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Challenges and Strategies for a Thorough Characterization of Antibody Acidic Charge Variants

3 Nov 2022

Abstract excerpt

Heterogeneity of therapeutic Monoclonal antibody (mAb) drugs are due to protein variants generated during the manufacturing process. These protein variants can be critical quality attributes (CQAs) depending on their potential impact on drug safety and/or efficacy. To identify CQAs and ensure the drug product qualities, a thorough characterization is required but challenging due to the complex structure of...

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Share to Monoclonal and Polyclonal Antibodies Research
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PMID: 36354552
DOI: 10.3390/bioengineering9110641

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