By: IPP Bureau
Last updated : June 02, 2026 5:07 pm
Anti-GD2 monoclonal antibody for high-risk neuroblastoma advances toward BLA submission following successful tech transfer from California to Bengaluru
Aragen, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has successfully completed the technology transfer and commercial-scale GMP manufacturing of the first batches of Renaissance Pharma’s lead candidate, Daretabart, within nine months.
Daretabart, a humanized anti-GD2 monoclonal antibody being developed for the treatment of high-risk neuroblastoma (HRNB), received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in April 2026.
The rare pediatric cancer therapy is now being manufactured at commercial scale at Aragen’s biologics facility in Bengaluru, India, following development of the cell line and initial process at the company’s Morgan Hill, California site.
The Bengaluru facility, established with an investment of $40 million, is designed to support large-scale biologics production through multiple 2KL single-use bioreactors.
The manufacturing suite is capable of producing 60–70 batches annually at the 2KL scale, with a turnaround time of four to five days per batch at full capacity. It also supports scale-out operations through parallel bioreactor runs, enabling batch sizes of up to 4KL and accommodating both fed-batch and intensified fed-batch production processes.
The successful transfer from Morgan Hill to Bengaluru resulted in several-fold increases in production titer and achieved right-first-time execution from bench-scale development to 2KL GMP manufacturing.
Renaissance Pharma has previously reported encouraging Phase II clinical results for Daretabart, with event-free survival of 73.7 percent and overall survival of 86 percent at three years among pediatric patients with high-risk neuroblastoma.
“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.”
The Daretabart program represents the sixth project to transition from early-stage development at Aragen’s Morgan Hill facility to clinical supply manufacturing in Bengaluru, highlighting the company’s integrated discovery-to-manufacturing platform.
“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,” said Subodh Deshmukh, CEO of Biologics at Aragen. “We’re proud to support Renaissance in scaling Daretabart efficiently and reliably to support their BLA and launch.”