The Cellular Therapy Core (CTC) consists of the Judith R. Hoffberger Cellular Therapeutics Laboratory and the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory. The Hoffberger laboratory is located on the 6th floor of the UT Medical School Building (MSB) and is focused on translating, scaling-up, validating and supporting IND applications (CMC section) of promising new therapeutic technologies developed by scientists and physicians at a pre-clinical level into clinical-grade processes that can be used to manufacture cell-based and/or tissue engineered products for clinical applications. The Griffin Laboratory is located on the 6th floor of the Behavioral and Biomedical Sciences Building (BBSB) and is an FDA-registered facility accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for Cellular Therapy Product Processing with more than minimal manipulation (see accreditation certificate). In the Griffin lab, tissues and organs are processed to produce cells for clinical applications in compliance with current Good Manufacturing Practice (cGMP).
Services provided by the Cellular Therapy Core include:
- Early involvement of experts in regulatory issues and process development
- Development and/or translation, optimization, scale-up and validation of manufacturing processes
- Development and writing of Standard Operating Procedures (SOPs)
- Development and validation of protocol-specific quality control (QC) assays
- Support of IND applications (CMC section)
- cGMP-compliant manufacturing of clinical-grade cell and/or tissue engineering products
Please contact us to discuss your specific needs.