Holostem Terapie Avanzate manages a GMP facility authorized (AIFA decree n. aM – 169/2014) to manufacture Advanced Therapy Medicinal Products for commercial use and for clinical trials.
The GMP facility, located into the Centre for Regenerative Medicine “Stefano Ferrari” of the University of Modena and Reggio Emilia, has 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.