Join USP and industry scientific experts to learn about USP’s efforts to build novel standards to support multi-attribute methods (MAM) for biologics. This work was initiated following feedback from stakeholders who attended USP’s first Biologics Stakeholder Forum in 2020. The Biologics Stakeholder Forum series was created to explore industry’s most pressing challenges at the interface of biotherapeutic quality and innovation.
This Open Forum will include presentations by USP scientists and members of the USP MAM Expert Panel that was created in 2020. The Open Forum will also allow time for questions and comments from the audience to help shape these new standards prior to publication in the Pharmacopeial Forum or release to the market. Participants will:
- Learn about the purpose, scope, and content of a new informational general chapter on mass spectrometry-based MAM.
- Hear about MAM-based analysis of USP mAb reference standards and considerations to enhance robustness of sample preparation.
- Understand USP’s plans for future Forums and topics
Who should participate?
- Subject matter experts in MAM
- Biologics manufacturers
- Contract research organizations
Will be posted upon completion.
- USP Welcome and Opening Remarks, Fouad Atouf, Ph.D.
- 2020 Stakeholder Forum Overview and USP Multi-Attribute Method Expert Panel, Edward Chess, Ph.D.
- Update on MAM Laboratory Studies and Future Plans, Diane McCarthy, Ph.D.
Please contact Jacqueline Starkes for more information