The Midwest Stem Cell Therapy Center (MSCTC) has a state-of-the-art GMP facility (FDA registration number FEI: 3011110834) located in the Lied building within the University of Kansas Medical Center. This 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 cellular products for potential therapeutic use.
The facility includes two fully equipped modular clean room suites specifically designed for cell therapy applications, including processing of autologous stem cells and cell culture that support the generation of cellular products intended for preclinical 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 clean room suites contain gowning rooms, material pass-throughs and an independent HEPA filtered HVAC unit that returns pretreated 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. Various critical facility parameters, critical controls and laboratory equipment are continuously monitored via a wireless alarm system, with both on- and off-site surveillance and data collection.
The validation of the clean room facility is completed regularly in compliance with the guideline of the FDA for GMP operations with special emphasis on processing of cellular products. 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. This enables the development, manufacturing and packaging of adult cell therapy products under a GMP format to ensure safe application of any product developed or processed at this site.
The MSCTC GMP facility is currently operational and involved as a production site for cellular materials for clinical trials.