Aragen launches CHO platform to accelerate DNA-to-IND biologics supply

India-based Aragen, with U.S. headquarters in Morgan Hill, California, has launched a CHO-based platform designed to move standard IgG monoclonal antibody programs from DNA to IND-enabling clinical supply in roughly 10 months. The company said the platform provides a royalty-free pathway that allows sponsors to retain ownership of the cell line, while integrating drug substance and drug product support through qualified partners.

Refined across more than 200 CHO programs, the platform combines cell line development, process development, analytical workflows, and GMP manufacturing under global regulatory quality standards, according to the announcement. Key chemistry, manufacturing, and control activities can run in parallel where appropriate to reduce timeline uncertainty and minimize rework risk.

“Innovators select our services because they need predictable execution, clear decision points, and economics that protect long-term value,” Aragen CEO Subodh Deshmukh said in a statement. “The platform gives sponsors a clearly structured pathway to IND-enabling clinical supply, together with a royalty-free model that keeps control with the innovator.”

Programs using the platform typically include creation of a clonal research cell bank in about 16 weeks, followed by lead clone selection, phase-appropriate process development, analytical method development, and GMP campaign planning running in parallel. GMP drug substance manufacturing is conducted under quality processes designed to meet FDA, EMA, and PMDA expectations, with drug product support provided through qualified partners, the company said.

“Our platform takes uncertainty out of early biologics development,” Aragen Chief Commercial Officer Ashu Tandon said in a statement. “By combining a proven CHO host lineage, time-tested workflows, and a royalty-free financial model, we move antibody programs from DNA to IND-enabling clinical supply in a matter of months, generating sustainable value for our customers.”

The company contends that its network has completed 222 regulatory and client audits over the past three years, providing phase-appropriate CMC data and documentation designed to integrate directly into sponsor IND or CTA submissions. The platform is now available for new program starts.