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, located on the 6th floor of the Medical School Building (MSB), and The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, located on the 6th floor of the Behavioral and Biomedical Sciences Building (BBSB), two state-of-the-art CLIA- and FDA-registered facilities designed and engineered to comply with current Good Manufacturing Practice (cGMP) and Good Tissue Practice (cGTP) of the FDA.
Both facilities successfully passed FDA inspection with all conditions found to be in compliance with federal regulations, and are accredited by the College of American Pathologists (CAP) and the Foundation for Accreditation of Cellular Therapy (FACT) for cellular therapy product processing with more than minimal manipulation (see accreditation certificate), two of only four laboratories in Texas with such accreditation and the first in the nation to be accredited under the new Common Standards for Cellular Therapy.
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 cGMP-compliant documents, such as Standard Operating Procedures (SOPs), Production Batch Records, Validation Plans, etc.
- 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
- Clinical Flow-cytometry services
- FDA-compliant Quality Control Testing
Please contact us to discuss your specific needs.
Contact for further information:
Fabio Triolo, Ph.D., Director
phone: (713) 500-7309 HIPAA secure fax: (713) 383-3704