GMP Grade Cell Processing
Good Manufacturing Practices (GMP) are necessary for preparing cells and viral reagents for clinical trials. The Cell Preparation and Analysis Core will synergize with the existing Yale Laboratory for Advanced Cell Therapy, a GMP laboratory run by Dr. Diane Krause, to help YCCEH members with GMP-grade cell preparation. Dr. Krause will provide free consultation and advice on this service. Charges will be based on cost-recovery.
The newly designed Yale Laboratory for Advanced Cell Therapy was completed in 2014, with 2 separate ISO 7 rooms, each fed by a class 10,000 shared equipment corridor. The laboratory can serve the cell therapy clinical trials at Yale University and other institutions. The laboratory staff has expertise in performing clinical-scale preclinical trials for FDA applications. To date, the laboratory has processed cells for seven investigator-initiated clinical trials at Yale as well as nine company-sponsored clinical cell therapy trials. As part of the U54 NIDDK CCEH consortium, this laboratory could be available to all of the institutions in the consortium, based on availability.