Characterization and Comparability of Complex Biologics

5th International Meeting

December 8-10, 2008
Baltimore, Maryland

Topics:

• Analytical Bridging Between Phases
• Functional Assays to Determine Effect of Biochemical / Biophysical Changes
• Product Comparability Assessments
• In-Process Monitoring
• Product Characterization Precedence
• Process Change Implementation
• Clinical Validation
• Rapid Analysis and Screening
• Documentation and Regulatory Submissions
• Trends in Biological Comparability
• Unique Challenges with Cellular and Viral Products
• Risk Assessment and Management

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John Hennessey, Ph.D. - Merck & Company, Inc.

Please contact our Sales Department to become a sponsor.

Of particular interest will be the developments in rapid analytical methods and in-process monitoring. We’ll also evaluate the progress that is being made in validating product comparability for a number of product types, including the clinical methodologies that are providing the most meaningful results. To support the actual data, we will cover the more effective documentation and regulatory submission approaches that have been used to show comparability for established products. Finally, we will have exhibits and workshops from the industry’s leading technology suppliers so that the latest analytical tools and capabilities can be evaluated.

Please join us as we analyze the issues relating to the characterization of complex biologicals and explore the problems associated with establishing biological product comparability. Our primary focus will be on the more complex products such as cellular and viral therapeutics, where the more difficult challenges lie and the most comprehensive understanding of the concepts can be developed. To explore the realm of analytical capabilities that will be needed, we will build on the data and techniques that have been established for recombinant proteins and antibodies, but then extrapolate these means as we attempt to define what can work in the most difficult applications.

Details for accommodations are forthcoming.
Please contact WilBio if you have any questions.

P.O. Box 1229, Virginia Beach, VA 23451
Phone: (757) 423-8823 • Fax: (757) 423-2065 • Email:info@wilbio.com