Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens - Part 2: Optimisation of cell line assays.

Behr-Gross, M-E; Siklodi, B; Le Tallec, D; Halder, M; Manou, I; Sinitskaya, N; Bruckner, L; Dalmadi, B; Kiss, L; Redhead, K

Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens - Part 2: Optimisation of cell line assays.

Behr-Gross, M-E; Siklodi, B; Le Tallec, D; Halder, M; Manou, I; Sinitskaya, N; Bruckner, L; Dalmadi, B; Kiss, L; Redhead, K.

Afiliación

Behr-Gross ME; European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & Healthcare (DBO), Council of Europe, Strasbourg, France.
Siklodi B; Ceva-Phylaxia, Veterinary Biologicals Co. Ltd, Hungary.
Le Tallec D; European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Halder M; European Commission, Joint Research Centre, Via E. Fermi, 2749, 21027 Ispra (VA), Italy.
Manou I; European Partnership for Alternative Approaches to Animal Testing (EPAA), Brussels, Belgium.
Sinitskaya N; European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Bruckner L; CH-3145 Niederscherli, Switzerland.
Dalmadi B; Ceva-Phylaxia, Veterinary Biologicals Co. Ltd, Hungary.
Kiss L; Ceva-Phylaxia, Veterinary Biologicals Co. Ltd, Hungary.
Redhead K; Vaccine & Assay Consultancy, Watford, WD25 0EX, United Kingdom.

Pharmeur Bio Sci Notes ; 2021: 101-156, 2021.

Article en En | MEDLINE | ID: mdl-34078535

Asunto(s)

Clostridium septicum; Animales; Antígenos Bacterianos; Línea Celular; Ratones; Reproducibilidad de los Resultados; Toxoide Tetánico

Palabras clave

Biological Standardisation Programme; Clostridium septicum vaccine; Council of Europe; EDQM; European Partnership for Alternative Approaches to Animal Testing; European Pharmacopoeia; antigenicity testing; cell-based assay; in vitro test; in vivo test; minimum lethal dose; residual toxicity; total combining power; toxicity testing

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Bases de datos: MEDLINE Asunto principal: Clostridium septicum Límite: Animals Idioma: En Revista: Pharmeur Bio Sci Notes Asunto de la revista: FARMACOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Francia

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