To act as a shared resource within and outside the Roswell Park community, providing expertise and know-how for the advancement of therapeutic cellular research into the clinical setting.
To facilitate and enable Roswell Park’s successful drive for leadership in the development of cell therapy products and services.
About the Therapeutic Cell Production Facility
The Center for Immunotherapy, ISO9001:2008 registered Therapeutic Cell Production Facility (TCPF) at Roswell Park Cancer Institute was designed to fulfill U.S. Food and Drug Administration (FDA) cGMP requirements to support cell therapy clinical trials.
Occupying 2574 ft2, the TCPF multiuse cleanroom suite is made up of three ISO 7 production rooms and one ISO 7 flex production room. Additionally, an onsite QC laboratory can perform requisite testing for cell therapy investigational products. Suite and production room entry is controlled via an electronic card access security system, with centralized monitoring of air and equipment. The anterooms and production rooms house refrigerators and low-temperature freezers with appropriate data logging capabilities and are connected to a central monitoring system. Dedicated TCPF personnel are responsible for maintaining the cleanroom and equipment as required by the FDA.
The TCPF is fully equipped to provide broad and comprehensive cell processing capabilities. The TCPF has expertise to assist with a variety of cell manufacturing needs.
Roswell Park Cancer Institute
Therapeutic Cell Production Facility
CCC, Room C-404
Elm and Carlton Streets
Buffalo, New York 14263
Monday–Friday, 8 a.m.–5 p.m.