1 / 13

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

winda
Download Presentation

Vaccine Manufacturing

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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.

More Related