ArticleBioengineering (Basel, Switzerland)2022
Challenges and Strategies for a Thorough Characterization of Antibody Acidic Charge Variants.
Article in Bioengineering (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 19 citations in OpenAlex.
- Article
- Optimized iCIEF Fractionation Enables Deep Profiling of Antibody Drug Conjugate Charge Heterogeneity.Electrophoresis · 2026Article
- Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin.Pharmaceutical research · 2026Article
- Multi-column continuous chromatography effectively improves the robustness of bind-elute mode chromatography in which a pre-elution wash is applied to reduce weakly bound impurities and charge variants.Journal of biological methods · 2025Article
- Combination of On-Line and Off-Line Two-Dimensional Liquid Chromatography-Mass Spectrometry for Comprehensive Characterization of mAb Charge Variants and Precise Instructions for Rapid Process Development.International journal of molecular sciences · 2023Article
- Expanding the Analytical Toolbox: Developing New Lys-C Peptide Mapping Methods with Minimized Assay-Induced Artifacts to Fully Characterize Antibodies.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Review
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Authors and funding
11 authors.
Funding
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Abstract
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 biotherapeutics. Past characterization studies for basic and acidic variants revealed that full characterizations were limited to the basic charge variants, while the quantitative measurements of acidic variants left gaps. Consequently, the characterization and quantitation of acidic variants are more challenging. A case study of a therapeutic mAb1 accounted for two-thirds of the enriched acidic variants in the initial characterization study. This led to additional investigations, closing the quantification gaps of mAb1 acidic variants. This work demonstrates that a well-designed study with the right choices of analytical methods can play a key role in characterization studies. Thus, the updated strategies for more complete antibody charge variant characterization are recommended.
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