The Diabetes Research Institute provides access to cGMP/GTP (current Good Manufacturing Practices/Good Tissue Practices) cell production for clinical trials.
The cGMP/GTP Cell Processing Facility is located on the 4th floor of the DRI building. Scientific and technical leadership of the facility provides complementary expertise in the clinical and translational sciences and cell processing. The cGMP/GTP compliant laboratories operate under strict, approved standard operating procedures.
Pancreatic islets, vertebral body and iliac crest bone marrow, cord blood and mobilized peripheral blood have been processed for transplant for over a decade. Over the past 3 years, 2 different lung cancer vaccines, mesenchymal stem cells for multiple clinical trials, cultured bone marrow cells, and T-regulatory and NK cell selection have been added to the repertoire of services and capabilities rendered.
The facility offers expertise in such areas as:
- cryopreservation and thawing of various cell types; and
- development of technical, analytical methods and quality systems SOPs
The facility also offers specific expertise in the regulatory processes pertaining to the development of various biologics, based on the detailed understanding of a unique biochemical nature of each product.
Regulatory capabilities include:
- know-how in product manufacturing, process control and testing
- inspections and audits
- practical knowledge of various FDA regulatory documents that provide the necessary framework for product development
- IND development, review and submission
The facility is registered with the FDA and accredited by FACT (Foundation for Accreditation of Cellular Therapies) and AABB (American Association for Blood Banks).