Back to News

Aragen Bioscience CEO talks Bangalore expansion and Indian biomanufacturing

The JP Morgan Healthcare Conference last month brought together life science experts from around the world, enabling stakeholders such as developers, contract development and manufacturing organizations (CDMOs), consultants, and regulators to gather around the shared goal of advancing the industry.

Representatives from CDMO Aragen Bioscience were among the many people in attendance. The event allowed them to conduct dozens of meetings and invite potential partners to tour the company’s facility in Morgan Hill, California, which lies about an hour south of San Francisco where the conference was held.

Aragen took the conference as an opportunity to generate buzz for its CHOMax cell-line development and manufacturing platform, which it launched at the beginning of this year. “For novel biologics, including complex formats like bispecifics and ADCs [antibody drug conjugates], CHOMax offers multiple strengths, mainly speed to IND [investigational new drug] and speed to stable clonal cell line,” said Subodh Deshmukh, CEO of Aragen Bioscience, in a conversation with BioProcess Insider. 

Aragen performs its biologics CDMO work at two major sites, one in Morgan Hill, and the other in Bangalore, India. The process begins in Morgan Hill, where the company offers discovery support for early-stage biotech and biosimilar programs. “As we move up, we can do non-GMP production and establish early processes using our CHOMax platform,” Deshmukh said.

When projects are ready for GMP production, Aragen transfers work to its Bangalore site, which is currently undergoing expansion while remaining operational. “It’s a large footprint that has total capacity of 23,000 liters,” Deshmukh told us. The facility offers Aragen scale-up flexibility, with the capability of moving from small scale all the way to 2kL.

Deshmukh said that the Bangalore facility has been designed for intensified processing, enabling the company to provide services for novel biologics, including in growing industry segments. He cited the company’s work in biosimilars, which have increasingly generated interest from developers.

Last year, the US Food and Drug Administration (FDA) announced changes to how biosimilars are regulated, pushing to accelerate development by reducing clinical testing that it has deemed unnecessary. Deshmukh told us that those changes have incentivized companies that have a need for high producing cell lines and efficient processes.

“We’ve also done a lot of work with animal health biologics, and particularly tuning cell lines for specific families of companion animals and farm animals,” Deshmukh told us.

Handling tech transfer

When we spoke with Deshmukh last summer, Aragen’s first customer had successfully transferred a program to the recently opened site in Bangalore. That number has expanded to three projects with three more transfers on the way. 

Performing tech transfer for large projects is no easy task, and Deshmukh said that he’d seen his fair share of “tech transfer nightmares” earlier in his career. He emphasized the need to have an experienced team with carefully designed systems. “We have a proven digital twin model for scale up assurance and more importantly, we have a single quality management system (QMS) across the two sites, and that allows us to move very fast and seamlessly.”

“All the data that we’re generating along the way, when we’re preparing the master cell bank (MCB), the working cell bank (WCB), doing the viral clearance studies, all of that is essentially ready to log into an IND or a biologics license application (BLA). Not only are we making the material, but we are getting the customer ready for their filing as well.”

Why India?

At a time when many companies are onshoring and investing billions of dollars in US domestic manufacturing, Aragen is going against the grain, transferring projects to India and expanding its facilities there. The Bangalore manufacturing site has enabled the company to remain flexible, thanks to a modular design that allows for easier expansion.

And according to Deshmukh, the company is currently building a fill–finish facility in Bangalore that will be operational in early 2027. That facility is being designed to serve multiple formats including pre-filled syringes, vials, and cartridges. The firm is also expanding its drug substance capacity within the next six to 12 months so that it can handle more concurrent programs, all with an eye toward commercialization.

Deshmukh said such projects are supported by a pipeline of talent that is strong in the region, stemming from the country’s academic institutions in and around Bangalore. He also said that the city is a location of choice, serving as a culturally rich multinational hub that attracts experienced workers from around the world.

“Bangalore is fast emerging as a biotech hub for the world,” he added. The city makes a comfortable home for Aragen thanks to the proximity to other biotechnology firms, including those that serve as suppliers. “We have already worked with several global equipment, media, and resin suppliers who have their tech development centers based in and around Bangalore,” Deshmukh said. “That allows us to continuously develop technology as we are also driving our platform forward.” 

Deshmukh said his work with Aragen has enabled customers to accelerate their journey through clinical trials, including with potentially first-in-class molecules that are currently undergoing study. 

“There is an overall India story which is driven by the increase in healthcare spending and increase in biologic products out of [the country,]” Deshmukh said. “And when we combine that with the advantages of Bangalore as a biotech hub, that becomes especially attractive.”

Source : BioProcess International