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AGC Biologics Manufactures Orchard Therapeutics’ Libmeldy

European Commission approves one-time therapy for early-onset Metachromatic Leukodystrophy, manufactured at AGC's Milan facility.

By: Contract Pharma

Contract Pharma Staff

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&#82...

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