Holostem runs a 2.000 sq meters GMP facility located into the Centre for Regenerative Medicine “Stefano Ferrari” of Modena, one of the biggest research centers in the world entirely dedicated to epithelial stem cells cultures.
The Centre for Regenerative Medicine “Stefano Ferrari” (CMR) of the University of Modena and Reggio Emilia is a 4-floor building of 4.000 sq meters, opened on October 2008.
CMR fulfills international GMP requirements for cell-based advanced therapies .
The ground floor contains: reception, administration, offices, meeting and storage rooms; external to the building there a plant room containing a 5.500-litres tank for liquid nitrogen and a dual ramp exchange control unit for carbon dioxide (a third ramp is available in case of emergency), both with automated computerized distribution lines.
The first floor is dedicated to basic research and consists of 5 fully equipped BL2 cell culture rooms and laboratories fully equipped for biochemistry, molecular biology, confocal microscopy, immunofluorescence, laser microdissection, time-laps microscopy, X-ray cell irradiation, cytofluorimetry, histology, cytology, real-time PCR.
The second floor contains the GMP facility run by Holostem with 17 independent BL2 rooms fully equipped for cell culture, quality controls and common culture media and reagent preparation. The GMP facility contains also a machinery for automated quantitative immunohistochemistry and in situ hybridization, terminals for control and monitoring system and is equipped for histology, immunofluorescence and X-ray cell irradiation.
The top floor (plant room) has, beyond other equipments, 15 HVAC (High Volume Air Conditioner) to feed sterile air to cell culture rooms, vacuum generation and
distribution line, a central unit for production and distribution of purified water (according to EU Pharmacopoeia), an UPS (Uninterruptible Power Supply).
Planned maintenance and calibration are regularly applied to every equipment and process.
