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Biopharmaceutical Raw Materials throughout the Product Lifecycle

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Strategies to Identify, Test, Control and Mitigate Risk of Raw Material Variability in Upstream/Downstream Development and Clinical/Commercial Manufacturing

Alternate Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

February 27 - 28, 2012 · Hilton San Diego Bayfront Hotel · San Diego, CA

Event Overview

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Conference Attendee/Onsite Information such as:
· Conference materials and final agendas · Registration/check in hours · Onsite logistics

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

Development of a Raw Material Control Strategy for Use at Multiple Manufacturing Sites
Matt Osborne, Ph.D.
Cell Culture Technical Lead
Eli Lilly S.A., Ireland

Quality Management Best Practices in the Raw Material Supply Chain
Kimberly Carnes
Manager, Quality Assurance Compliance
Human Genome Sciences, Inc.

Strategies to Reduce Production Disturbances and Performance Variability Introduced by Raw Materials used in Product Manufacturing Operations
Victor J. Melendez Colon, Ph.D.
Principal Scientist, Process Development
Amgen Manufacturing, Limited, Puerto Rico

Assessment of Variability in Upstream Media and Feed Change and its Impact on Antibody Cell Line Performance and Quality Attributes
Abdul Wajid, Ph.D.
Senior Director, Process Sciences
XOMA (US) LLC