Humacyte’s space includes a dedicated 2,500 sq ft clean facility with entry controls, air filtration and a gowning area, that serves as the suite for GMP production of investigational human acellular vessels for Phase I and II clinical trials. The suite is Class 10,000 with HEPA filtered air inputs and high air turnover rates of 12 times per hour. The manufacturing suite contains Sartorius Biostat medium control tanks, large tissue culture incubators to accommodate vessel growth, 4 biosafety (BLA-2) laminar flow hoods, along with associated supportive equipment including microscopes, balances, freezers, refrigerators, centrifuges, welders, sealers, etc.
Humacyte’s analytical/QC laboratory occupies 1000 sq. ft. is also fully equipped for assays such as ELISAs, immunochemical and histochemical detection techniques, electrophoresis, as well as fluorescence microscopy and photomicroscopy. Equipment in the analytical lab includes histology equipment, thermocyclers, gel electrophoresis units, centrifuges, analytical balances, PCR equipment, biological safety cabinets, freezers, refrigerators, etc.
Humacyte’s development laboratory occupies an additional 1000 sq. ft. and is equipped for cell expansion scale up and vessel growth. Equipment in the development lab includes 2 laminal flow biosafety cabinets, Sartorius Biostat medium control tanks, large tissue culture incubators to accommodate vessel growth, spinner flasks, gas analyzers, along with supportive equipment such as microscopes, analytical balances, freezers, refrigerators, centrifuges, welders, sealers, and qRT-PCR equipment. A dedicated, at 200 sq.ft., sub-laboratory adjacent to the development lab processes only human tissue following HCTP guidelines (Reg 1271). The lab contains two laminar flow hoods and 6 tissue culture incubators.
A core prep area is available for sterile staging of all lab and manufacturing materials, and includes a manufacturing scale autoclave available for sterilization needs.