AGC Biologics has established a new Cell and Gene Technologies Division, appointing Luca Alberici as executive vice president to lead global strategy, operations, and commercial development.
The new division will operate from AGC’s Milan, Italy site, which serves as the company’s Cell and Gene Center of Excellence. Alberici will continue to serve as general manager of the center and report directly to CEO Alberto Santagostino.
The 140,000-square-foot Milan facility offers end-to-end services, including early-phase R&D support, large-scale viral vector production, cell therapy manufacturing, and in-house quality control. The site holds FDA and EMA approvals and has supported nine commercial products to date, including recent approvals for Lenmeldy and Aucatzyl.
AGC’s expanded division also includes facilities in Longmont, Colorado, and a new site in Yokohama, Japan, scheduled to begin cell therapy operations in July 2025. The global footprint is intended to support clinical and commercial developers with scalable manufacturing and region-specific needs amid broader industry contraction.
In addition to its U.S. facilities in Seattle and Boulder, Colorado, AGC has production and manufacturing centers in Copenhagen, Denmark, Heidelberg, Germany, and Chiba, Japan.
“AGC Biologics has invested significant resources to make manufacturing of cell and gene therapies economically sustainable for the market,” Alberici said in a statement. “With our newest scales, we are focused on making life-saving treatments more cost-effective and aim to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient.”
Alberici, who has 20 years of experience in the field, will oversee the division’s growth and integration of AGC’s proprietary platforms, including ProntoLVV and BravoAAV, which are designed to support faster and more cost-effective transitions to GMP manufacturing.
Santagostino, who took the helm of AGC in November 2024, told Pharma Manufacturing earlier this year that he is looking to differentiate the company from other CDMOs serving the biopharma industry. He sees AGC as a “safe harbor” for customers seeking to minimize geopolitical risks, intellectual property concerns, steep price expectations, as well as transactional or confrontational supplier relationships.