Hear how to develop new chromatographic and non-chromatographic methods to overcome the challenges of large scale protein production. Apply platform approaches for non-platform projects to efficiently develop purification processes for non-antibody drugs. Learn about the successful development of a 2-step purification process for monoclonal antibodies. Evaluate the economical and regulatory impact of sequential multi-column chromatography in downstream processing. Gain insights towards overcoming platform facility fit issues for high titer processes and reconfiguring a commercial biologics facility to a launch facility for new products. Benefit from case studies on the successful development and implementation of single-use processes in downstream processing.

• Alternative Approaches to Overcome Challenges of Large Scale Protein Production
• Implementation of a 2-Step Purification Processes for Monoclonal Antibodies
• Platform Development Approaches for Non-Platform Projects: Processes for Non-Antibody Drugs

Advisory Board

• Edward Cole, Ph.D., Senior Vice President, Protein Development, Genzyme Corporation
• Chris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc.
• Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, Genentech, Inc.
• Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany
• Brian R. Hubbard, Ph.D., Scientific Executive Director, Process and Analytical Sciences, Amgen Inc.
• David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc.
• Charles Schmelzer, Ph.D., Senior Scientist, Late Stage Purification, Genentech, Inc.
• Peter W. Wojciechowski, Director, Process and Analytical CMC, Johnson & Johnson Regenerative Therapeutics
• Paul Wu, Ph.D., Manager of Protein Isolation, Bayer Healthcare

View the Agenda

• Day One - Morning
• Day One - Afternoon
• Day Two - Morning
• Day Two - Afternoon

View the Other Tracks

• Production & Economics of Biopharmaceuticals
• Scaling Up from Bench through Commercialization
• Cell Culture & Upstream Processing