Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study
Abstract 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...
Main Authors: | , , , , , , , , , , , |
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Format: | Article |
Language: | English |
Published: |
Nature Publishing Group
2021-06-01
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Series: | Scientific Reports |
Online Access: | https://doi.org/10.1038/s41598-021-92338-1 |