For Astellas’ chief manufacturing officer, Rao Mantri, Ph.D.—who entered the position a little over a year ago—production is not just about a reliable supply of a pharmaceutical product. Manufacturing serves as a crucial bridge that helps link promising research to patients in the real world, too.
“Astellas manufacturing has tremendous strengths in multiple modalities as well as a strong focus on service to patients,” Mantri said during a recent meeting with Fierce at the American Biomanufacturing Summit in San Francisco. “So, when I started, it was about—how do we actually make the manufacturing organization as a strategic enabler to connect research innovation to access to patients even more.”
He described that ambition under his leadership as Astellas’ manufacturing “north star," alongside always ensuring a reliable supply of its medicines.
When Mantri entered the role of manufacturing chief at the Tokyo-headquartered pharma last April, he came in with the goal of helping streamline new modalities for manufacturing and commercial supply and of embedding digital and artificial intelligence tools into Astellas’ network, he explained.
Over the past few years, the company has made several strategic moves to help broaden its production base in advanced treatment fields such as cell therapy and antibody-drug conjugates.
On the balance between Astellas’ internal and external capacity, Mantri noted that it’s critical to weigh multiple factors, including speed to patients, modality complexity, development stage, regulatory readiness and cost competitiveness when drawing up a supply plan.
“But what’s most important is really about our ability to deliver the reliable supply,” he explained, adding that the company benefits from working with CDMOs and other partners whose capabilities may fall outside of Astellas’ core wheelhouse.
“We also have platform approaches that we are ready to partner with the right strategic groups,” Mantri added, citing a recent pact with Yaskawa Electric Corporation.
In the case of that Yaskawa joint venture, Astellas is wedding its regenerative medicine expertise and manufacturing base with its partner’s robotics and AI capabilities.
The purpose of the team-up is to develop a robotic automation platform that other companies can also use to produce medicines faster with superior quality and reliability, while also accelerating technical development, according to Mantri.
Separately, Astellas last Halloween tied up with Ajinomoto to use the latter's bespoke antibody-drug conjugate (ADC) development and manufacturing platform, AJICAP, which Mantri noted will help Astellas “design the next generation” of ADCs.
“It’s really based on where do we want to go and what are the capabilities that we can leverage that are not internal to us,” Mantri said. “We are ready to partner, but if you have the maturity in our platforms that others can use, we are open to having those strategic collaborations as well.”
With regard to internal capacity, one of Astellas’ most prominent expansions has taken the form of a new plant in Tralee, County Kerry, Ireland, which the company first unveiled designs for in 2023.
External construction on the fill and finish facility—which will use advanced manufacturing and testing to deliver parenteral biologics—has wrapped up, with the site now expected to open in “early 2027,” per Mantri.
Mantri also addressed geopolitical tensions—primarily in the form of U.S. import tariffs—that have complicated production decision-making in recent months.
Astellas, in his estimation, is relatively well positioned given the company’s “geographically balanced global production network.”
He also pointed to the company’s established manufacturing base in the U.S., where Astellas boasts a gene therapy production site in North Carolina and a unit for cell therapy manufacturing in Massachusetts, the latter of which has “strong capabilities for future regenerative medicines.”
Looking at the role of Astellas’ manufacturing network, and the position production holds in the biopharma landscape more broadly, Mantri described the manufacturer’s charge as twofold: Production teams must both work to help streamline innovation coming out of research and “embrace and take into consideration uncertainties and complexities to serve patients” and provide reliable access to medicines.