Roswell Park Cancer Institute
Elm & Carlton Streets
Buffalo, NY 14263United Stateshttps://www.roswellpark.edu/shared-resources/cgmp-facility
Last Updated: 11/05/2014
The Center for Immunotherapy, ISO9001:2008 registered Therapeutic Cell Production Facility (TCPF) at the Roswell Park Cancer Institute was designed to fulfill US FDA cGMP requirements in support of 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.
GMP and Research Hypoxia Chamber
Services are offerred outside of Roswell Park Cancer Institute
Consulting is offerred outside of Roswell Park Cancer Institute