USP offers solutions to evaluate the quality attributes of monoclonal antibodies (mAbs) for therapeutic use. The validated methods that are described in USP–NF General Chapter <129> Analytical Procedures For Recombinant Therapeutic Monoclonal Antibodies include purity determination by size-exclusion chromatography, capillary electrophoresis, and analysis of glycans. In addition to these methods, this webinar will cover analytical procedures for mAbs using SEC-UHPLC and its inclusion in USP <129>. The development of mAbs is also marked by impurities such as host-cell proteins and residual DNA and this webinar will present USP solutions to detect process-related impurities. The use of Multi-Attribute Method (MAM) for analytical testing of mAbs will also be discussed. Lastly, the applications of these analytical methods will be demonstrated through case studies highlighting USP Reference Standards.

Topics:
– Procedures used for evaluation of quality attributes of therapeutic monoclonal antibodies included in USP <129> and other chapters.
– USP solutions for the detection of product- and process-related impurities for mAbs.
– USP Reference Standards and materials used to assess system suitability, or as a tool for analytical method development.

Subject area:
Biologics

Objectives (If applicable):
N/a

Target Audience (If applicable):
– QA/QC analysts
– R&D scientists and managers
– Manufacturing scientists and managers
– Biochemists
– Contract research/manufacturing organizations
– Regulatory professionals