GMP MANUFACTURING
MolMed S.p.A. is able to satisfy the needs in cell and gene therapies of both academia and the biopharmaceutical industry. Our commitment is to meet your needs in terms of production of viral vectors, genetically modified cells and other cellular therapeutics.
Our 1,400 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.
• Isolation, maintenance in culture and cryopreservation of dendritic cells generated ex vivo.
• Isolation of stem cells with different separation systems.
• Large scale production of human stem cells and cells of different origin.
• Production and expansion of genetically modified human cells.
• Production of genetically modified cells in a closed system.
• Master Cell Banks (MCB) and Working Cell Banks (WCB) are manufactured in compliance with GMP regulations.
• MCB and WCB are tested and characterized in accordance with European and FDA regulatory agency requirements. The test panel includes microbial contamination, cell line identity and in vitro adventitious and endogenous viral test.
• To better conserve the cell banks, we offer long-term storage at our facility in a validated nitrogen liquid tank monitored by a validate monitoring system.
• Retro viral vectors production by roller bottle, cell factory and bioreactor.
• Lentiviral vector production and purification.
FILLING AND STORAGE OF FINAL PRODUCT
