Validation Of Integrated Cryogenic Systems For Cell Therapy Manufacturing

Amittha Wickrema, PhD* presented this case study at a virtual meeting hosted by Cytiva in March 2021. The event brought industry and academic leaders together to discuss flexible, automated, and integrated solutions that can lead the way to a sustainable cryogenic cold chain ecosystem.

Here, Dr. Wickrema reviews his experience in selecting and implementing instruments for a new facility dedicated to cell and gene therapies. He describes how to validate instruments to ensure a functional cryogenic cold chain is achieved and provides insight into the activities of the David and Etta Jonas Center for Cellular Therapy, Advanced Cellular Therapeutics Facility, University of Chicago. This facility manufactures cellular therapy products in-house, serving internal cellular therapy program needs and producing approximately 400 cellular therapy products each year.

*Amittha Wickrema, PhD is the Director of the Advanced Cellular Therapeutics Facility and Faculty Director of the Dept. of Medicine at the University of Chicago.