Contacts

GMP Manufacturing

MolMed’s service area GMP Solutions provides tailor-made services for your cell and gene therapy projects; it offers top-level expertise to develop, conduct and validate custom studies, devising innovative testing procedures and addressing the unique test specifications required for novel cell-based therapies.

For MolMed, customer satisfaction is of utmost importance and is guaranteed by strict compliance with the current guidelines issued by all relevant international Regulatory Authorities.
GMP Solutions is a reliable partner for both academic and industry sectors wishing to take a project from its initial stage to final clinical development.
Our commitment is to meet the customer’s needs in terms of production of viral vectors, genetically modified cells and other cellular therapies.

Molmed's 1,500 m2 GMP facility consists of several clean rooms for sterile production. Within this multi-purpose production facility, we can conduct a variety of projects in parallel depending on the needs of our customers, while ensuring the highest standards of quality according to GMP.
Molmed's GMP production capacity for cell and gene therapy includes mass production of stem cells and cells of different origin,  isolation and maintenance in culture of stem cells and the production, expansion and cryopreservation of genetically modified human cells.

These activities are completed by Master Cell Bank (MCB) and Working Cell Bank (WCB) creation in compliance with GMP regulations, GMP production of retroviral and lentiviral vectors, and the purification, filling and storage of final products. MCB and WCB are tested and characterised in accordance with European and FDA Regulatory Agency requirements.
The test panel for their characterisation includes microbial contamination, cell line identity and in vitro adventitious and endogenous virus tests. Moreover we offer long-term MCB and WCB storage at our facility in validated and monitored liquid nitrogen tanks.

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