European Commission Greenlights AUCATZYL®: AGC Biologics Marks 10th Regulatory Approval with Autolus’ CAR-T Therapy
AGC Biologics, a global contract development and manufacturing organization (CDMO) specializing in biologics and advanced therapies, has reached another significant milestone. On July 21, the European Commission (EC) officially granted marketing authorization for AUCATZYL® (obecabtagene autoleucel, or obe-cel), a CAR-T cell therapy developed by Autolus Therapeutics. This decision marks the 10th product approval supported by AGC Biologics’ Milan site—a Cell and Gene Center of Excellence that has now achieved regulatory success with both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
The approval authorizes AUCATZYL® for the treatment of adult patients aged 26 and older diagnosed with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) in all 27 European Union member states. This regulatory greenlight follows closely on the heels of obe-cel’s U.S. FDA approval in November 2024, and a U.K. Medicines and Healthcare products Regulatory Agency (MHRA) authorization in April 2025, signaling expanding global access to this innovative CAR-T cell therapy.
A CDMO Milestone Anchored in Long-Term Collaboration
“This European approval for Autolus is a milestone we are thrilled to be part of,” said Alberto Santagostino, CEO and President of AGC Biologics. “Our goal is to be the industry’s safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization. By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients.”
The collaboration between Autolus and AGC Biologics began in 2020, with AGC’s Milan facility entrusted with the development, manufacturing, and commercial supply of lentiviral vectors, a critical component in the production of Autolus’ obe-cel CAR-T product.
“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,” added Luca Alberici, General Manager of 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.”
The achievement highlights the importance of strong CDMO partnerships in the cell and gene therapy (CGT) space—where production reliability, regulatory experience, and technical expertise can determine whether life-saving therapies reach patients efficiently and at scale.
AUCATZYL® and the Expanding CAR-T Landscape
AUCATZYL® (obe-cel) is an investigational CD19-directed autologous CAR-T cell therapy that incorporates a fast off-rate CD19 binding domain designed to enhance persistence and reduce toxicity. It represents a next-generation approach in CAR-T technology and has been developed with the goal of improving outcomes in a difficult-to-treat population—adults with r/r B-ALL who often have limited therapeutic options and poor prognoses.
The European Commission’s approval is based on robust data from the FELIX Phase 1b/2 trial, which demonstrated compelling efficacy and a favorable safety profile in adult patients. These clinical findings contributed not only to the FDA’s decision in 2024 but also to accelerating the product’s path to market across Europe.
AGC Biologics Milan: A Manufacturing Powerhouse for CGT Innovation
AGC Biologics’ Milan facility has steadily built a reputation as a center of excellence for cell and gene therapy manufacturing, anchored by its 30-year history in biologics production. The site has become a cornerstone for lentiviral vector development and large-scale production—an increasingly critical capability as more CAR-T and gene therapy products transition from clinical development to commercial delivery.
With 10 product approvals—including several from both EMA and FDA—the Milan team has emerged as a trusted manufacturing partner for biopharmaceutical companies worldwide. These successes stem from a strong foundation in complex tech transfers, process optimization, and clinical and commercial-scale GMP manufacturing. The facility has produced hundreds of batches for global clinical trials and commercial supply, consistently achieving the highest standards in quality, compliance, and scalability.
AGC Biologics’ Milan site offers:
- Process development and optimization for lentiviral and retroviral vectors
- Clinical and commercial GMP manufacturing
- Fill and finish capabilities
- Analytical testing and regulatory support
- Scalable infrastructure to accommodate early- to late-stage programs
Building a Trusted Ecosystem for Advanced Therapies
The AUCATZYL® approval also underscores AGC Biologics’ commitment to building a safe, scalable, and globally integrated manufacturing ecosystem for cell and gene therapies. As more CGT products emerge from pipelines worldwide, CDMOs must not only demonstrate scientific and technical excellence but also operate with agility and transparency to support their partners’ success through each stage of development.
“Our focus is always on enabling our partners to bring their therapies to patients efficiently and reliably,” noted Santagostino. “This includes reducing the risks of scale-up, regulatory delays, and supply chain disruptions—all while providing the expert guidance needed to navigate complex biological systems and evolving global standards.”
The ability to deliver on those promises is what sets AGC Biologics apart, and the successful collaboration with Autolus serves as a clear case study of the impact a high-performing CDMO can have on the launch of a next-generation therapy.
Strategic Impact of Regulatory Approvals for CDMO Partners
Each regulatory milestone achieved with the support of AGC Biologics not only validates the quality of its technical and operational capabilities but also strengthens the company’s position in a fiercely competitive CDMO market. In an era where cell and gene therapies represent one of the most rapidly growing segments in biotech—with projections estimating a global CGT market surpassing $25 billion by 2027—partnerships with capable, proven CDMOs have become essential to long-term commercial success.
AGC Biologics’ consistent track record across a growing portfolio of client programs reinforces its strategy to become a preferred partner for viral vector manufacturing, CAR-T cell therapy support, and gene-modified cell therapies.
The European approval of AUCATZYL® represents more than just another product on AGC Biologics’ growing roster—it reflects the maturation of a complex therapy pipeline into commercially viable products that offer new hope to patients with otherwise limited options. For Autolus Therapeutics, the greenlight opens the door to wider adoption of obe-cel across Europe, bringing this precision-engineered CAR-T therapy to patients who need it most.
For AGC Biologics, it’s a powerful affirmation of the company’s long-term investment in building cell and gene therapy manufacturing capabilities that meet and exceed global regulatory expectations.
As the global healthcare landscape continues to evolve, and as demand for personalized, high-efficacy treatments rises, CDMOs like AGC Biologics will play a pivotal role not just in delivering products, but in shaping the future of medicine.
