In this event, speakers share their experiences with case study examples of how implementation of flexible, automated, and integrated solutions is leading the way to a sustainable cryogenic cold chain ecosystem.
Amittha Wickrema, Ph.D., Professor of Medicine, Director, Advanced Cellular Therapeutics Facility, Faculty Director, Cellular & Tissue based Processing cGMP Facility Hematology/Oncology Section, Dept. of Medicine, University of Chicago, reviews the cold chain workflow from start to finish for a cellular therapy product.
Wickrema also provides a brief overview of how to validate a cryochain and the requirements for the internal processing and manufacturing of cellular therapy products. The David and Etta Jonas Center for Cellular Therapy, Advanced Cellular Therapeutics Facility, University of Chicago, is a facility that manufactures cellular therapy products in-house. The context and the scope of the validation is an academic cellular therapy processing and manufacturing facility. The facility serves internal cellular therapy program needs, mostly for cancer patients, and produces approximately 400 cellular therapy products each year, including both standard therapy products and clinical trial products.