The Cellular Therapy Core (CTC) enables the translation, scale-up, and validation of promising new therapeutic technologies developed by scientists and/or physicians at a preclinical level, into clinical-grade processes that can be used to manufacture cell-based and/or tissue engineered and/or combination products for clinical applications. It consists of The Judith R. Hoffberger Cellular Therapeutics Laboratory and The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, two state-of-the-art FDA-registered facilities designed and engineered to comply with current Good Manufacturing Practice (cGMP) and Good Tissue Practice (cGTP) of the FDA.
In January 2016, the Griffin facility, located on the 6th floor of the Behavioral and Biomedical Sciences Building (BBSB), was granted accreditation by the Foundation for Accreditation of Cellular Therapy (FACT) for cellular therapy product processing with more than minimal manipulation (see accreditation certificate), becoming one of only three laboratories in Texas with such accreditation and the first in the nation to be accredited under the new Common Standards for Cellular Therapy. The Hoffberger laboratory, located on the 6th floor of the Medical School Building (MSB), was fully validated in early 2017 and applications for FACT, CAP and CLIA inspections have been submitted. In it, we have recently manufactured the first and only clinical-grade tissue engineered esophagus ever implanted in man to date. In Q3 2017, both facilities successfully passed their initial FDA inspection. In both cases, no conditions were found by the FDA to be out of compliance with federal regulations.
The CTC’s mission is to provide innovative clinical-grade cell-based and/or tissue engineered and/or combination products and advanced therapies with quality suitable for intended use in humans; it currently supports multiple clinical trials funded by NIH, DOD, CPRIT, disease-focused nonprofit organizations and industry.
The CTC provides services to in-house investigators, as well as external organizations. We can provide expertise 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 (Pharmaceutical Quality/CMC section)
- FDA-compliant manufacturing of clinical-grade cell-based and/or tissue engineered and/or combination products
Please contact us to discuss your specific needs.