The Cellular Therapy Core (CTC) consists of the clinical Cell Therapy Laboratory (CTL) in the Weinberg Building and the Process Optimization Laboratory (POL), a designated lab space in the Bunting-Blaustein Cancer Research Building for translational scale-up studies. This Core supports investigator sponsored clinical trials. These include technology transfer from the research laboratory to the clinical setting, scale up and validation studies. The staff within this laboratory have extensive experience in all aspects of cellular therapy including cGMP Phase I/II manufacturing for autologous products, cGTP manufacturing of blood and bone marrow for transplantation, stem cell biology expertise, immunotherapy expertise and clinical experience in transplantation and cellular therapies. There is extensive QA/QC and regulatory experience for the development of products and compliance with FDA regulations. Staff in this core also provide assistance in the preparation of regulatory documents including IND applications.
Victor Lemas, Ph.D., Resource Laboratory Director
Ivan Borrello M.D., Resource Medical Director
Janice Davis-Sproul, Resource Manager