GMP Biologics Core
Seminal gene-modified tumor cell-based clinical trials have been ongoing at Johns Hopkins for more than two decades. The GMP Biologics Core was established in 2000 to manufacture clinical grade biotherapeutic material for Phase I/II clinical gene therapy trials at the Kimmel Cancer Center. This Core is composed of:
- a Process Optimization laboratory
- Materials Management/Quality Control laboratory
- a cGMP Classified-Clean Room facility with four manufacturing suites
- a general processing area, product storage, and gown-in and gown-out areas
The Process Optimization Laboratory is shared by the Cellular Therapy Core.
The GMP Biologics Core supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials. Its mission 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 the FDA.
- 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 School of Medicine in the preparation of cell and gene-therapy based (new drug) INDs.
- support technology transfer from the GMP-BC to contract manufacturers as clinical trials progress to Phase III status.
To date, the Core has manufactured 32 different types of products, including master cell banks, working cell banks, and clinical lots. It has been responsible for 14 principal investigator-sponsored Phase I/II INDs, supporting 31 clinical protocols with over 900 patients treated. This Core continues to facilitate clinical development of novel cancer therapies.
Ivan Borrello, M.D.
Resource Medical Director
M. Victor Lemas, Ph.D.
Resource Laboratory Director