PAT Applied in Biopharmaceutical Process Development And Manufacturing

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

• Introduction. Regulatory Perspective of Innovative Process Development Incorporating PAT Tools. ICH QII Guidelines, impact on PAT. Quality-by-Design, Knowledge Management and Continuous Improvement. PAT - Desired State in Biologics Manufacturing. Miniaturization of Measurement Systems and Technology for improved process understanding and rapid screening. Raw Material Characterization via PAT tools. Rapid Microbial Methods and PAT. Glycosylation monitoring for therapeutic protein manufacturing. Real-time Multivariate Process Monitoring, Control and Optimization. First-principles modeling in combination with PAT (improved process understanding). Spectroscopic methods for Biologics manufacturing monitoring and control. On-line HPLC Applications in Cell Culture and in Purification Processes. Process chemometrics, multivariate modeling and analysis. Soft-sensors and their applications in biologics manufacturing. In-line/At-line/On-line Analytics, Sterile Sampling Systems. Drug substance and drug product (incl. lyophilization) PAT tools. Limitations and challenges of current measurement systems in PAT framework. Current state-of-the art in PAT tools for measuring CQAs in near real-time and future research needs. NIH, NFS and NIST Research Directions towards enabling PAT tools for biologics manufacturing end-point monitoring, control and real-time release opportunities. New sensor technologies and its impact on PAT. PAT Business Case Development, Implementation Challenges and Benefits. PAT as a Manufacturing Excellence Contributor, Its Relations to Lean Manufacturing. Future Directions in PAT.