The SKCCC Cell Processing and Gene Therapy (CPGT) Core manufactures clinical grade biotherapeutic material for Phase I/II clinical cell and gene therapy trials. The CPGT Core is comprised of three components: a 400 square foot Process Optimization Lab, a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility that includes 4 manufacturing suites, a general processing area, storage, gown in and gown out areas. The Process Optimization Laboratory is shared by the Cellular Therapy Core (CTC); all labs operate under shared management and oversight. This facility supports the entire Johns Hopkins community in the translation of research concepts into human somatic cell and gene therapy clinical trials.
The services the CPGT Core provides include:
- Manufacture of cell-therapy and gene-therapy based products in an industry-standard clean room environment under current Good Manufacturing Practices (cGMP).
- Prior to production: Optimize and scale-up processes and procedures
- Serve as a regulatory resource to the JHU-SOM in the assistance and/or preparation of cell and gene-therapy based INDs for investigators clinical trials.
- Preparation of Chemistry, Manufacturing and Controls (CMC) sections of investigator-sponsored INDs for Phase I and II clinical trials for products manufactured in the CPGT.
- Perform Stability Testing as required by the FDA for clinical products manufactured in the CPGT.
Facility - Cancer Research Building I 2nd Floor
Offices – Cancer research Building I Suite 1M86
- Ivan Borrello M.D., Resource Medical Director
- M. Victor Lemas, Ph.D., Resource Director
- Janice Davis-Sproul, MAS, MT(ASCP)SBB, Resource Technical Director
- Kalyani Tammareddy, M.Sc., Resource Quality Systems Manager