Aragen has rolled out CHOMax, a new biologics development platform aimed at shortening the timeline from DNA to IND-enabling clinical supply to about 10 months for standard IgG monoclonal antibody programmes.
The platform brings together cell line development, process development, analytics, GMP drug-substance manufacturing and drug-product support into a single, royalty-free pathway. Unlike many proprietary systems, CHOMax allows sponsors to retain full ownership of their cell lines, with no platform royalties or downstream fees, protecting the long-term value of their assets.
CHOMax is built on Aragen’s CHO host lineage, which has been refined through more than 200 development programmes. In internal performance benchmarks, many IgG molecules have reached around 8 g/L at the clonal stageand up to 27 g/L after process optimisation under intensified conditions, depending on the antibody.
The platform has been structured to meet FDA, EMA and PMDA regulatory expectations, with key CMC activitiesdesigned to run in parallel where possible. This approach is intended to reduce development risk, avoid late-stage rework and improve predictability in early biologics programmes.
Development speed is driven by early pool-based process development, in-house Master Cell Bank generation, early developability screening, and parallel planning for GMP manufacturing readiness. Programmes follow pre-defined workflows and phase-appropriate development gates to keep timelines and data packages aligned with regulatory requirements.
A standard CHOMax programme produces a clonal research cell bank in about 16 weeks, moving through vector construction, transfection, pool screening, single-cell cloning and clone characterisation. Analytical methods, method qualification and MCB creation are carried out within Aragen’s biologics network, while GMP drug-substance production is performed under global quality systems. Drug-product manufacturing for first-in-human studies is handled through qualified partner facilities.
Over the past three years, Aragen’s biologics network has supported more than 222 regulatory and client audits, delivering CMC data packages designed for inclusion in IND and CTA submissions. The CHOMax platform is now open for new development programmes.
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