The Cell Therapy and Cell Engineering Facility develops, validates, and implements procedures critical to gene transfer-related clinical research at Memorial Sloan Kettering. The quality assurance and quality control unit (QA/QC) is essential for providing a laboratory environment compliant with NIH and FDA guidelines.
The role of the facility is to support preclinical and clinical research in the following functions:
- Genetic engineering and ex vivo transduction of patient cells (hematopoietic stem cells, dendritic cells, and lymphocytes).
- Vector production (clinical-grade plasmid DNA and retroviral vectors).
- Research and development work relating to vector production and transduction of patient cells.
- Molecular analysis of gene transfer efficiency and transgene expression in patient cells and tissues (FACS analysis, real-time PCR, immunostaining, etc.).
- Quality control and biosafety testing of clinical reagents and patient cells.
Currently, the projects revolve around the development of gene transfer approaches for the treatment of melanoma and various types of lymphoma. These projects involve the production of plasmid DNA vaccines; the generation of genetically modified dendritic cells and genetically targeted T lymphocytes; as well as the engineering of artificial antigen presenting cells.