USP Reference Standard Monoclonal Antibodies: Tools to Verify Glycan Structure

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.