Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.

Wadhwa, Meenu; Knezevic, Ivana; Kang, Hye-Na; Thorpe, Robin

Wadhwa, Meenu; Knezevic, Ivana; Kang, Hye-Na; Thorpe, Robin.

Afiliación

Wadhwa M; National Institute for Biological Standards and Control (NIBSC), Biotherapeutics Group, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom. Electronic address: Meenu.Wadhwa@nibsc.org.
Knezevic I; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland.
Kang HN; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland.
Thorpe R; 8 Old Forge Close, Welwyn AL6 0SR, United Kingdom.

Biologicals ; 43(5): 298-306, 2015 Sep.

Article en En | MEDLINE | ID: mdl-26144595

Asunto(s)

Productos Biológicos/inmunología; Anticuerpos/análisis; Anticuerpos/inmunología; Industria Farmacéutica; Pruebas de Neutralización

Palabras clave

Assays; Biosimilars; Biotherapeutic products; Immunogenicity assessment; Regulatory evaluation; WHO guidelines

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Productos Biológicos Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2015 Tipo del documento: Article

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