Institute for International Research

IBC's 13th International Process Validation for Biopharmaceuticals was one of 5 conferences that took place during Biopharmaceutical Development & Production Week which took place on March 2-6, 2009 in Carlsbad, CA.

By providing a strong emphasis on Quality by Design, Design of Experiments and process understanding, this year's conference allowed attendees to learn how to apply new approaches to process validation in order to establish best practices that could be immediately implemented at their organizations. Attendees gathered at this year's conference to:

• Hear current approaches to assess risk and minimize the amount of time spent and energy exerted when performing validation while still maintaining regulatory compliance
• Discover how to successfully lower manufacturing costs by focusing on process research and the continuous implementation of improvements

Conference Highlights Included:

Keynote Presentation:

Critical Quality Attributes: The Foundation of QbD and Process Validation
Ron Taticek, Ph.D.
Director, CMC Regulatory Affairs
Genentech, Inc.

Featured Session:
Continuous Improvement in the Low Cost Manufacturing of Bovine Somatotropin
Brad Storrs, Ph.D., Senior Fellow and Bioprocess Technology Lead, Monsanto Company

Session Topics Covered:

• Assessing the Most Effective Approaches to Process Validation
• Designing Effective Experiments in the New Era of Process Validation
• Advantages, Challenges and Obstacles of Quality by Design Implementation
• New and Emerging Process Validation Challenges

This conference was conveniently co-located with Technology Transfer and Outsourcing Manufacturing of Biopharmaceuticals giving attendees access to these additional conferences and networking in the shared exhibit hall which featured over 33 booths.

Planning is now underway for Biopharmaceutical Development & Production week 2010 which will return to the La Costa Resort and Spa on March 1-5, 2010. Join the Process Validation for Biopharmacetuicals priority contact list for latest updates on this conference for 2010!