectious diseases of public health interest Rotavirus Measles, mumps, rubella Diphtheria, pertussis, tetanus Polio Emerging diseases

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Vaccine Manufacturing

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  1. Vaccine Manufacturing Joe Bielitzki NanoScience Technology Center University of Central Florida Orlando, Florida jbielitz@mail.ucf.edu

  2. Vaccine need • Infectious diseases of public health interest • Rotavirus • Measles, mumps, rubella • Diphtheria, pertussis, tetanus • Polio • Emerging diseases • HIV • SARS • WNV • Bio-threat agents • Smallpox • Anthrax • Plague • Infectious diseases of regional concern • Tick borne encephalitis • Japanese encephalitis • Infectious diseases of concern to the military • Dengue • Malaria • Adenovirus • Agriculture (animal vaccines) And some live in all categories

  3. Current status • For the usual products-supply and demand • For the others – wait and see • Discovery through Commercialization • Not linked • Production is limited • Single or limited methodology • cGMP • Little innovation • Market forces restrict change • Intellectual property law • Regulatory process

  4. What’s needed • New technology? • New science? • Incorporation of existing methods? • Flexibility? • Modularity? • Surge capacity? • Interdisciplinary approach? • Research?

  5. Vaccine shortages 2000-2002 • DTaP • Two producers stop • Thimerosal removal • Td • One producer stops • MMR • Sole producer has GMP issues • Varicella • Alteration to production facilities • Pneumococcus • Demand exceeds supply • Influenza • Difficulty growing virus • Increased demand due to change in target population age -65 to 50 • QC issues at one producer

  6. Barriers to vaccine supplies • Exit and concentration (multinationals) • Loss of current producers • mergers • Research and development • Return on investment • IP • Barriers to entry • Cost of trials • Discovery firms are small • Regulation • Need updating • Cost benefit is questioned • Undervaluation of vaccines • Return on investment • Capacity prior to license • Prophylaxis vs therapy

  7. Vaccine production:an interdisciplinary problem • Bringing new science to the table • Adjuvants • Protein stability • Linked development schemes • Pathways to immunity • Looking at production • Immunogen production • Permissive cells • Contamination/cross contamination • Protein stabilization • A systems problem without a systems approach • Entrenched production methods • Shelf life – wet vs dry – refrigerated vs ambient • Benefits for the future • Improved immunity • Increased surge capacity • Ability to deal with novel and new threats • Changing paradigms for an uncertain future

  8. Engineering and Sciencejoin forces • Science needs in vaccine production • Pathways to immunity • Rapid id of immunogenic areas • Adjuvants (MyD88, IMD, RIP/FADD) • Selective T and B cell responses • Rate limiting factors in vaccine utility • New production tools and methods • Immunogen production • Protein stability • Shelf life • Storage requirements

  9. The problem • Vaccine production is slow • Vaccine manufacturing facilities deal with one familiar agent • Lack modularity and flexibility • Methods are validated and approved • Economics limits new methodology

  10. A systems approach • Identify rate limiting steps in process • Technology bottlenecks • Science bottlenecks • Define an ideal vaccine response • Reverse engineer the process • Immunology • Host and agent needs • Manufacturing needs • Storage and shelf life • Time to product • What do we know and what do we need to know • Who knows what now

  11. A team of scientistsa fresh look • Immunologist • Microbiologist • Vaccinologist • Systems engineer • Bio Process engineer • Generalist

  12. Study concepts • Report on the status of research for advancing the vaccine manufacturing • Current production methods and needs • Innovative concepts • Research needs to facilitate flexibility • Research needs to increase surge capacity • Research needs for modularity (plug and play) • Vaccine short comings (as a Product) The Pharmaceutical JournalVol 275 No 7373 p543-54429 October 2005

  13. Recent IOM Publications • Financing Vaccines in the 21st Century (2003) • Assuring Access and Availability • Orphans and Incentives (1997) • Developing Technologies to Address Emerging Infections • Biological Threats and Terrorism (2002) • Assessing the Science and Response Capabilities • there are more Recent Non-IOM publication Vaccines: Frontiers in Design and Development (2005) Moingeon, P.

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