Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing.

Baker, Elizabeth; Ponder, Jessica; Oberdorfer, Johannes; Spreitzer, Ingo; Bolden, Jay; Marius, Marine; Bonnevay, Thierry; Sullivan, Kristie

Baker, Elizabeth; Ponder, Jessica; Oberdorfer, Johannes; Spreitzer, Ingo; Bolden, Jay; Marius, Marine; Bonnevay, Thierry; Sullivan, Kristie.

Afiliación

Baker E; Physicians Committee for Responsible Medicine, Washington, DC, USA.
Ponder J; Physicians Committee for Responsible Medicine, Washington, DC, USA.
Oberdorfer J; Rapid Micro Biosystems Europe GmbH, Munich, Germany.
Spreitzer I; Paul Ehrlich Institute, Langen, Germany.
Bolden J; Eli Lilly, Indianapolis, IN, USA.
Marius M; Analytical Sciences, Sanofi Vaccines, Lyon, France.
Bonnevay T; Analytical Sciences, Sanofi Vaccines, Lyon, France.
Sullivan K; Physicians Committee for Responsible Medicine, Washington, DC, USA.

Altern Lab Anim ; 51(6): 401-410, 2023 Nov.

Article en En | MEDLINE | ID: mdl-37855095

Asunto(s)

Pirógenos; Vacunas; Animales; Humanos; Seguridad de Equipos; Endotoxinas/metabolismo; Cangrejos Herradura/metabolismo; Vacunas/metabolismo; Prueba de Limulus/métodos

Palabras clave

bacterial endotoxins; endotoxin; limulus; limulus amoebocyte lysate; pyrogen; recombinant Cascade Reagent; recombinant Factor C; recombinant bacterial endotoxins test

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirógenos / Vacunas Límite: Animals / Humans Idioma: En Revista: Altern Lab Anim Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

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