Development and application of potency assays based on genetically modified cells for biological products.

Lei, Yu; Yong, Zhou; Junzhi, Wang

Lei, Yu; Yong, Zhou; Junzhi, Wang.

Afiliación

Lei Y; Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing 100050, China.
Yong Z; Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing 100050, China.
Junzhi W; Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing 100050, China. Electronic address: wangjz@nifdc.org.cn.

J Pharm Biomed Anal ; 230: 115397, 2023 Jun 15.

Article en En | MEDLINE | ID: mdl-37079933

Asunto(s)

Productos Biológicos; Productos Biológicos/farmacología; Factores Biológicos; Control de Calidad; Citocinas; Bioensayo/métodos

Palabras clave

Biological products; Genetically modified cell line; Potency assay; Reporter gene assay

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Tipo de estudio: Prognostic_studies Aspecto: Ethics Idioma: En Revista: J Pharm Biomed Anal Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

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