Article
Evaluation of Heavy-Chain C-Terminal Deletion on Product Quality and Pharmacokinetics of Monoclonal Antibodies.
Journal of pharmaceutical sciences - 1 Jul 2016
Jiang Guoying, Yu Christopher, Yadav Daniela B, Hu Zhilan, Amurao Annamarie, Duenas Eileen, Wong Marc, Iverson Mark, Zheng Kai, Lam Xanthe, Chen Jia, Vega Roxanne, Ulufatu Sheila, Leddy Cecilia, Davis Helen, Shen Amy, Wong Pin Y, Harris Reed, Wang Y John, Li Dongwei
Abstract excerpt
Due to their potential influence on stability, pharmacokinetics, and product consistency, antibody charge variants have attracted considerable attention in the biotechnology industry. Subtle to significant differences in the level of charge variants and new charge variants under various cell culture conditions are often observed during routine manufacturing or process changes and pose a challenge when...
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