Course Description:Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including COVID-19. These complex biologics are recombinantly engineered to specifically bind to unique targets.
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.
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.
“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 be hosted live first so that participants can submit questions to the speaker(s). It will then be available for on-demand viewing.
Upon completion of 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.
Who should participate:
- Lab personnel in research and development, manufacturing and production
- Scientists and managers of manufacturing and contract research organizations
- Quality assurance and quality control specialists and auditors
- Regulatory professionals
Speakers
Dr. Kevin Carrick
Director, USP Global Biologics
Dr. Li JingTeam Lead, Science & Standard Liaison, USP Global Biologics