PAT Applied in Biopharmaceutical Process Development And Manufacturing

An Enabling Tool for Quality-by-Design
Herausgeber: Low, Duncan; Undey, Cenk; Menezes, Jose C.

• Gebundenes Buch

Produktbeschreibung

This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control, as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs, and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 328
• Erscheinungstermin: 7. Dezember 2011
• Englisch
• Abmessung: 240mm x 161mm x 22mm
• Gewicht: 660g
• ISBN-13: 9781439829455
• ISBN-10: 1439829454
• Artikelnr.: 30438756

Autorenporträt

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

Inhaltsangabe

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.