Quality by design for biotechnological products

BIOT 104

Kurt Brorson, kurt.brorson@fda.hhs.gov, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg 64, Rm 1036, 10903 New Hampshire Ave, Silver Spring, MD 20903
Biotechnology products have a number of unique manufacturing and quality challenges, including: complexity of source materials, potential for viral contamination, structural heterogeneities, analytical methodology limitations, uncertainties regarding structure-function relationships, and instability of intermediates and products. The aim of manufacturing process development is to design a manufacturing process that will deliver a high quality product in a consistent and reproducible manner. General regulatory considerations for successful process development and quality by design approaches that address these unique challenges will be discussed.
 

FDA Symposium: Process Analytical Technology (PAT) Initiative
3:00 PM-5:55 PM, Monday, 11 September 2006 Hilton San Francisco -- Plaza, Oral

Division of Biochemical Technology

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006