The Midwest Stem Cell Therapy Center (MSCTC) is a state-of-the-art GMP facility located within The University of Kansas Medical Center. Launched in 2013, MSCTC is a qualified facility for the development and processing of clinical grade stem cells from adult tissues, cord blood and related materials for clinical trials and for scale up processing of some of these cellular products for potential therapeutic use.
The facility houses two fully equipped modular clean room suites specifically designed for cell therapy applications including autologous stem cell processing and cell culture research that provides development, processing and packaging capacity for the cellular products intended for early research, clinical trials and eventual therapeutic use. The operation of the clean room suites is classified and maintained under ISO designation 7/ Class 10,000 classification and is in accordance with the CFR Title 21, Parts 210 and 211, 21 CFR 1271 and applicable provisions from 21 CFR 820 and other supporting FDA guidelines. The validation of the Clean room facility was completed based upon the guideline of the FDA for GMP operations with special emphasis on processing of cellular products.
This enables MSCTC to use the Clean Room Facility to develop, manufacture and package pharmaceutical products under a GMP format to ensure safe application of any products developed or facilitated from this site. Both clean room suites contain gowning rooms, material pass-throughs and an independent HEPA filtered HVAC unit that supply/return pre-treated air dedicated to the clean room suites and provides room pressurization with pressure differentials minimizing the potential for material and product migration. A critical part of the containment is achieved by using local dust collection system in conjunction with maintaining the processing spaces under a negative pressure cascade. Critical facility parameters, critical controls and laboratory equipments are validated and are continuously monitored via a wireless alarm system, with on and offsite surveillance and data collection.
All areas of the production facility have controlled access and are designed and maintained to a high standard of regulatory compliance and environmental quality. The design ensures orderly flow of raw materials, processes, and personnel. Under the direction of Buddhadeb Dawn, M.D. who serves as the Center director, The Midwest Stem Cell Therapy Center is fully operational and is involved as a research organization for a Phase I/II clinical trial.