Occupying approximately 1200 sq ft., this state-of-the-art lab was designed to facilitate cGMP processing of hematopoietic and somatic progenitor cells, and has been externally audited for compliance. The HSCLab is adequately equipped for cell processing, testing and cryopreservation. Processing equipment includes centrifuges, biosafety cabinets, and dedicated bone and adipose-processing instrumentation. Testing equipment includes two flow cytometers, a hematology analyzer, and a fluorescent microscope. The Liquid Nitrogen Storage Facility includes three controlled rate freezers, seven storage vessels with capacity of 500 cryopreserved components each, and an automatic LN2 filling system with redundant sources, continuous monitoring and autodial alarm system for all LN2 vessels.
The HSCLab is divided into two main work areas. The Testing Lab and Cleanroom are designed for GMP workflow, are interlinked and together occupy 800 square feet. The lab is entered via a “locker room” that provides for a change of shoes and donning a lab coat to wear in the outer laboratory. The outer lab is supplied with HEPA filtered air and positive pressure with respect to the corridor. It has a hard ceiling, a one-piece floor, and stainless steel casework. The outer lab is joined to the inner Cleanroom with an interlocked gowning anteroom (such that the door to the outer lab and the door to the Cleanroom cannot be simultaneously opened). There is also a specimen pass-through from the outer lab to the Cleanroom. The Cleanroom has been designed to exceed class 10,000 (ISO 7) requirements. It has ceiling mounted HEPA filters and is positive pressure with respect to the outer lab. It has a “waste out” room that connects to the corridor with an interlock, such that the door to the cleanroom and the door to the corridor cannot be opened simultaneously.