Seminal gene-modified tumor cell-based clinical trials were initiated and have continued for nearly fifteen years at Johns Hopkins University (JHU). The Cell Processing and Gene Therapy Core (CPGT) was established in 2000 to manufacture clinical grade biotherapeutic material for Phase I/II clinical gene therapy trials at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins. Oversight and resource utilization of the CPGT occurs under the direction of a dedicated committee. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of 4 manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC); all labs operate under shared management and oversight.
This Core has been utilized by 17 faculty members who represent 11 programs within the SKCCC. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials. The mission of the Core is to:
- produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations,
- manufacture novel biological oncolytic agents and clinical grade biotherapeutic reagents that require cGMP, as mandated by the FDA,
- serve as a regulatory resource to the JHUSOM in the preparation of cell and gene-therapy based INDs, and
- provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC cores and laboratories.
To date the CPGT Core has manufactured 15 different types of products. This Core has been responsible for nine SKCCC principal investigator sponsored Phase I/II INDs supporting 17 clinical protocols with over 250 patients treated. This Core continues to facilitate clinical development of novel cancer therapies.
- Elizabeth Jaffee M.D., Medical Director
- Carol Kobrin, Ph.D., Resource Director
- M. Patricia Harris, M.Sc., Quality Systems Manager
- Karie Bennett, M.S., Manufacturing Manager