The Vaccine and Cell Therapy Laboratory (VCTL) serves an important role in translating promising laboratory results into novel therapies by providing a dedicated and controlled facility for the manufacturing of immunotherapies and testing their effectiveness in vaccinated patients for phase I and II clinical trials in cancer and infectious diseases. This highly specialized facility is an essential component of the Tisch Cancer Institute’s Immunotherapy Program.
The VCTL provides two types of services. First, the VCTL can prepare vaccines and cellular immunotherapies in a dedicated, controlled space in accordance with current Good Manufacturing Practice (cGMP) regulations as required by the US Food and Drug Administration (FDA). This cGMP laboratory occupies over 1200 square feet and features three class 10,000 (ISO 7) and one class 100,000 (ISO 8) cleanrooms with separate non-viral and viral equipment rooms, and has been designed with the flexibility to manufacture virtually any type of therapy that uses manipulated human cells such as dendritic cells, NK cells, T cells and regulatory T cells as well as stem cells. In addition, the VCTL has the capability to prepare viral vectors such as oncolytic vectors for cancer therapy and lentiviral vectors encoding antigens of interest. Second, the VCTL also features a very well equipped QC Laboratory that supports the testing and validation of immune therapies prior to application into clinical trials.