The first Gene Therapy clinical trials begin at the Johns Hopkins University in 1992. Material for these studies was generated in part by a small Good Laboratory Practice (GLP) facility on the third floor of the Ross Building and in part by an outside GMP facility. The small GLP facility has since been replaced by The Johns Hopkins University Cell Processing and Gene Therapy Laboratories. These laboratories are composed of two administratively linked laboratories: a 400 square foot GLP room (the Developmental Immunology Laboratory) for pre-scale up development and for scale-up of therapies that can be performed with minimal manipulation and/or in a closed system; and an 1800 square foot fully cGMP facility for the manufacture of clinical grade, bio-therapeutic material for gene therapy phase I and II clinical studies. Five to seven individuals with training in cGMP, cellular and viral manipulations, as well as process development staff the Core facility. The configuration of the Cell Processing and Gene Therapy Facilities allows the simultaneous processing of four clinical products, with development of two to three pre-clinical scale-up projects within the Development Laboratory. This Core is currently utilized by more than ten faculty members who represent five programs within the Oncology department, and faculty members from at least two other departments in the School of Medicine. The mission of the Cell Processing and Gene Therapy Facility at Johns Hopkins University is to act as a resource within the Johns Hopkins Community, providing expertise for the advancement of basic research on human somatic cell and gene therapy. Specifically, this facility supports translational research with: 1) in-house cell expansion and cell separation expertise for phase I and II clinical trials; 2) in-house manufacturing of clinical grade, bio-therapeutics for phase I and II clinical trials; and 3) production of biologic agents under current Good Manufacturing Practices (cGMP) as advised by the United States Food and Drug Administration to ensure the safest possible products for our patients. This CORE facility has already accelerated the initial clinical testing of several vaccines that were developed in laboratories at the Johns Hopkins University. Because the translational activity in somatic cell and gene therapy within the Cancer Center is quite substantial, we expect this CORE to continue to facilitate the clinical development of new therapies for most types of cancer.
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