Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study

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...

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Bibliographic Details
Main Authors: Anushikha Thakur, Rekha Nagpal, Avik Kumar Ghosh, Deepak Gadamshetty, Sirisha Nagapattinam, Malini Subbarao, Shreshtha Rakshit, Sneha Padiyar, Suma Sreenivas, Nagaraja Govindappa, Harish V. Pai, Ramakrishnan Melarkode Subbaraman
Format: Article
Language:English
Published: Nature Portfolio 2021-06-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-021-92338-1

Internet

https://doi.org/10.1038/s41598-021-92338-1

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