Interlaboratory Co-validation of a UPLC-ToF MS MAM Method for Truncations of a Fc Fusion Protein.

Wu, Gang; Yu, Chuanfei; Tong, Qinghe; Wang, Wenbo; Huang, Xi; Li, Hao; Wang, Lan

Wu, Gang; Yu, Chuanfei; Tong, Qinghe; Wang, Wenbo; Huang, Xi; Li, Hao; Wang, Lan.

Afiliação

Wu G; Division of Monoclonal Antibody Product, National Institute for Food and Drug Control, Beijing, China.
Yu C; School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, China.
Tong Q; Division of Monoclonal Antibody Product, National Institute for Food and Drug Control, Beijing, China.
Wang W; Department of Analytical Development, Center for Biologics Development and Manufacturing, Shanghai Hengrui Pharmaceutical Inc., Shanghai, China.
Huang X; Division of Monoclonal Antibody Product, National Institute for Food and Drug Control, Beijing, China.
Li H; Department of Analytical Development, Center for Biologics Development and Manufacturing, Shanghai Hengrui Pharmaceutical Inc., Shanghai, China.
Wang L; Department of Analytical Development, Center for Biologics Development and Manufacturing, Shanghai Hengrui Pharmaceutical Inc., Shanghai, China.

Curr Pharm Biotechnol ; 24(10): 1315-1325, 2023.

Article em En | MEDLINE | ID: mdl-36372921

Assuntos

Produtos Biológicos; Proteínas

Palavras-chave

CQAs; HRMS; Interlaboratory; LCMS; MAM; QC release testing; UPLC-ToF MS; fusion protein; method validation; multi-attribute method; stability; subunit; truncation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Proteínas Idioma: En Revista: Curr Pharm Biotechnol Assunto da revista: BIOTECNOLOGIA / FARMACOLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: China

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