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- W2751949649 abstract "Forced degradation studies have become integral to the development of recombinant monoclonal antibody therapeutics by serving a variety of objectives from early stage manufacturability evaluation to supporting comparability assessments both pre- and post- marketing approval. This review summarizes the regulatory guidance scattered throughout different documents to highlight the expectations from various agencies such as the Food and Drug Administration and European Medicines Agency. The various purposes for forced degradation studies, commonly used conditions and the major degradation pathways under each condition are also discussed." @default.
- W2751949649 created "2017-09-15" @default.
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- W2751949649 date "2017-09-21" @default.
- W2751949649 modified "2023-10-13" @default.
- W2751949649 title "Forced degradation of recombinant monoclonal antibodies: A practical guide" @default.
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