Aragen launches CHOMax™ reducing DNA to clinical supply to 10 months

New Delhi: Aragen launches CHOMax™, a new cell line development and early manufacturing platform that supports an integrated path from DNA to IND-enabling clinical supply in ~10 months* for suitable standard IgG monoclonal antibodies. This accelerated, royalty-free approach provides biotech and pharma partners with a clearly structured development pathway, including both drug substance and drug product support.

CHOMax^TM – which has been refined across 200+ CHO programs – integrates cell line development, process development, analytics, and GMP manufacturing under quality processes designed to meet global regulatory expectations including FDA, EMA and PMDA. Crucially, key CMC activities can run in parallel where appropriate, reducing avoidable rework risk and timeline uncertainty.

“Innovators select Aragen because they need predictable execution, clear decision points, and economics that protect long-term value” Subodh Deshmukh, CEO, Aragen Biologics commented.

“CHOMax^TM gives sponsors a clearly structured pathway to IND-enabling clinical supply, together with a royalty-free model that keeps control with the innovator.”

Client programs using CHOMax^TM follow platform-defined workflows and phase-appropriate practices across the development lifecycle. Speed is driven by early process development starting from pools, in-house Master Cell Bank (MCB) creation, early developability assessment, and parallel GMP readiness planning.

Ashu Tandon, Chief Commercial Officer, 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 programs from DNA to IND‑enabling clinical supply in a matter of months, generating sustainable value for our customers.”

Typical integrated CHOMax™ programs include generation of a clonal research cell bank (RCB) in ~16 weeks, with stage gates for vector design, transfection, pool screening, single-cell cloning and clone characterization. Once lead clones are identified, phase-appropriate process development, analytical method development and GMP campaign planning run in parallel, guided by pre-agreed decision points. Analytical development, method qualification and Master Cell Bank (MCB) creation are executed within Aragen’s biologics network. GMP drug substance manufacturing is performed under quality processes designed to meet global regulatory expectations, with drug product support for first-in-human dosing provided through qualified partners.

Aragen’s network has completed 222 regulatory and client audits over the last three years, with phase-appropriate CMC data packages and documentation support designed to integrate directly into sponsor IND or CTA submissions. CHOMax^TM is now available for new program starts.