AGC Biologics Launches Cellular and Genetic Technologies Division to Boost Nine Market-Approved Products
AGC Biologics, a leading Contract Development and Manufacturing Organization (CDMO), has announced the creation of its new Cell and Gene Technologies division. This strategic move is designed to strengthen the company’s existing capabilities and solidify its position as a trusted, experienced partner in the advanced therapies sector, focusing particularly on cell and gene therapies.
Despite challenges faced by the industry, including closures of facilities and workforce reductions by other companies, AGC Biologics remains committed to expanding its services. The new division leverages the company’s established global development and manufacturing network, which spans Milan, Italy; Longmont, Colorado, USA; and Yokohama, Japan. AGC Biologics also offers proprietary cell therapy and viral vector platforms, such as ProntoLVV™ and BravoAAV™, which help developers achieve rapid GMP (Good Manufacturing Practice) compliance while maintaining cost control.
The new division will be led from AGC Biologics’ Cellular and Genetics Center of Excellence in Milan, a site with over 30 years of experience in cell and gene therapy. The Milan facility has a solid track record, including nine commercial approvals and hundreds of successful GMP lot productions. This expertise has allowed AGC Biologics to partner closely with customers and ensure the successful clinical, late-stage, and commercial outcomes of their products.
In the past 12 months, the Milan facility has seen significant growth, securing two FDA market approvals for products such as Lenmeldy™ and Aucatzyl®. The site has also experienced organic growth of over 20% despite an overall downtrend in the industry. With new agreements in place for viral vector services, autologous and allogeneic cell therapy, and even an exosome project, the Milan site is reaffirming its leadership position in the field.
The 13,000 m² Milan facility offers end-to-end services, including innovation and research and development (R&D) teams that support early-stage clinical development. Expanded viral vector suites of up to 2,000L and dedicated cell therapy suites enable AGC Biologics to provide a secure path from Investigational New Drug (IND) applications to commercialization. The site has already supported the successful development of five viral vectors and four cell therapy products, underscoring its capabilities to handle late-stage and commercial manufacturing challenges.
In addition to Milan, AGC Biologics is also expanding its global capabilities with the upcoming inclusion of the Longmont, Colorado, USA and Yokohama, Japan facilities. The Yokohama facility will begin cell therapy operations in July 2025, further enhancing AGC Biologics’ global network.
The goal of the new Cell and Gene Technologies division is to drive advancements in cell and gene therapies, an area of significant promise in treating various diseases. By focusing on R&D initiatives, addressing clinical-stage complexities, and developing scalable manufacturing processes, the division aims to support the needs of developers worldwide. The division’s core mission is to collaborate with developers to bring life-saving therapies to patients around the globe.
Luca Alberici has been appointed Executive Vice President of the Cellular and Genetic Technologies Division. Alberici will report to Alberto Santagostino, President and CEO, and will oversee the global strategy, operations, and business development of the new division. He will continue in his role as General Manager of the Cellular and Genetic Center of Excellence in Milan, where his leadership and industry expertise will be pivotal to the division’s success.
With 20 years of experience in the cell and gene therapy industry, Alberici is a highly respected figure in the field. His track record in bringing CGT products to market, along with his long-standing relationships with clients, positions him to lead the division’s global efforts effectively. According to Alberto Santagostino, Alberici’s extensive leadership experience and deep industry knowledge will be essential as AGC Biologics expands its capabilities and client base in this critical therapeutic area.
“AGC Biologics has made significant investments to ensure the economic viability of cell and gene therapy production,” said Alberici. “We are now focused on making life-saving treatments more affordable. By achieving new production scales, we aim to provide lentiviral vectors for commercial applications at a cost of less than $1,000 per patient. With automation in cell therapy manufacturing, in-house quality control testing, and a global network, we are ready to be the partner of choice for late-stage cell therapy developers.”
AGC Biologics’ new division will also focus on viral vectors, CAR-T therapies, and innovative approaches like exosomes. The company’s goal is to continue making meaningful contributions to the global cell and gene therapy landscape and ensure that these transformative therapies reach more patients worldwide.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical contract development and manufacturing organization (CDMO). With a strong commitment to the highest standards of service, AGC Biologics partners with clients to provide accessible, expert services across a wide range of therapeutic modalities. The company offers world-class development and manufacturing of therapeutic proteins, plasmid DNA (pDNA), mRNA, viral vectors, and genetically modified cells. AGC Biologics has a global presence with facilities in the United States, Europe, and Asia, and employs over 2,800 team members worldwide. AGC Biologics is part of the Life Sciences division of AGC Inc., a global leader in biopharmaceuticals, advanced therapies, and small molecule active pharmaceutical ingredients.
