Aragen Biologics launched CHOMax™, a new cell line development and early manufacturing platform that the company says supports an integrated path from DNA to IND-enabling clinical supply for suitable standard IgG monoclonal antibodies.
CHOMax has been refined across 200+ CHO programs and integrates cell line development, process development, analytics, and GMP manufacturing under quality processes designed to meet global regulatory expectations including FDA, EMA and PMDA, according to Subodh Deshmukh, CEO, Aragen Biologics, adding that CMC activities can run in parallel where appropriate.
Client programs using CHOMax follow platform-defined workflows and phase-appropriate practices across the development lifecycle, notes Ashu Tandon, COO.
“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,” he says.
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, explains Tandon. 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.
He points out that analytical development, method qualification and Master Cell Bank (MCB) creation are executed within Aragen’s biologics network and states that 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 is now available for new program starts, says Subodh Deshmukh.
