EMA Approves CAR-T Therapy Manufactured by AGC Biologics

The European Commission recently approved AUCATZYL (obecabtagene autoleucel – obe-cel), marking the 10th product approval for AGC Biologics’ Milan site from the EMA or the U.S. FDA.

Developed by Autolus Therapeutics, AUCATZYL is approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows prior authorizations from the FDA in November 2024 and the U.K. MHRA in April 2025.

“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 AGC 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.”