Aragen to Manufacture Renaissance Pharma’s Fast Track mAb  

Aragen, a global Contract Research, Development, and Manufacturing Organization (CRDMO), has successfully tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart – a humanized monoclonal antibody targeting GD2 for high-risk neuroblastoma.

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 pediatric cancer. Under a strategic partnership between the two companies, Aragen 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 2KL 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 three years in pediatric patients with high-risk neuroblastoma.

The successful transfer to Aragen’s newly built $40 million commercial facility in Bengaluru marks an acceleration in clinical production. During the technology transfer to the new site, which features up to 2KL single-use bioreactor, the titer was increased several folds, with right-first-time execution from bench to 2KL 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.”