Aragen, a global leader in Contract Research, Development, and Manufacturing Organization (CRDMO) services, has announced the successful technology transfer and commercial-scale GMP manufacturing of the first batches of Daretabart, Renaissance Pharma’s lead therapeutic candidate for high-risk neuroblastoma. The milestone was achieved within just nine months, highlighting the efficiency of the collaboration between the two organizations.
Daretabart, a humanized monoclonal antibody designed to target GD2, received Fast Track Designation from the FDA in April 2026 for the treatment of high-risk neuroblastoma (HRNB), a rare form of pediatric cancer. The achievement marks another important step in the ongoing strategic partnership between Aragen and Renaissance Pharma. Earlier in the program, Aragen developed the cell line and initial manufacturing process at its Morgan Hill, California facility before transitioning GMP production to its commercial biologics site in Bengaluru, India.
Aragen’s Bengaluru facility is equipped with multiple 2KL bioreactors that support both scale-up and scale-out manufacturing approaches. This setup enables the same molecule to be produced across multiple bioreactors, helping accelerate readiness for clinical and commercial supply requirements. At full capacity, the facility can manufacture approximately 60–70 batches annually at the 2KL scale, with production cycles completed every four to five days. The site also offers parallel operation of two 2KL bioreactors, creating a 4KL batch size while supporting both fed-batch and intensified fed-batch production processes.
Renaissance Pharma has previously reported encouraging Phase II clinical outcomes for Daretabart, including 73.7% event-free survival and 86% overall survival after three years among pediatric patients with high-risk neuroblastoma.
The transfer of manufacturing activities to Aragen’s newly established $40 million commercial biologics facility in Bengaluru represents a significant advancement in clinical production capabilities. During the technology transfer process, which incorporated up to 2KL single-use bioreactors, production titers increased several-fold while maintaining right-first-time execution from laboratory scale through 2KL GMP manufacturing.
“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,” he added.
The latest achievement represents the sixth program to successfully transition from early-stage development in Morgan Hill to clinical supply manufacturing in Bengaluru. This integrated discovery-to-manufacturing framework is designed to accelerate biotechnology programs on their path toward BLA submission.
Commenting on the milestone, Subodh Deshmukh, CEO of Biologics at Aragen, said, “We’re proud to support Renaissance in scaling Daretabart efficiently and reliably to support their BLA and launch.”
