Contacts

Facilities

MolMed's facility for GMP production is located at the company headquarters in via Olgettina 58 Milan, in the DIBIT (Department of Biotechnology of the San Raffaele) building while a new larger facility is in the final phase of construction at the site "Open Zone" in Bresso (MI).
The currently operating facility was formally authorised in 2003 by the Italian Medicines Agency (AIFA) for the production and release of medicinal products, and complies with the requirements of current legislation and best practice guidelines for the manufacturing of patient-specific or genetically modified cells and active pharmaceutical ingredients for clinical use.

Molmed's laboratory equipment including centrifuges, incubators, analytical instruments and cold storage. Moreover adequate resources were dedicated to cell and viral supernatant production which also using bioreactors and retroviral and lentiviral vector purification systems such as Akta Pilot and Akta purifier.

All instrumentation is installed and managed by a GMP compliant Validation Master Plan with IQ, OQ and PQ qualification.
Molmed's GMP facility at DIBIT occupies an area of 1,500 m2 (about 15,000 sqft) and includes:

  • 5 cell manipulation rooms (three for gene therapy and two for cell therapy)
  • one room for viral vector production and one for viral vector purification.
  • one clean room for quality control activities

Each room is supported by independent filtering and air extractor systems (HVAC).
The HVAC system is designed to provide grade B, C and D air. For product handling, biocontainment laminar flow hoods are installed. These generate unidirectional air flow complying with class A limits (microbial and particle counts).
According to specific procedures, a regular monitoring programme has been established for the control of air class and environmental conditions.

The new MolMed facility in Bresso "Open Zone" has been designed and built to meet the highest quality and functionality standards in the field of gene and cell therapy and, with over 3,300 m2 (33,000 sqft) will significantly expand the Company's production capacity, both in view of the future commercialization of Zalmoxis® (TK) and to face the increasing number of activities for third parties.

MolMed S.p.A. Via Olgettina, 58 - 20132 Milano, Italy | Phone +39 0221277.1 - Fax +39 02 21277.325 | info@molmed.com - www.molmed.com
Share capital € 20,949,084.36 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159