Implementation of Process Analytical Technology in Continuous Process Platforms

Anurag S. Rathore, Ph.D.
Chair Professor
Indian Institute of Technology
Department of Chemical Engineering

Seminar Abstract: Continuous processing has been garnering much interest lately for production of biopharmaceutical products. Purported benefits include higher productivity (10-15X), significant shrinkage in facility footprint as well as equipment cost, and improved process control and consistency in product quality. However, industrial implementation remains a non-trivial task due to the significant complexities associated with controlling continuous processes. Real time monitoring of critical quality attributes followed by real time process control while desired, may not be feasible for every attribute and for every unit operation. This talk will present a perspective on the challenges that are faced while developing and implementing a robust and adaptable automated control system for continuous biopharmaceutical processes. Case studies will be presented to illustrate key concepts.

Bio: Anurag S. Rathore is an Institute Chair Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, process analytical technology and quality by design. He has authored more than 600 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of The AAPS Journal and Associate Editor for Journal of Chemical Technology and Biotechnology. He has a Ph.D. in Chemical Engineering from Yale University. Prof. Rathore is presently serving as Dean, Corporate Relations, at IIT Delhi.