Article
Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study.
Scientific reports - 24 Jun 2021
Thakur Anushikha, Nagpal Rekha, Ghosh Avik Kumar, Gadamshetty Deepak, Nagapattinam Sirisha, Subbarao Malini, Rakshit Shreshtha, Padiyar Sneha, Sreenivas Suma, Govindappa Nagaraja, Pai Harish V, Melarkode Subbaraman Ramakrishnan
Abstract excerpt
Sequence variants (SV) in protein bio therapeutics can be categorized as unwanted impurities and may raise serious concerns in efficacy and safety of the product. Early detection of specific sequence modifications, that can result in altered physicochemical and or biological properties, is therefore desirable in product manufacturing. Because of their low abundance, and finite resolving power of conventional...
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