Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches: summary of a workshop
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Washington, D.C.
National Academies Press
c2010
|
| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | 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 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 |
| Beschreibung: | 1 Online-Ressource (xi, 26 p.) |
| ISBN: | 0309153220 1282660438 9780309153225 9781282660434 |
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| 245 | 1 | 0 | |a Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches |b summary of a workshop |c 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 |
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| 500 | |a 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 | ||
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| spelling | 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 Washington, D.C. National Academies Press c2010 1 Online-Ressource (xi, 26 p.) txt rdacontent c rdamedia cr rdacarrier 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 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 Biological Warfare / prevention & control / United States Drug Approval / United States Antibodies, Monoclonal / therapeutic use / United States Vaccines / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Biological warfare / Safety measures fast Drug approval fast Monoclonal antibodies / Therapeutic use fast Vaccines fast Biological warfare United States Safety measures Monoclonal antibodies Therapeutic use Drug approval United States Vaccines United States USA 1\p (DE-588)1071861417 Konferenzschrift gnd-content Fox, Jeffrey Sonstige oth Shelton-Davenport, Marilee Sonstige oth Hook-Barnard, India Sonstige oth National Research Council (U.S.) Standing Committee on Biodefense at the U.S. Department of Defense Sonstige oth National Research Council (U.S.) Board on Life Sciences Sonstige oth Erscheint auch als Druck-Ausgabe, Paperback 0-309-15321-2 Erscheint auch als Druck-Ausgabe, Paperback 978-0-309-15321-8 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=326079 Aggregator Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches summary of a workshop Biological Warfare / prevention & control / United States Drug Approval / United States Antibodies, Monoclonal / therapeutic use / United States Vaccines / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Biological warfare / Safety measures fast Drug approval fast Monoclonal antibodies / Therapeutic use fast Vaccines fast Biological warfare United States Safety measures Monoclonal antibodies Therapeutic use Drug approval United States Vaccines United States |
| subject_GND | (DE-588)1071861417 |
| title | Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches summary of a workshop |
| title_auth | Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches summary of a workshop |
| title_exact_search | Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches summary of a workshop |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches |
| title_sort | considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches summary of a workshop |
| title_sub | summary of a workshop |
| topic | Biological Warfare / prevention & control / United States Drug Approval / United States Antibodies, Monoclonal / therapeutic use / United States Vaccines / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Biological warfare / Safety measures fast Drug approval fast Monoclonal antibodies / Therapeutic use fast Vaccines fast Biological warfare United States Safety measures Monoclonal antibodies Therapeutic use Drug approval United States Vaccines United States |
| topic_facet | Biological Warfare / prevention & control / United States Drug Approval / United States Antibodies, Monoclonal / therapeutic use / United States Vaccines / United States HISTORY / Military / Biological & Chemical Warfare Biological warfare / Safety measures Drug approval Monoclonal antibodies / Therapeutic use Vaccines Biological warfare United States Safety measures Monoclonal antibodies Therapeutic use Drug approval United States Vaccines United States USA Konferenzschrift |
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