Aragen, a leading global contract research, development and manufacturing organisation (CRDMO), has successfully tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart — a humanised monoclonal antibody targeting GD2 for high-risk neuroblastoma — in just 9 months.
The anti-GD2 monoclonal antibody received Fast Track Designation from the FDA in April 2026 for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer.
This milestone builds on a broader strategic partnership between the two companies, with Aragen having developed the cell line and initial process at its Morgan Hill site in California.
GMP manufacturing for the program has now transitioned to Aragen’s commercial biologics facility in Bengaluru, India at the commercial scale.
The Aragen Bengaluru site plans to have multiple 2 kL bioreactors enabling both scale-up and scale-out.
This manufacturing strategy will allow the same molecule to be run across bioreactors, supporting faster readiness towards clinical and commercial supplies.
The manufacturing suite is capable of producing 60-70 batches annually at 2 kL scale with a turnaround of one batch every 4–5 days at full capacity.
Additionally, the suite can be operated in a scale-out mode with two 2 KL bioreactors running in parallel to provide a batch size of 4KL. This facility supports both fed-batch and intensified fed-batch production.
Renaissance Pharma has previously demonstrated strong Phase II results with Daretabart, achieving 73.7% event-free survival and 86% overall survival at 3 years in pediatric patients with high-risk neuroblastoma.
The successful transfer to Aragen’s newly built $40m commercial facility in Bengaluru marks an acceleration in clinical production.
During the technology transfer to the new site, which features up to 2 kL single-use bioreactor, the titer was increased by several fold, with right-first-time execution from bench to 2 kL GMP scale.
“Our partnership with Aragen exemplifies the power of integrated CDMO expertise,” said Simon Ball, Director of Renaissance Pharma.
“The Morgan Hill-to-Bengaluru handoff delivered exceptional results that enabled us to meet key clinical development milestones within 9 months.”
Subodh Deshmukh, CEO of Biologics at Aragen, added: “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.”