As process characterization and process understanding methods have advanced, it has become statistically apparent that raw materials can be a major source of variability, affecting development and manufacturing.
Attend this conference to learn about:
- Strategies to develop a comprehensive raw material variability testing, characterization and control plan
- Risk-mitigation in media/feed change, hydrolysates and other upstream operations
- Chromatography resins, adsorbent lot variability and other downstream challenges
- Developing a raw material control strategy for use at multiple manufacturing sites
- Mitigating risk of raw material contamination by adventitious agents
- Strategies to ensure safety and reliability of supplier-derived raw materials
Featured Presentations
Matt Osborne, Ph.D.
Cell Culture Technical Lead
Eli Lilly S.A., Ireland
Kimberly Carnes
Manager, Quality Assurance Compliance
Human Genome Sciences, Inc.
Victor J. Melendez Colon, Ph.D.
Principal Scientist, Process Development
Amgen Manufacturing, Limited, Puerto Rico
Abdul Wajid, Ph.D.
Senior Director, Process Sciences
XOMA (US) LLC