Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /

Mostrar otras versiones (1)

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...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores Corporativos: National Research Council (U.S.). Standing Committee on Biodefense at the U.S. Department of Defense, National Research Council (U.S.). Board on Life Sciences
Otros Autores: Fox, Jeffrey (Jeffrey L.), Shelton-Davenport, Marilee, Hook-Barnard, India
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, ©2010.
Temas:
Biological warfare > United States > Safety measures.
Monoclonal antibodies > Therapeutic use.
Drug approval > United States.
Vaccines > United States.
Vaccines.
Biological Warfare > prevention & control
Drug Approval
Antibodies, Monoclonal > therapeutic use
Vaccines
Guerre biologique > États-Unis > Sécurité > Mesures.
Anticorps monoclonaux > Emploi en thérapeutique.
Médicaments > Autorisation de mise sur le marché > États-Unis.
Vaccins > États-Unis.
Vaccins.
HISTORY > Military > Biological & Chemical Warfare.
Biological warfare > Safety measures
Drug approval
Monoclonal antibodies > Therapeutic use
United States
Acceso en línea:Texto completo
Descripción
Sumario: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
Descripción Física:1 online resource (xi, 26 pages)
ISBN:9780309153225
0309153220
1282660438
9781282660434

Ejemplares similares