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Aragen talks manufacturing in Bangalore as qualification nears

Last month, BioProcess Insider had a chance to speak with Subodh Deshmukh, CEO of Biologics at Aragen Bioscience about his company’s contract development and manufacturing organization (CDMO) work in Bangalore, India and Morgan Hill, California, where he is based.

The Morgan Hill facility specializes in research and development, performing small scale early-stage bioproduction up to 50-liter batch sizes for laboratory trials. Meanwhile, the Bangalore site is a greenfield GMP facility that Deshmukh said is “custom designed and built for a state-of-the-art biomanufacturing platform.” He said the site has the latest containment technologies and process intensification capabilities.

The firm will commence its first customer program at the Bangalore site after completing qualification, which is expected to happen soon. According to Deshmukh, Aragen already has completed process and analytical development of an oncology molecule for the client which has been developed to treat pediatric indications. “It’s going to make a big difference for those kids who really need this drug,” he told us.

Aragen has been working on the project for almost a year, Deshmukh said, starting at the Morgan Hill facility, scaling it up and improving titers by about three times. “That’s a huge plus because it allows the customer to be able to get the target quantities in relatively fewer batches,” he added. “We’re very happy to be able to make that happen for them.”

Deshmukh said that if the molecule succeeds in clinical trials, Aragen is prepared to support it through commercial manufacturing.

Aragen has completed tech transfer between the Morgan Hill and Bangalore facilities for its first customer project, establishing strong reproducibility between the two sites, replicating scale results. Additionally, Deshmukh said, “We very much follow the digital twin approach, so the entire manufacturing facility is replicated digitally. We can simulate a lot before we actually [do it] so that makes this very efficient.”

He added that although it’s important to continually improve Aragen’s models, “we have already some very good models that allow us to make that transition across our sites and do that tech transfer right first time.”

Throughout its 20-plus years of existence, Aragen has worked as a boutique CDMO in the biologic space, supporting customers primarily in the US and Europe to engineer cell lines for mammalian production. “We have contributed to more than 100 INDs [Investigational New Drugs] and several commercial products use Aragen cell lines.” He praised the company for its contributions to biotech, but said that until recently, the company has not had any manufacturing capacity.

“We were essentially transferring the cell line back to the customer, and the customer would take it to a CMO for production.” Through customer conversations and market research, the firm determined that building a facility in Bangalore was the best path forward, creating a one-stop shop for customers seeking an easier journey for their biologics. “Being in India offers efficiency and better economics for our customers, and it allows us to serve the entire world,” Deshmukh said.

But what about uncertainty in the US economy? “Like everybody else, we stay in touch with government policy and how the industry is evolving,” Deshmukh explained. “What we hear from our customers is that our locations being based on shore in the US and then in Bangalore, there are really no restrictions.” Although he acknowledged the increase in US onshoring, he said Aragen remains bullish on its facility in India. “We’ve worked with 15 of the top 20 Big Pharma [firms] as well as many mid-sized pharma and bio-pet companies.”

Aragen is also insulated from any fallout that could occur from the BIOSECURE Act, which targets Chinese companies specifically, and if passed, will impact their business in the US. “We do hope that BIOSECURE can be a tailwind, and we could be part of that solution,” Deshmukh said.

Aragen recently announced the appointment of Aniel Khubchandani as its CEO of Development and Manufacturing Solutions business. Upon his appointment, Khubchandani said, “I am excited to join Aragen and lead its development and manufacturing business. Globally, there is an increasing focus on outsourcing, especially in the late phase and commercial manufacturing space.”

Source: BioProcess International