- AGC Biologics, a biopharmaceutical CDMO, has received clearance from the U.S. FDA to begin commercial manufacturing of Orchard Therapeutics’ Lenmeldy at its Milan site.
- Lenmeldy is a gene therapy for the treatment of metachromatic leukodystrophy (MLD) and has recently received approval by the FDA.
- With this clearance, AGC Biologics Milan becomes the only global CDMO site to receive the regulatory agency’s clearance to produce this treatment for patients in the U.S. commercially.
AGC Biologics, a biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Milan site to begin commercial manufacturing of Orchard Therapeutics’ Lenmeldy. Lenmeldy (atidarsagene autotemcel) is 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). The FDA approved Lenmeldy on March 18, 2024.
Patricio Massera, CEO of AGC Biologics, expressed his delight at Orchard Therapeutics reaching this milestone. He said, “This accomplishment is a strong proof point of our commitment at AGC Biologics to collaborating directly with developers to meet rigorous regulatory standards and achieve the best possible results for our partners.”
Lenmeldy is the first therapy to receive U.S. FDA approval for MLD. With this announcement, AGC Biologics Milan becomes the only global CDMO site to receive the regulatory agency’s clearance to produce this treatment for patients in the U.S. commercially.
The FDA approval is the culmination of a partnership that started in 2018 with Orchard Therapeutics, which also includes guiding the product through commercial approval by the European Commission (EC) in 2021. AGC Biologics’ Milan site is uniquely connected to this product’s full lifecycle, as the facility and its scientific teams partnered with each company that owned this treatment’s IP over the last 20 years to help advance it from R&D stages to this DP commercial milestone.
Luca Alberici, General Manager of AGC Biologics Milan, expressed pride in the work of the Milan team. He said, “This demonstrates our unique ability to collaborate on technical processes to deliver groundbreaking treatments to patients worldwide. This approval makes our site one of the rare few in the viral vector and genetically modified cells field that has commercial manufacturing authorization from two of the world’s leading regulatory authorities.”
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