Medicine
Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches
Summary of a Workshop
by Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, Rapporteurs; Board on Life Sciences; Division on Earth and Life Studies; National Research Council
Description
A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure--currently defined as enough material to treat or vaccinate 3 million personnel--within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014. The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"--repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.
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http://www.nap.edu/12899
National Academies Press
The National Academies Press (NAP) publish the reports of the National Academies of Sciences, Engineering and Medicine. They published more than 200 books a year on a wide range of topics.
View all titlesBibliographic Information
- Publisher National Academies Press
- Publication Date July 2010
- Orginal LanguageEnglish
- ISBN/Identifier 9780309153218
- Publication Country or regionUnited States
- FormatPaperback
- Primary Price 15 USD
- Pages38
- ReadershipProfessional and scholarly
- Publish StatusPublished
- Dimensions11 x 8.5 inches
- Biblio NotesRelated Digital edition - 9780309153225 . Copyright year 2010.
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