AGC Biologics to Expand Gene and Cell Therapy CDMO Capacity at its Milan Site
―Filling the growing demand for viral vector CDMO services―
AGC (AGC Inc.; Headquarters: Tokyo; President: Yoshinori Hirai), a world-leading manufacturer of glass, chemicals, and high-tech materials, has announced that the company decided to expand the capacity for gene and cell therapy at its biopharmaceutical CDMO*1 subsidiary, AGC Biologics S.p.A. (Headquarters: Milan, Italy). At its Milan site Bresso Plant, AGC Biologics will install new viral vector*2 production equipment and will enhance its analytics and process development facilities. The new facilities are scheduled to begin full operation in 2022. Further expansion is also being considered.
Gene and cell therapy is one of the most advanced medical treatments, with remarkable advances currently being made. Approximately 1,000 clinical trials are currently underway around the world. The related CDMO market is accordingly expected to grow by more than 30% annually*3. Acquired by AGC in July 2020, AGC Biologics S.p.A. (formerly named Molecular Medicine S.p.A.) has strong technologies, such as for cell processing and viral vector manufacturing, to offer GMP*4 compliant gene and cell therapy CDMO services to various customers, from biotech ventures to major biopharmaceutical companies. The equipment being installed will enable the company to implement viral vector suspension*5 capabilities, a production platform suitable for larger scale manufacturing of viral vectors.
Under its AGC plus 2.0 management policy, AGC Group has positioned its Life Science business including its biopharmaceutical CDMO services, as one of its strategic businesses. The Group has been expanding its business through multiple acquisitions and capital investments in biopharmaceutical CDMO services using mammalian cells and microorganisms, as well as in synthetic pharmaceutical and agrochemical services. Furthermore in 2020, the Group expanded the scope of its CDMO business into the rapidly growing field of cell and gene therapies. The sales target for the Group’s Life Science business is 180 billion yen or more for 2025.
The AGC Group will continue to work with the pharmaceutical companies, contributing to the well-being of patients and society, by maximizing the synergy of each site so that the Group can provide its customers in each region with globally unified, high-quality services.
Notes: *1 CDMO: Contract Development & Manufacturing Organization. A company which is contracted on behalf of another company to serve product manufacturing as well as the development of manufacturing processes. *2 Viral vector: A vector is used to carry the target gene into a cell. Among vectors, viral vectors are those using modified cultured viruses. *3 30% or higher annual growth: CAGR from 2020 to 2024. AGC estimate based on EvaluatePharma® World Preview 2017, Outlook to 2022 and other sources. *4 GMP: Good Manufacturing Practice. A standard for the manufacture and quality management of pharmaceutical products. *5 Suspension platform: A culture method used in the manufacture of viral vectors in which cells are free-floating in the culture media. It enables culturing on a larger scale compared with the adherent method, in which cells are attached to a substrate.