The Friendly CDMO Expert’s Milan Cell and Gene Center of Excellence Achieves 10th Major Regulatory Product Approval

Following news on July 21 that the European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel – obe-cel), AGC Biologics’ Milan site achieved its 10th product approval from the European Medicines Agency or the U.S. Food and Drug Administration.

Developed by Autolus Therapeutics, AUCATZYL® is now approved to treat adult patients (age 26 and older) in 27 European Union member states with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows the therapy’s prior authorizations from the FDA in November 2024 and the U.K. Medicines and Healthcare products Regulatory Agency in April 2025.

This latest step further solidifies AGC Biologics’ Milan Cell and Gene Center of Excellence’s reputation as a global leader in the field, built on a 30-year track record of quality, reliability, and regulatory success.

“This European approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry’s safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization,” said Alberto Santagostino, CEO and President, AGC Biologics. “By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients. Congratulations to the entire Autolus team.”

The partnership between Autolus and AGC Biologics Milan began in 2020, with the CDMO tasked to develop, manufacture, and supply the viral vectors for Autolus’ obe-cel CAR-T product candidate.

“From the start of our partnership in 2020, through the FDA approval and now this European authorization, our collaboration with Autolus has been a model of true partnership,” said Luca Alberici, General Manager, AGC Biologics Milan. “The team’s sustained dedication and technical excellence is a direct result of our ability to work seamlessly with the Autolus team to meet the demands of commercial-scale manufacturing for a global market.”

With its 30-year track record and 10 product approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects. The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up.

To learn more about AGC Biologics’ global cell therapy services, visit www.agcbio.com/capabilities/cell-therapy, and for more on the CDMO’s viral vector offerings, visit www.agcbio.com/capabilities/viral-vector.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

AUCATZYL® (obecabtagene autoleucel – obe-cel) is a registered trademark of Autolus Therapeutics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250731953715/en/