CellTrans Inc. has access to a state-of-the-art cGMP facility to manufacture high-quality pancreatic islets. The dedicated clean room complex is located in the lower level of the University Hospital where over 600 islet cell isolation procedures have been performed to date. This facility is intended for the manufacture of isolated pancreatic islets for clinical use and has been used for the manufacture of all lots of isolated pancreatic islets transplanted under IND. The facility includes three rooms of ISO 14644 classified space covering 800 sq. ft. and approx. 1,050 sq. ft. of support space. The support space includes office space for staff, the QC laboratory, receiving area, storage room, observation room, and a room housing the Bac-T/ALERT 3D microbial detection system. Manufacturing and support operations consist of Controlled Not Classified (CNC), ISO 8, and ISO 7 areas. The rooms maintained as CNC space include the QC laboratory 1, Observation room, Raw material storage, and QC Laboratory 2.
The complex islet isolation manufacturing procedure involves the perfusion of the pancreas with a collagenase enzyme, digestion of the pancreas, purification of the islet cells, and culture and quality control testing prior to islet product release.