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- W2566446181 abstract "This chapter discusses the multiple posttranslational and chemical heterogeneities that may arise within recombinant antibodies and possible consequences for mechanisms of action in vivo. Structural and functional diversity may be illustrated by the ubiquitous and dynamic posttranslational modifications (PTM) of phosphorylation and dephosphorylation. The clinical efficacy of recombinant antibody therapeutics has resulted in their worldwide adoption as drugs of choice, for example, in oncology and inflammation. In addition to the demonstration of clinical efficacy, an innovator company seeking approval for a potential protein therapeutic is required to characterize the drug product, functionally and structurally, employing multiple orthogonal analytical technologies. The parameters established define the drug substance, and/or drug product, and must be maintained throughout the lifetime of the drug. In the process, critical quality attributes (CQAs) are identified that contribute to drug efficacy and are achieved employing quality by design (QbD) parameters unique to the production platform and downstream protocols employed." @default.
- W2566446181 created "2017-01-06" @default.
- W2566446181 creator A5086098057 @default.
- W2566446181 date "2016-12-01" @default.
- W2566446181 modified "2023-09-26" @default.
- W2566446181 title "Antibody Posttranslational Modifications" @default.
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