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USP Reference Standard Monoclonal Antibodies: Tools to Verify Glycan Structure.

Jingzhong Guo1, Huiping Tu1, Li Jing1

  • 1Global Biologics, Science Division, United States Pharmacopeia, Rockville, MD 20852, USA.

Pharmaceuticals (Basel, Switzerland)
|March 26, 2022
PubMed
Summary

New USP monoclonal antibody reference standards aid in verifying glycan profiles for pharmaceutical quality control. These standards ensure analytical method suitability and complement existing resources for glycan analysis.

Keywords:
NISTmAbUSPglycan analysismonoclonal antibody

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Glycan profiling is crucial for monoclonal antibody (mAb) drug products due to its physiological impact.
  • Well-characterized reference standards are essential for evaluating and developing glycan profiling techniques.
  • System suitability testing relies on reliable reference materials for accurate glycan analysis.

Purpose of the Study:

  • To introduce and characterize new USP monoclonal antibody reference standards.
  • To provide well-defined glycan profiles for USP mAb 001 RS, USP mAb 002 RS, and USP mAb 003 RS.
  • To assess the utility of these USP mAb reference standards in analytical testing and method validation.

Main Methods:

  • Characterization of glycan profiles for USP mAb reference standards.
  • Comparative analysis of USP mAb reference standards against other available standards, such as NISTmAb.
  • Evaluation of the USP mAb reference standards as tools for verifying glycan structure and system suitability.

Main Results:

  • The USP has established three new monoclonal antibody reference standards (USP mAb 001 RS, USP mAb 002 RS, USP mAb 003 RS).
  • The glycan profiles of these USP standards encompass a diverse range of glycan species.
  • These USP standards complement existing reference materials, offering a broader spectrum for glycan analysis.

Conclusions:

  • The USP mAb reference standards are valuable tools for assessing analytical testing of mAb glycan profiles.
  • These standards can be used to verify glycan structure and ensure the system suitability of analytical methods.
  • The introduction of these standards supports the development and evaluation of future glycan profiling techniques.