Aragen has completed the technology transfer and first commercial-scale GMP manufacturing runs for Renaissance Pharma’s lead monoclonal antibody, Daretabart, marking a major acceleration in the programme’s clinical and commercial readiness.
The humanised anti‑GD2 antibody, developed for high-risk neuroblastoma, received Fast Track Designation from the FDA in April 2026. Aragen originally created the cell line and early process at its Morgan Hill, California site, with GMP production now transitioned to the company’s new commercial biologics facility in Bengaluru, India.
The Bengaluru site is being equipped with multiple 2KL bioreactors to support both scale-up and scale-out, enabling the same molecule to be manufactured across bioreactors for faster readiness for clinical and commercial supply. The suite can produce 60-70 batches annually at 2 KL scale, with a turnaround of one batch every 4-5 days at full capacity. It can also operate in scale-out mode with two 2 KL bioreactors in parallel to deliver a 4KL batch size, supporting both fed-batch and intensified fed-batch production.
Renaissance has previously reported strong phase 2 results for Daretabart, with 73.7% event-free survival and 86% overall survival at three years in children with high-risk neuroblastoma.
The transfer to Aragen’s $40 million Bengaluru facility included a several-fold increase in titer and right-first-time execution from bench to 2KL GMP scale. Simon Ball, Director of Renaissance Pharma, said: “Our partnership with Aragen exemplifies the power of integrated CDMO expertise. The Morgan Hill-to-Bengaluru handoff delivered exceptional results that enabled us to meet key clinical development milestones within 9 months.”
This marks the sixth programme to advance from early-phase development in Morgan Hill to clinical supply in Bengaluru, reflecting a discovery-to-manufacturing model designed to accelerate biotech programmes toward BLA submission.
Subodh Deshmukh, CEO of Biologics at Aragen, said: “Aragen’s dual-hub model – R&D innovation in California and GMP scale in India – enables seamless gene-to-GMP pathways with industry-leading COGS and quality. We’re proud to support Renaissance in scaling Daretabart efficiently and reliably to support their BLA and launch.”
