The mission of the Therapeutic Cell Production Shared Resource (TCP) is to provide Roswell Park Comprehensive Cancer Center CCSG members access to state-of-the-art cell production facility, equipment and regulatory knowledge to facilitate the development, and execution of Phase I and II clinical cell therapy trials. The TCP has the requisite scientific, technical and regulatory expertise and operational efficiencies in cell-based immunotherapies, to implement Phase I and II clinical trials. In 2010, Roswell Park invested significant resources to create our first 600 sq. ft. cGMP facility. With increasing demand, a significant institutional investment was made to expand this footprint to meet expected clinical trials needs of CCSG members. In addition, in 2014, the TCP received CCSG Developmental Funds to support member's use of the facility and services. The TCP is currently a 2,552 sq. ft. FDA compliant cGMP facility with four class 10,000 (ISO7) clean rooms, capable of both simultaneous multi-product and multi-process manufacturing. We provide process development, regulatory support, and cGMP-compliant clinical-grade production of virtually any type 351 biologic, such as dendritic cells and engineered T cell products. The TCP has developed an organized, Standard Operating Procedures (SOP) - driven approach to management of projects, that includes new project feasibility evaluation, project initiation, in-process assessment, completed project assessment, project business close-out and client feedback assessment. During the past five (5) years, the TCP has served 6 Roswell users, all of whom were CCSG members. As the only ISO9001 certified cell therapy manufacturing cleanroom facility in the Western New York region, the TCP is critical to bringing innovative cellular immunotherapies to patients in our catchment area faster.
The Specific Aims of the TCP are: 1) To manufacture type 351 cellular therapy products for clinical trials in support of Phase I and II INDs. The TCP manufactures cGMP compliant cellular therapy products, eg. dendritic cells and engineered T cells for clinical trials to support Phase I and II INDs. Lentivirus or retrovirus vectors that have been produced at the institutional cGMP viral vector and development facility are used to transduce patient's T cells. The products are infused fresh or cryopreserved using GMP- compliant processes and procedures. 2) To provide consultation services for scaling up or out cellular therapy products, and regulatory expertise in compliance with FDA regulations. The TCP assists investigators during protocol development, including identification of sources for clinical-grade materials for translating laboratory findings into clinical trials, and maintains a rigorous Quality program. TCP is responsible for the creation, maintenance, and implementation of a Quality Management System (QMS) for facility operations. Our future plan is to increase the number of CCSG members utilizing the TCP even further by optimizing several new processes and procedures and ultimately reducing cost.
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