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Identification of Mouse and Human Antibody Repertoires by Next-Generation Sequencing
Published on: March 15, 2019
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Micro-Heterogeneity of Antibody Molecules
Yusuke Mimura1, Radka Saldova2,3, Yuka Mimura-Kimura4
1Department of Clinical Research, National Hospital Organization Yamaguchi Ube Medical Center, Ube, Japan. mimura.yusuke.qy@mail.hosp.go.jp.
Experientia Supplementum (2012)
|October 23, 2021
Summary
Therapeutic monoclonal antibodies (mAbs) require comprehensive characterization of post-translational modifications (PTMs) to ensure consistent efficacy and safety. Understanding PTMs is crucial for maintaining critical quality attributes throughout a drug
Area of Science:
- Biopharmaceutical development
- Protein chemistry
- Immunology
Background:
- Therapeutic monoclonal antibodies (mAbs) are vital IgG biopharmaceuticals.
- mAbs undergo post-translational modifications (PTMs) leading to heterogeneity.
- Recombinant mAb production can alter structural fidelity and biological activity.
Purpose of the Study:
- To review common PTMs in mAbs and endogenous IgG.
- To explore the relationship between mAb structural variants and clinical performance.
- To emphasize the importance of PTM characterization for regulatory approval and drug product consistency.
Main Methods:
- Review of current literature on mAb PTMs.
- Analysis of orthogonal analytical technologies for mAb characterization.
- Discussion of quality by design principles for PTM control.
Main Results:
- PTMs, especially glycosylation at Asn297, are critical quality attributes (CQAs) impacting mAb efficacy and safety.
- Mammalian cell-produced mAbs exhibit less heterogeneity than serum-derived IgG.
- Maintaining a consistent PTM profile is essential for drug product lifespan.
Conclusions:
- Comprehensive structural characterization of mAbs, including PTMs, is mandated by regulatory authorities.
- Control of PTMs is key to ensuring the stability, activity, and immunogenicity profile of therapeutic mAbs.
- Understanding PTM-clinical performance relationships is vital for successful biopharmaceutical development.
Keywords:
Critical quality attributesGlycoformsGlycoproteinsOligosaccharidesPosttranslational modificationsRecombinant antibody therapeuticsMore Related Videos
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