Provide patients suffering from
severe or rare, untreatable diseases
with stem cell-based advanced therapies
through ethical and scientific excellence
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.
The centre for Regenerative Medicine "Stefano Ferrari" (CMR)
is a 4-floor building of 4.000 sq meters. CMR fulfills international GMP requirements for cell-based advanced therapies.
© 2017 Holostem Terapie Avanzate S.r.l.
VAT: 03213240363 -
Payed Up Capital: Euro 700.000,00
Companies Register Office - Modena: 03213240363
Registered with the Administrative Economic Register: MO-368370
Company subject to the management and coordination of Valline s.r.l.
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Holostem Terapie Avanzate's pipeline includes Advanced Therapy Medicinal Products at different stage of development. Our research activity is aimed to develop new protocols for cell and gene therapy based on different types of epithelial stem cells.