AGC Biologics positions itself as ‘friendly’ CDMO as new CEO plots course for 2025

Seattle-based AGC Biologics, a global CDMO with more than 30 years of experience serving the biopharma industry, has a new CEO and is taking a “friendly” business approach as it looks to be a collaborative, reliable, and stable partner for its customers in 2025 and beyond.

CEO Alberto Santagostino, who took the helm of AGC Biologics in November 2024 after serving as Lonza’s head of cell and gene technology (CGT), contends that this year the general business environment for the biopharma sector is “starting to pick up a little bit,” while customers are more discerning when it comes to seeking out partners for CDMO services backed by strong expertise in science and engineering.  

“Before, everybody was getting money without good judgment of the backing science. Now, for the most, money is where good science is,” Santagostino told Pharma Manufacturing. “The growth is not going to be as big as before but it’s getting better than what it was in the recent past.”

In 2025, Santagostino sees a “rational realism” emerging among biopharma customers when dealing with CDMOs after years of both irrational exuberance and pessimism. With CGT overcapacity in the CDMO manufacturing environment, he sees it as a “buyers’ market” as customers become more selective in contracting services.

Biopharma customers are looking for partners that are financially solid with a track record of success and technical expertise, according to Santagostino, who predicts a “rebalancing” in the market that will include several CDMOs going out of business amid the challenging environment. 

Over three decades, AGC Biologics claims to have served more than 250 customers on over 400 projects, with more than 90 successful regulatory inspections and 25 commercial products launched — including lentiviral vectors for a CAR-T therapy from Autolus Therapeutics and a gene therapy from Orchard Therapeutics.

“It’s still a high, intense knowledge business,” Santagostino said. “It’s an art and a science” in providing development and manufacturing services for protein-based biologics and CGTs, he noted, and “we lean on our talent” which includes more than 2,500 employees working at seven facilities in three continents.

Under his leadership, Santagostino said AGC Biologics will look to differentiate itself from other CDMOs with friendly/expert services to the biopharma industry designed to be a “safe harbor” for customers seeking to minimize geopolitical risks, intellectual property concerns, steep price expectations, as well as transactional or confrontational supplier relationships.

At the same time, the company will continue to provide end-to-end global CDMO services in Europe, Japan, and the United States, as it looks to grow capacity. In addition to its U.S. facilities in Seattle and Boulder and Longmont, Colorado, AGC Biologics has production and manufacturing centers in Copenhagen, Denmark, Heidelberg, Germany, Milan, Italy, and Chiba, Japan.

Italy center of excellence, plans for Japan

Santagostino pointed to AGC’s Milan site, which has been authorized by both the FDA and EMA for viral vector and cell therapy production, as a center of excellence for CGT supporting nine commercial products, which he contends is more than any other site in the world.

“My problem is the market doesn’t know it,” Santagostino said. The company also claims that its Milan facility was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

Earlier this month, AGC Biologics announced that it signed an agreement with Adaptimmune to manufacture the lentiviral vector for lete-cel, a cell therapy targeting solid tumor antigen NY-ESO-1. The Milan site will handle process characterization, stability studies, and supply vectors to support regulatory submissions for lete-cel.

This month, Genenta Science expanded its partnership with AGC Biologics by securing an exclusive GMP suite in Milan, which will support the production of Genenta’s cell therapy for solid tumors Temferon. Separately, AGC Biologics this month also announced a partnership with Pandorum to produce Kuragenx, a biologic designed to treat advanced neurotrophic keratitis, with the Milan facility overseeing the scale-up and production of pharmaceutical-grade exosomes for the therapy.

Thanks to a grant from the Japanese Ministry of Economy, Trade and Industry, AGC Biologics announced plans last year for a new $350 million manufacturing site in Yokohama, Japan, which will be operational in 2026 and feature mammalian cell culture, messenger RNA and cell therapy services with multiple 2,000L single-use bioreactors and several 4,000L or larger reactors. The company claims that when the Yokohama facility is completed it will be one of Japan’s largest sites for mammalian-based manufacturing capacity.

According to Santagostino, there is an unmet domestic demand that needs to be addressed in Japan. AGC Biologics “wants to become the CDMO of reference” in the Asian country, he said. The Yokohama site will serve Japan’s biopharma companies and those foreign firms that “want to take advantage of the Japanese quality of manufacturing and the cost advantage of a pretty weak yen,” Santagostino added.

Japan’s Fujifilm Corporation is building the company’s first Japanese bio-CDMO facility in Toyama City. The new site, which will be operational in fiscal year 2026, will include dual-use facilities capable of manufacturing antibody drugs and antibody-drug conjugates and switching to the manufacture of mRNA vaccines and genetically-engineered protein vaccines.

However, Santagostino argues that AGC Biologics “is going to be the only meaningful player in Japan.” When the company’s Yokohama site comes online, he said it will likely be the largest site for disposable bioreactor manufacturing.