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Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /

On September 15, 2008, the National Academies held the workshop "Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches". The workshop was planned and organized by an ad hoc planning committee made up of members of the...

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Автор-организация: National Research Council (U.S.). Standing Committee on Biodefense at the U.S. Department of Defense., National Research Council (U.S.). Board on Life Sciences.
Други автори: Fox, Jeffrey, Shelton-Davenport, Marilee., Hook-Barnard, India.
Формат: Електронна книга
Език: English
Публикувано: Washington, D.C. : National Academies Press, ℗♭2010.
Предмети:
Онлайн достъп: http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=326079
Подобни документи: Print version:: Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches.
Съдържание:
  • Introduction
  • TMTI case for versatile production platforms
  • Discussion of TMTI efforts
  • Platforms for large-scale monoclonal antibody production
  • Presentation by Brian Kelley
  • Presentation by Dane Zabriskie
  • Discussion
  • Suitability of platforms and supply needed
  • Reducing timeline
  • Manufacturing producation capacity
  • Regulatory issues
  • Platforms for vaccine production
  • Presentation by Dave Robinson
  • Discussion
  • Various platforms
  • Manufacturing facilities
  • Regulatory issues
  • Summary of key points.