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AGC’s Milan site now has clearances from both U.S. and European regulators to supply the HSC-based gene therapy using approved commercial processes.
March 19, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
AGC Biologics, a global biopharmaceutical CDMO, today announced that the U.S. FDA has cleared its Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received ap...
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