Since July 2003, MolMed is formally authorised for the production and release of medicinal products for human use. We run a in-house GMP facility that meets both EMA and FDA requirements for the production of clinical-grade bulk drug substances. 

MolMed’s GMP activities include:

• production of own investigational cell-based therapeutic product TK

• the area "GMP Solutions", offering tailored services to third parties for development & manufacturing of clinical-grade cell and gene therapies

MolMed’s acknowledged international reputation in cell and gene therapy makes it an ideal partner for your projects. We can provide you with an integrated platform, including:
• customised project design, from preclinical to Phase III trials
• release of clinical-grade lots by MolMed’s Qualified Person
• regulatory support
 
MolMed’s remarkable track record in GMP manufacturing of investigational gene therapies includes:
• ADA-SCID, for the San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET)
• Metachromatic Leukodystrophy (MLD), for the Telethon Foundation
• Wiskott-Aldrich syndrome (WAS), for the Telethon Foundation

MolMed is partner in the following EU-funded R&D projects focused on cell or gene therapy:
• cell therapy for Duchenne muscular dystrophy (OPTISTEM)
• lentiviral vectors for gene therapy applications (PERSIST)
• advanced cell-based therapies for the treatment of primary immunodeficiency (CELL-PID)  

 
For more information, please visit the MolMed GMP Solutions website