Title |
Fc glycans of therapeutic antibodies as critical quality attributes
|
---|---|
Published in |
Glycobiology, August 2015
|
DOI | 10.1093/glycob/cwv065 |
Pubmed ID | |
Authors |
Dietmar Reusch, Max L Tejada |
Abstract |
Critical quality attributes (CQA) are physical, chemical, biological or microbiological properties or characteristics that must be within an appropriate limit, range, or distribution to ensure the desired product quality, safety, and efficacy. For monoclonal antibody therapeutics that rely on Fc-mediated effector function for their clinical activity, the terminal sugars of Fc glycans have been shown to be critical for safety or efficacy. Different glycosylation variants have also been shown to influence the pharmacodynamic and pharmacokinetic behavior while other Fc glycan structural elements may be involved in adverse immune reactions. This review focuses on the role of Fc glycans as CQAs. Fc glycan information from published literature is summarized and evaluated for impact on patient safety, immunogenicity, bioactivity and pharmacodynamics/pharmacokinetics. |
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Demographic breakdown
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Scientists | 7 | 37% |
Practitioners (doctors, other healthcare professionals) | 1 | 5% |
Science communicators (journalists, bloggers, editors) | 1 | 5% |
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Italy | 1 | <1% |
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