The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.
Bioreactor. Cultivation of microorganisms in the bioreactor. Laboratory fermenter. Microbial fermentation. The creation of drugs. Microbiology. Biotech industry. Pharmacology. | Image Credit: © Grispb - stock.adobe.com
Aragen, a contract research, development, and manufacturing organization (CRDMO) headquartered in India, is planning to commence good manufacturing practice (GMP) manufacturing at its biologics manufacturing facility in Bangalore, India in late July 2025 (1). That announcement, made in a June 12, 2025 press release in advance of the opening of the 2025 Biotechnology Innovation Organization (BIO) International Convention, follows the successful completion of facility and equipment qualifications that the company said demonstrated its intensified fed batch cell culture manufacturing platform.
The productivity of that platform has been proven to deliver titers greater than 25 g/L, Aragen said, and the Bangalore facility has the flexibility to house multiple single-use 2-KL bioreactors—which are set up for both fed batch and intensified fed batch production—delivering one batch every four to five days at full capacity (1).
“The Aragen team has delivered a state-of-the-art facility to enable industry leading COGS [cost of goods sold] and quality,” Subodh Deshmukh, Aragen CEO, Biologics and President, Development, said in the release (1). “Our first customer program will progress to GMP production as early as late July this year. The Bangalore manufacturing facility will help seamless transition to GMP manufacturing using not only intensified fed batch production, but also, our proprietary high-yield CHO-GS and CHO-DG44 cell lines.”
The 2-KL bioreactors, according to the press release, are capable of feeding into a single downstream purification suite, providing flexibility to either run multiple client projects at once, or scale a customer’s production up to commercial quantities very quickly (1). Along with Aragen’s United States-based biologics campus in Morgan Hill, Calif., these facilities will offer integrated services ranging from cell line development to process and analytical development, as well as quality control and GMP manufacturing of monoclonal antibodies and biosimilars.
"The biologics manufacturing facility in Bangalore marks a significant milestone in Aragen's evolution as an integrated, end-to-end solutions provider,” Jamie Cascio, AVP, Biologics, said in the release (1). “With cutting-edge infrastructure and deep technical expertise under one roof, this facility is designed to seamlessly support our partners from early discovery through to commercial manufacturing. It strengthens our ability to offer speed, scalability, and compliance—enabling our customers to accelerate the journey of their biologics molecules to market with confidence."
The Bangalore site was first announced in October 2023, when Aragen said it would be making a $30 million investment into biologics manufacturing there (2). The start of GMP manufacturing there is timely, as in February 2025, a report from Boston Consulting Group and Innovative Pharmaceutical Services Organization suggested that the CRDMO sector in India has the potential to grow to between $22 billion and $25 billion by the year 2035 (3).
"The shift in global pharma outsourcing, the rapid rise of biologics, and India’s expertise in chemistry and process innovation create a once-in-a-generation opportunity,” Manni Kantipudi, CEO and whole-time director of Aragen Life Sciences Ltd., said at the time (3). “However, to compete at a global level, Indian CRDMOs must not only scale capabilities in new modalities like ADCs [antibody-drug conjugates], cell and gene therapies, and RNA therapeutics but also work together to build a resilient supply chain and streamline regulatory pathways.”
Aragen said several of its developed cell lines, like the ones that will be in production at the Bangalore facility, are now in use for the manufacture of marketed products in the US and around the world (1).
1. Aragen. Aragen’s Biologics Manufacturing Facility Completes Qualification; First GMP Batches in Late July 2025. Press Release. June 12, 2025.
2. Aragen. Aragen Setting Up a $30 Million Biomanufacturing Site in India. Press Release. Oct. 30, 2023.
3. Aragen. India’s CRDMO Sector Growth Potential at $22–$25 Billion by 2035, Driving Global Pharma Innovation: BCG-IPSO Report. Press Release. Feb. 22, 2025.
