AGC Biologics’ Milan facility has achieved a significant regulatory milestone, securing its tenth product approval from either the EMA or FDA, with the latest being the European Commission’s authorization of AUCATZYL® (obecabtagene autoleucel – obe-cel), a revolutionary CAR-T therapy. This pivotal development underscores the company’s critical role in advancing next-generation cell and gene therapies for global patients.
The newly approved AUCATZYL®, developed by Autolus Therapeutics, is now sanctioned for use across all 27 European Union member states. This therapy is specifically designed to treat adults aged 26 and over suffering from relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL), offering a vital new treatment avenue for patients with limited options.
This substantial European regulatory milestone for AUCATZYL® follows earlier clearances in key international markets, including successful regulatory approvals in the United States in November 2024 and the United Kingdom in April 2025. Such multi-region endorsements highlight the therapy’s efficacy and the robust regulatory processes it has undergone.
Central to the success of AUCATZYL® is AGC Biologics’ Milan facility, a distinguished Contract Development and Manufacturing Organization (CDMO) with an impressive 30-year operational history. Since establishing a strategic partnership with Autolus in 2020, the Milan site has been the exclusive supplier of the critical lentiviral vector, an essential component for this advanced CAR-T therapy.
Alberto Santagostino, CEO and President of AGC Biologics, expressed profound satisfaction with this achievement, stating, “This European approval for Autolus is a milestone we are thrilled to be part of.” He emphasized the company’s commitment to ensuring a reliable supply of vital lentiviral vectors, thereby empowering partners like Autolus to maintain their focus squarely on patient needs and outcomes.
The Milan site has cultivated a reputation as a cornerstone for clinical and commercial-scale contract manufacturing, particularly excelling in the complex production of cell and gene therapies. Its extensive experience and adherence to stringent global regulatory standards have positioned it as a leader in supporting innovative biopharmaceutical developments.
Luca Alberici, General Manager of the Milan facility, highlighted the profound nature of their collaboration with Autolus, describing it as “a model of true partnership.” This synergistic relationship is instrumental in meeting the demanding requirements of global pharmaceutical manufacturing, ensuring that crucial biologics approvals translate into widespread patient access.
The dedicated team at AGC Biologics Milan has a proven track record of supporting numerous products from their initial clinical development stages through to market authorization. This includes manufacturing hundreds of clinical batches while meticulously adhering to diverse global regulatory standards and technical transfer requirements, solidifying their expertise in pharmaceutical CDMO operations.
The successful authorization of AUCATZYL® serves as a testament to the power of collaborative innovation within the biopharmaceutical industry, demonstrating how specialized CDMOs are pivotal in transforming groundbreaking research into life-changing medical treatments and accelerating the availability of advanced CAR-T therapy and cell gene therapy solutions worldwide.
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