PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the comp

About the Author

Dr. Cenk Undey joined Process Development at Amgen in 2003, where he currently leads the Process and Systems Analysis in Global Process Engineering & Product Engineering group. His division is responsible for providing data management across product lifecycles, developing and deploying advanced real-time multivariate monitoring and control technologies, supporting process monitoring programs and systems, conducting manufacturing process analysis via advanced data analytical methods, and applying systems theory for process troubleshooting and optimization. He led the development and implementation of Multivariate Data Analysis and Real-time Multivariate Statistical Process Monitoring technology in cGMP for use in manufacturing floor during his tenure at Amgen, resulting in significant process improvements. Dr. Undey has industrial experience with PAT tools currently in use in bio/pharmaceuticals manufacturing and is on the steering committee of Pharmaceutical Process Analytics Roundtable. He holds B.Sc., M.Sc. and Ph.D. degrees in Chemical Engineering from Istanbul University, Turkey, and conducted postdoctoral research in Process Modeling, Monitoring and Control group in the Department of Chemical and Biological Engineering at Illinois Institute of Technology, Chicago, USA.

Dr. Duncan Low joined the Process Development Department at Amgen in 2003, where he is currently responsible for Materials Science. He leads cross-functional teams for materials and technology evaluation, technology development, and Process Analytical Technology. He is a member of the ISPE Executive Committee for PAT, is a member of USP's Committee of Experts, and chairs the ASTM E55.01 subcommittee which develops consensus standards for Manufacturers of Pharmaceutical Products. Prior to joining Amgen, he held VP positions at Millipore and Pharmacia Biotech. He has extensive experience of the tools currently in use for upstream and downstream