ArticlePharmaceuticals (Basel, Switzerland)2022
USP Reference Standard Monoclonal Antibodies: Tools to Verify Glycan Structure.
Article in Pharmaceuticals (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The trial behind it
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Who cites it
2 citing papers in PubMed.
- Charge variant analysis of intact monoclonal antibody reference standards using microfluidic capillary zone electrophoresis.Journal of pharmaceutical and biomedical analysis · 2026Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The glycan profile is a critical quality attribute for pharmaceutical monoclonal antibodies due to the potential physiological impact of the glycan composition when used as a drug product. Monoclonal antibody reference standards are useful as system suitability samples for glycan profile testing. The development of future glycan profiling techniques could be better evaluated by testing well-characterized reference standards. The USP has introduced monoclonal antibody reference standards (i.e., USP mAb 001 RS, USP mAb 002 RS, and USP mAb 003 RS) with the glycan profiles reported herein that can be used to assess the analytical testing of monoclonal antibody glycan profiles. Comparison of the USP reference standards to other available reference standards (NISTmAb) is presented. The glycan profile of the USP monoclonal antibody reference standards covers a range of glycan species that complements other available reference standards. The USP mAb reference standards are a valuable tool that can be used to verify the glycan structure and provide the system suitability of analytical methods.
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