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March 2024

AGC Biologics to Manufacture First FDA-Approved Gene Therapy for Early-Onset MLD at OpenZone 


AGC Biologics Milan site within our OpenZone campus now has clearances from both U.S. and European regulators to supply patients with HSC-based gene therapy using approved commercial processes
 
Our Zoner AGC Biologics announced that the U.S. Food and Drug Administration (FDA) has cleared their Milan site located here at OpenZone, 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 approval by the FDA on Monday, March 18.   
 
Patricio Massera
CEO, AGC Biologics

It is wonderful to see Orchard Therapeutics reach this goal. 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 based within OpenZone campus is uniquely connected to this product’s full lifecycle, as the facility and our scientific teams partnered with each company that owned this treatment’s IP over the last 20 years to help advance it from research and development stages to this DP commercial milestone. 
Luca Alberici
General Manager of AGC Biologics Milan

 

We congratulate Orchard for reaching this important stage. Our team has had the privilege of supplying every clinical milestone for Lenmeldy and are glad to see it reach FDA approval. I am proud of the work of the Milan team.  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.

 

The AGC Biologics Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage. The site serves as the AGC Biologics’ Global Cell and Gene Center of Excellence for AGC Biologics. 
The team has a track record for helping developers meet regulatory guidelines and achieve quality performance metrics, and experience with navigating the unique complexities of technology transfers and scaling up and scaling out manufacturing within the cell and gene space.  
AGC Biologics Milan headquarters inside the OpenZone campus.
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