Aragen Biologics launched CHOMax, a new platform that cuts DNA-to-IND timelines for standard IgG monoclonal antibodies to around 10 months, integrating cell line development and early manufacturing for faster clinical supply. 

 

The royalty-free platform offers biotech and pharma partners a fully integrated development pathway, including both drug substance and drug product support.

 

Refined through more than 200 CHO programs, CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes that meet global regulatory expectations, including FDA, EMA, and PMDA. By enabling key CMC activities to run in parallel where appropriate, Aragen reduces rework risks and eliminates timeline uncertainty.

 

“Innovators select Aragen because they need predictable execution, clear decision points, and economics that protect long-term value,” said Subodh Deshmukh, CEO, Aragen Biologics. “CHOMax 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 follow platform-defined workflows and phase-appropriate practices across the development lifecycle. Speed is achieved through early process development from pools, in-house Master Cell Bank (MCB) creation, early developability assessment, and parallel GMP readiness planning.

 

“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,” said Ashu Tandon, Chief Commercial Officer, Aragen.

 

Typical CHOMax programs generate a clonal research cell bank (RCB) in roughly 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 under pre-agreed decision points. 

 

Analytical development, method qualification, and MCB creation are executed across Aragen’s biologics network, while GMP drug substance manufacturing and first-in-human drug product support are provided through qualified partners, all under rigorous global quality standards.