Challenges in process control for continuous processing for production of monoclonal antibody products

Anurag S Rathore¹,Saxena Nikita¹,Garima Thakur¹,Navnath Deore²

Department of Chemical Engineering, Indian Institute of Technology Delhi, India.

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 article presents a perspective on the challenges that are faced while developing and implementing a robust and adaptable automated control system for continuous biopharmaceutical processes. Potential solutions are presented together with gaps that have been identified.