Highlights
- ~8 g/L at clonal stage for many standard IgG programs
- ~27 g/L after optimization under intensified conditions (molecule-dependent)
- Refined across 200+ CHO programs
- Royalty-free model: sponsors own the cell line, with no platform royalties or back-end fees
“IND-enabling clinical supply refers to GMP drug substance plus drug product support for first-in-human dosing through qualified partners.”
Why CHOMax™
Why sponsors use CHOMax™
CHOMax™ is designed for sponsors advancing standard antibodies toward first-in-human studies on accelerated timelines. It turns Aragen’s CHO experience into a repeatable, stage-gated platform for taking suitable standard IgG programs from DNA to IND-enabling clinical supply in ~10 months. It combines:
- Early, parallel CMC execution where scientifically appropriate
- Platform analytics and defined decision points
- A royalty-free commercial model that protects long-term value
Speed, with clear decision points
CHOMax™ programs are planned as one integrated workflow from the start: cell line development, process development, analytics, and GMP readiness activities run in parallel where appropriate, guided by clear stage gates and pre-agreed decisions.
The goal: reduce calendar time and reduce rework risk.
Royalty-free economics
CHOMax™ is offered on a transparent fee-for-service basis. Sponsors own the CHOMax™-derived cell line and associated data package, with no platform royalties or back-end fees.
Built on real CHO experience
CHOMax™ has been refined across 200+ CHO programs, combining platform learning with a structured execution model designed for first-in-human timelines.
“Other molecule formats may be evaluated case-by-case.”
How CHOMax™ Works
How CHOMax™ compresses the timeline
CHOMax™ uses an overlapping, stage-gated design. Activities progress in parallel rather than waiting in strict sequence, while critical decisions remain gated by data.
A typical integrated program includes:
1) CLD to clonal RCB (about 16 weeks)
A structured workflow covering vector design, transfection, pool screening, single-cell cloning, and clone characterization to generate a fully characterized clonal research cell bank (RCB).
2) PD and analytics in parallel
Once lead clones are identified, phase-appropriate process development, analytical method development, and GMP readiness planning begin in parallel, guided by pre-defined decision points.
3) In-house MCB and GMP drug substance
Master Cell Bank (MCB) creation, method qualification, and GMP drug substance manufacturing are executed within Aragen’s integrated network. Drug product for first-in-human dosing is supported through qualified partners.
What “~10 months” assumes
A ~10-month path is most achievable when scope is aligned early and sponsor inputs and decisions are timely.