University of Pennsylvania CGMP Cleanroom+Research Lab

  • Pancreatic Islet Transplantation 
    The success of the HPAP (human pancreas analysis program) in the treatment of Type 1 Diabetes has led the research group to pursue a BLA for an FDA approved aseptic processing facility where pancreatic islet cells can be harvested for the benefit of a new host. 

    Cleanroom Environment
    The facility will support a new ISO-7 cleanroom and associated support facilities in compliance with cGMP (Current Good Manufacturing Practices) standards. The cleanroom suite of 2,136 SF will include cold and clean storage, gowning in and out, and maintenance support facilities. Separated from the cleanroom functions, but associated with the islet cell processes will be a QC Lab and Research Lab.