The ISO9001:2008 registered Therapeutic Cell Production Facility (TCPF) at Roswell Park Comprehensive Cancer Center was designed to fulfill U.S. Food and Drug Administration (FDA) cGMP requirements. The TCPF manufactures therapeutic cell products in support of Phase I and II clinical cell therapy trials for Roswell Park and regional investigators, as well as biotech collaborators.
Services
The Therapeutic Cell Production Facility is available to assist investigators in the manufacture of clinical products for clinical cell therapy trials, from drafting trial-specific Standard Operating Procedures (SOPs), IND CMC preparation, QC testing and validation services to the manufacture of clinical therapeutic products.