Coverart for item
The Resource Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop, Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies

Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop, Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies

Label
Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop
Title
Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches
Title remainder
summary of a workshop
Statement of responsibility
Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies
Contributor
Subject
Genre
Language
eng
Summary
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
Member of
Cataloging source
N$T
Dewey number
358.38
Index
no index present
LC call number
UG447.8
LC item number
.C66 2010eb
Literary form
non fiction
Nature of contents
dictionaries
NLM call number
  • 2010 L-470
  • WA 295
http://library.link/vocab/relatedWorkOrContributorName
  • Fox, Jeffrey
  • Shelton-Davenport, Marilee
  • Hook-Barnard, India
  • National Research Council (U.S.)
  • National Research Council (U.S.)
http://library.link/vocab/subjectName
  • Biological warfare
  • Monoclonal antibodies
  • Drug approval
  • Vaccines
  • Biological Warfare
  • Drug Approval
  • Antibodies, Monoclonal
  • Vaccines
  • United States
  • HISTORY
  • Biological warfare
  • Drug approval
  • Monoclonal antibodies
  • Vaccines
  • United States
Label
Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop, Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies
Instantiates
Publication
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
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
Control code
659579790
Dimensions
unknown
Extent
1 online resource (xi, 26 pages)
File format
unknown
Form of item
online
Isbn
9781282660434
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)659579790
Label
Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop, Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies
Publication
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
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
Control code
659579790
Dimensions
unknown
Extent
1 online resource (xi, 26 pages)
File format
unknown
Form of item
online
Isbn
9781282660434
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)659579790

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