By: IPP Bureau
Last updated : June 03, 2026 10:31 am
Anti-GD2 monoclonal antibody for high-risk neuroblastoma advances toward BLA submission following successful tech transfer from California to Bengaluru
Aragen, a global CRDMO, has delivered a major milestone in biomanufacturing—completing tech transfer and producing the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart, in just nine months.
Daretabart, a humanized monoclonal antibody targeting GD2, is being developed for high-risk neuroblastoma, a rare and aggressive pediatric cancer. The program has already gained momentum with the U.S. FDA granting Fast Track Designation in April 2026 for high-risk neuroblastoma treatment.
The achievement builds on a deepening partnership between the two companies. Aragen had previously developed the cell line and early process at its Morgan Hill, California site before shifting GMP manufacturing to its commercial biologics facility in Bengaluru, India.
Aragen operates this global CRDMO network spanning R&D and manufacturing hubs across the U.S., Europe, and India.
At the Bengaluru facility, Aragen has deployed a flexible biomanufacturing setup featuring multiple 2KL single-use bioreactors designed for both scale-up and scale-out. The system supports rapid switching between configurations, enabling faster readiness for clinical and commercial supply.
The site is engineered for high-throughput production, capable of 60–70 batches annually at 2KL scale, with a turnaround time of one batch every 4–5 days at full capacity. In parallel mode, two 2KL bioreactors can run simultaneously to deliver a 4KL batch. The facility supports both fed-batch and intensified fed-batch production strategies.
Renaissance Pharma has previously reported strong Phase II outcomes for Daretabart, including 73.7% event-free survival and 86% overall survival at three years in pediatric patients with high-risk neuroblastoma.
The tech transfer to Aragen’s newly built $40 million Bengaluru facility also delivered process gains. Titer levels increased several-fold during the transition to the 2KL GMP scale, with “right-first-time” execution from bench to production.
“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.”
This marks the sixth program successfully moved from early development in Morgan Hill to clinical supply in Bengaluru, reinforcing a model designed to accelerate biologics development toward BLA submission.
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.”