AGC Biologics becomes first manufacturer of newly approved Libmeldy

AGC Biologic's Milan facility

The CDMO will use its gene and cell therapy commercial expertise to bring "remarkable innovation" to young eligible patients

The drug, which was recently approved by the European Commission as a one-time therapy for eligible patients with early-onset Metachromatic Leukodystrophy (MLD), will be manufactured at the CDMO's Milan facility.

Orchard Therapeutics is already underway with EU launch preparations to support commercial-scale drug manufacturing at the AGC Biologics Milan facility.

AGC Biologics Chief Business Officer, Mark Womack, said: “We’re very proud to be one of few cell and gene therapy CDMOs with commercial experience – Libmeldy being the third commercial product we’ve manufactured – and we look forward to continuing our partnership with Orchard to provide this life-changing therapy to those affected by MLD.”

The CDMO has been part of the entire clinical journey of Libmeldy (also known as OTL-200), from the first treated patient all the way to market approval. The company will continue its partnership with Orchard Therapeutics by manufacturing both lentiviral vector and drug product.