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Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop

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Book Information
Edition:	1st
Publisher:	National Academies Press
ISBN:	0-309-15322-0 (0309153220)
ISBN-13:	978-0-309-15322-5 (9780309153225)
Binding:	E E Book + ProQuest Ebook Central
Copyright:	2010
Publish Date:	07/10
Weight:	0.00 Lbs.
Subject Class:	PUB (Public Health)
Return Policy:	Non-Returnable.

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Class Specifications
Discipline:	Micro/Immuno
Subject Definition:	Vaccines; Vaccination; Biological Warfare-Prevent & Control
NLM Class:	QW 805
LC Class:	KF27
Abstract:	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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