- Aragen has launched CHOMax™, a cell line development and early manufacturing platform designed to support DNA-to-IND-enabling clinical supply in approximately 10 months for suitable standard IgG antibodies.
- The platform integrates development and GMP manufacturing activities under a royalty-free model aligned with global regulatory expectations.
Aragen has launched CHOMax™, a new cell line development and early manufacturing platform intended to support an integrated path from DNA to IND-enabling clinical supply in around 10 months for suitable standard IgG monoclonal antibodies. The platform is designed to provide a structured development pathway, covering both drug substance and drug product support within a contract manufacturing framework.
According to the company, CHOMax™ has been refined across more than 200 CHO programmes and brings together cell line development, process development, analytics and GMP manufacturing. Activities are performed under quality processes intended to meet global regulatory expectations, including those of the FDA, EMA and PMDA. Where appropriate, key CMC activities can run in parallel to reduce rework risk and timeline uncertainty.
“CHOMax™ gives sponsors a clearly structured pathway to IND-enabling clinical supply, together with a royalty-free model that keeps control with the innovator.”
Subodh Deshmukh, CEO of Aragen Biologics
Client programmes using CHOMax™ 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 creation, early developability assessment and parallel GMP readiness planning.
Aragen stated that its biologics network has completed 222 regulatory and client audits over the past three years, with CMC data packages and documentation designed to integrate directly into sponsor IND or CTA submissions. CHOMax™ is now available for new programme starts as part of the company’s CDMO and contract manufacturing services.
