AGC Biologics, a biopharmaceutical Contract Development and Manufacturing Organization (CDMO), is the first manufacturer of Orchard Therapeutics‘ Libmeldy, which was recently approved by the European Commission as a one-time therapy for early-onset Metachromatic Leukodystrophy (MLD), a rare neurodegenerative disorder caused by mutations in the ARSA gene.
 
Libmeldy (autologous CD34+ cells encoding the ARSA gene), is a lentiviral vector-based gene therapy manufactured at AGC Biologics’ Milan facility. Orchard Therapeutics’ EU launch preparations are underway to support commercial-scale drug manufacturing at AGC Biologics’ Milan facility.
 
“We are very honored to have been a part of the entire clinical journey of this product, from the very first treated patient, all the way to market approval. As manufacturer of both lentiviral vector and drug product, we are proud to support Orchard in treating this devastating disease,” said AGC Biologics General Manager of Milan, Luca Alberici.
 
“The EC approval of Libmeldy opens up tremendous possibilities for eligible MLD children faced with this devastating disease,” said Bobby Gaspar, M.D., Ph.D., Chief Executive Officer of Orchard. “We are humbled by the opportunity to bring this remarkable innovation to young eligible patients in the EU, and confident in the capabilities of our partners at AGC Biologics to help us achieve this goal.”