Wednesday, Oct. 21, 2020 | 11:00 – 11:30 a.m. EST

Join us for a webinar to learn about how USP mAb reference standards can help developers and manufacturers support the quality of their own methods or rapidly adopt a USP method. Data will be shared from the results of recent tests using these reference standards.

MAb proteins require multiple testing methods for complete characterization. These tests can be challenging to develop and validate, requiring significant time and resources to properly establish and maintain.

"What's New in Biologics?" is a new series of USP webinars that shares the knowledge and expertise of world-wide experts on topics that will shape the future of biologics. This event will first be hosted live so that participants can submit questions to the speaker(s). It will then be available for on-demand viewing.

By taking this course, you will be able to:

• Identify USP staff and resources that can support analytical method development and validation for monoclonal antibody and related biologics.

• Standardize common physico-chemical testing, such as intact mass, peptide mapping, charge heterogeneity, size variants, purity, and glycan analyses.

• Identify publicly available biopharmaceutical grade mAb reference standards that support development and characterization of monoclonal antibodies.

For more information on other course offerings:
Email: education@usp.org, Website: education@usp.org

USP Approved Instructor

Dr. Kevin Carrick
Director of Science & Standards in USP’s Global Biologics

Li Jing, Ph.D.
Science & Standards Liaison, Global Biologics

Of possible interest:

Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function

USP General Chapter <1049.1> Design of Stability Studies for Biotechnology Product Development and Lifecycle Management