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 EMEA and FDA requirements for the production of clinical-grade bulk drug substances.
Currently, MolMed’s GMP activities include: • production of own cell-based therapeutics • clinical-grade cell manipulation services • development & manufacturing services for investigational gene therapies for rare diseases
MolMed’s acknowledged international reputation in GMP activities for cell and gene therapy makes it an ideal partner for your cell or gene therapy 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 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)
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