Characterization and Comparability for Complex Biological Products - November 1-2, 2007

Characterization and Comparability for Complex Biological Products - November 1-2, 2007
The Williamsburg BioProcessing Foundation
The Most Trusted Source of BioProcess TechnologyTM
Characterization and Comparability
for Complex Biological Products
Establishing Methods to Better De? ne Products and Demonstrate Comparability
4th Annual Meeting
November 1-2, 2007
Austin Texas
Please join us as we analyze and advance 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 dif? cult 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 de? ne what can work in the most dif? cult applications.
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.
Topics Include:
? Analytical Techniques
? In-Process Monitoring
? Product Characterization
? Process Change
? Clinical Validation
? Rapid Analysis & Screening
? Regulatory Trends
? Documentation &
Regulatory Submissions
? Trends in Biological
? Unique Challenges with
Cellular & Viral Products
? Risk Assessment &
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