For Astellas Pharma Chief Manufacturing Officer Dr. Rao Mantri, who has been in the role for just over a year, production is about more than just ensuring a reliable supply of medicines. Manufacturing also serves as a critical bridge connecting promising research to patients in the real world.
“Astellas Pharma’s manufacturing business is not only focused on serving patients, but we also have tremendous strength in multiple modalities,” Mantri said during a recent meeting with Fiers at the American Biomanufacturing Summit in San Francisco. “So the challenge when I started was how do you actually create a manufacturing organization as a strategic enabler to connect research innovation to more patient access?”
He described that ambition under his leadership as Astellas’ manufacturing “north star.” always ensure We ensure a reliable supply of medicines.
When Mantri took on the role of head of manufacturing at the Tokyo-headquartered pharmaceutical company last April, he explained that he came on board with the goal of helping streamline new avenues for manufacturing and commercial supply, and helping to incorporate digital and artificial intelligence tools into Astellas’ network.
Over the past few years, the company has taken several strategic steps to help expand its production base in advanced therapeutic areas such as cell therapy and antibody-drug conjugates.
Regarding the balance between Astellas’ internal and external capabilities, Mantri noted that it is important to weigh multiple factors when planning supply, including speed of delivery to patients, complexity of modality, stage of development, regulatory readiness, and cost competitiveness.
“But the most important thing is our ability to actually provide reliable supply,” he explained, adding that the company benefits from working with CDMOs and other partners that have capabilities outside of Astellas’ core command center.
“We also have a platform approach where we are ready to partner with the right strategic groups,” Mantri added, citing a recent agreement with Yaskawa Electric.
In its joint venture with Yaskawa Electric, Astellas is combining its regenerative medicine expertise and manufacturing footprint with its partner’s robotics and AI capabilities.
Mantri said the team-up’s aim is to accelerate technology development while developing a robotic automation platform that can be used by other companies to produce medicines faster with superior quality and reliability.
Separately, Astellas partnered with Ajinomoto Co. last Halloween to utilize Ajinomoto’s custom antibody-drug conjugate (ADC) development and manufacturing platform AJICAP. Mantri noted that this will help Astellas Pharma in its “next generation design” of ADCs.
“It’s really based on where we want to go and what capabilities we can leverage that we don’t have internally,” Mantri said. “We are open to partnerships, but if your company has a mature platform that others can use, we welcome strategic partnerships.”
In terms of internal production capacity, one of Astellas Pharma’s most significant expansions will take the form of a new factory in Tralee, County Kerry, Ireland, the design of which the company first announced in 2023.
External construction of the fill and finish facility, which will utilize state-of-the-art manufacturing and testing to deliver parenteral biologics, has been completed and the site is expected to open in “early 2027,” Mantri said.
Mantri also cited geopolitical tensions, primarily U.S. import tariffs, that have complicated production decisions in recent months.
In his assessment, Astellas Pharma is in a relatively advantageous position given its “geographically balanced global production network.”
He also pointed to Astellas’ established manufacturing footprint in the U.S., noting that Astellas boasts a gene therapy manufacturing site in North Carolina and a cell therapy manufacturing unit in Massachusetts, the latter with “strong capabilities for future regenerative medicine.”
Looking at the role of Astellas’ manufacturing network and its place in the broader biopharmaceutical industry, Mantri explained that the manufacturer’s responsibility is two-fold. Production teams will need to both strive to help streamline innovation emerging from research and “embrace and account for uncertainty and complexity to serve patients” and provide reliable access to medicines.
