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The Cellular Therapy Core consists of the clinical Cell Therapy Laboratory and the Process Optimization Laboratory, a designated facility for translational scale-up studies. This Core supports investigator-sponsored clinical trials, including technology transfer from the research laboratory to the clinical setting, scale-up and validation studies. Laboratory staff have extensive expertise in all aspects of cellular therapy, including:
- cGMP Phase I/II manufacturing for production of autologous/allogeneic products
- cGTP manufacturing of blood and bone marrow for transplantation
- stem cell biology
- transplantation and cellular therapies.
Core staff also have Quality Assurance (QA)/Quality Control (QC) and regulatory experience for the development of products and compliance with U.S. Food and Drug Administration (FDA) regulations. They assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications.
Victor Lemas, Ph.D., Resource Laboratory Director
Ivan Borrello M.D., Resource Medical Director
Janice Davis-Sproul, Resource Manager