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Therapeutic antibody glycosylation analysis: a contract research organization perspective in the frame of batch release or comparability support.

Authors
  • Delobel, Arnaud
  • Cantais, Fabrice
  • Catrain, Anicet
  • Dereux, Erell
  • Van Vyncht, Géry
Type
Published Article
Journal
Methods in Molecular Biology
Publication Date
Jan 01, 2013
Volume
988
Pages
115–143
Identifiers
DOI: 10.1007/978-1-62703-327-5_8
PMID: 23475717
Source
Medline
License
Unknown

Abstract

Glycosylation of the Fc moiety of a monoclonal antibody is a heterogeneous posttranslational process considered as a critical quality attribute of the purified drug substance due to its major impact on safety and efficacy (i.e., immunogenicity, CDC or ADCC effector functions, etc.). Glycosylation should thus be addressed for batch-to-batch comparability and for drug substance characterization, in terms of identity and/or purity testing. We present below a set of efficient, performing and complementary analytical tests that can be used alone or in combination, depending on the information needed and available laboratory instrumentation. The results obtained using these techniques for "global" glycosylation profile, N-glycans profiling, monosaccharides, and sialic acids determination are presented for the Trastuzumab (Herceptin)-humanized mAb produced in CHO.

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