Time: 9:00 am–5:00 pm (PST)
Join industry, regulatory and scientific experts at the inaugural USP Biologics Stakeholder Forum. Exploring industry's most pressing challenges at the interface of biotherapeutic quality and innovation, each meeting of this Forum series will focus on a single area of biotherapeutic quality that can be advanced through collaborations with USP – an independent scientific organization that develops quality standards used globally by industry.
This inaugural Forum presents an opportunity to engage with industry leaders, FDA and USP to help shape the development of quality standards for biotherapeutic processes and products.
- Explore the application of new test methodologies such as the multi-attribute method (MAM) to generate more detailed information about critical quality attributes of complex biologics.
- Discuss challenges around implementing new test methodologies and approaches in a GMP environment.
- Identify standards that might support these innovative approaches supporting quality and efficient testing.
USP Today: Standards for Biopharmaceutical Innovation
Ronald T. Piervincenzi, Ph.D., Chief Executive Officer, USP
- USP's focus on quality standards for method and process performance during biopharmaceutical innovation
- Use of MAM to enhance biotherapeutic process and product knowledge
- Case studies illustrating the development and application of MAM in characterization of biologics and opportunities for release testing
- Quality considerations for MAM
- USP's efforts to develop quality standards to support MAM and mass spectrometry
12601 Twinbrook Parkway
Rockville, MD 20852
Stakeholder Forum Summary
- 1. USP Today: Standards for Biopharmaceutical Innovation, USP, Ronald T. Piervincenzi
- 2. USP Biologics Strategy, USP, Fouad Atouf
- 3. Enhancing Biotherapeutic Process and Product Knowledge with the Multi-Attribute Method (MAM) – Pfizer, Andrew Dawdy
- 4. Quality Considerations for the Multi-Attribute Method (MAM), U.S. FDA, Sarah Rogstad
- 5. USP Standards to Support Multi-Attribute Methods (MAM) and Mass Spectrometry, USP, Diane McCarthy