Aragen Launches CHOMax for Fast DNA to IND Clinical Supply

Aragen Biologics has launched CHOMax, a cutting-edge cell line development and early manufacturing platform designed to accelerate monoclonal antibody programmes from DNA to IND-enabling clinical supply in approximately 10 months. The royalty-free platform offers biotech and pharma partners a clearly defined development pathway with support for both drug substance and drug product.

Subodh Deshmukh, CEO of Aragen Biologics, said, “CHOMax gives sponsors a clearly structured pathway to IND-enabling clinical supply, together with a royalty-free model that keeps control with the innovator. In fact, innovators select Aragen because they need predictable execution, clear decision points, and economics that protect long-term value.”

Refined through more than 200 CHO programmes, CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes aligned with global regulatory standards, including FDA, EMA, and PMDA. The platform allows key CMC activities to run in parallel, reducing rework and timeline uncertainties.

Ashu Tandon, chief commercial officer at Aragen, added, “Our proprietary CHOMax platform takes uncertainty out of early biologics development. By combining a proven CHO host lineage, time-tested CMC workflows, and royalty-free financial model, Aragen moves antibody programmes from DNA to IND-enabling clinical supply in a matter of months, generating sustainable value for our customers.”

Typical CHOMax programs include generating a clonal research cell bank (RCB) in 16 weeks, with stage gates for vector design, transfection, pool screening, single-cell cloning, and clone characterization. Phase-appropriate process development, analytical method development, and GMP campaign planning are then run in parallel, guided by pre-agreed decision points.

Aragen’s biologics network, which has completed 222 regulatory and client audits in the last three years, ensures CMC packages and documentation support are fully ready for integration into sponsor IND or CTA submissions. CHOMax is now available for new program starts.