TY  - BOOK
AU  - Fox,Jeffrey
AU  - Shelton-Davenport,Marilee
AU  - Hook-Barnard,India
ED  - National Research Council (U.S.).
ED  - National Research Council (U.S.).
TI  - Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches: summary of a workshop 
SN  - 9780309153225
AV  - UG447.8 .C66 2010eb
U1  - 358.38 22
PY  - 2010///
CY  - Washington, D.C.
PB  - National Academies Press
KW  - Biological warfare
KW  - United States
KW  - Safety measures
KW  - Monoclonal antibodies
KW  - Therapeutic use
KW  - Drug approval
KW  - Vaccines
KW  - Biological Warfare
KW  - prevention & control
KW  - Drug Approval
KW  - Antibodies, Monoclonal
KW  - therapeutic use
KW  - Guerre biologique
KW  - États-Unis
KW  - Sécurité
KW  - Mesures
KW  - Anticorps monoclonaux
KW  - Emploi en thérapeutique
KW  - Médicaments
KW  - Autorisation de mise sur le marché
KW  - Vaccins
KW  - HISTORY
KW  - Military
KW  - Biological & Chemical Warfare
KW  - bisacsh
KW  - fast
KW  - Electronic books
KW  - lcgft
N1  - 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
N2  - 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 Standing Committee on Biodefense at the US Department of Defense. The charge to the planning committee was to bring together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the Transformational Medical Technologies Initiative's (TMTI) vision of developing countermeasures within a few months after a biologic-warfare 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. Participants discussed manufacturing-related characteristics of monoclonal antibodies and vaccines. Although the planning committee understood that the TMTI efforts are broader than biologics and that TMTI platform approaches for biologics extend beyond monoclonal antibodies and vaccines, the planning committee believed that focusing on monoclonal antibodies and vaccines could illustrate some of the promise and challenges of platform approaches
UR  - https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=326079
ER  -