- Aragen has completed the technology transfer and manufacture of the first commercial-scale GMP batches of Renaissance Pharma’s anti-GD2 monoclonal antibody, Daretabart, within nine months.
- The program transitioned from process development in California to commercial-scale biologics manufacturing in Bengaluru, India, supporting preparations for future BLA submission and commercialization.
Aragen has successfully completed the technology transfer and manufacture of the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart, a humanized monoclonal antibody targeting GD2 for the treatment of high-risk neuroblastoma. The CRDMO said the transfer and manufacturing activities were completed within nine months as part of an ongoing partnership between the two companies.
The program originated at Aragen’s Morgan Hill, California site, where the company developed the cell line and initial manufacturing process. GMP production has now been transferred to Aragen’s commercial biologics facility in Bengaluru, India, where Daretabart is being manufactured at commercial scale. The anti-GD2 monoclonal antibody received FDA Fast Track Designation in April 2026 for the treatment of high-risk neuroblastoma, a rare pediatric cancer.
According to Aragen, the Bengaluru facility is equipped with multiple 2,000-liter bioreactors that support both scale-up and scale-out manufacturing strategies. The company stated that the suite can produce 60 to 70 batches annually at the 2 KL scale and can also operate two bioreactors in parallel to achieve a 4 KL batch size. The facility supports both fed-batch and intensified fed-batch production processes.
“Our partnership with Aragen exemplifies the power of integrated CDMO expertise. The Morgan Hill-to-Bengaluru handoff delivered exceptional results that enabled us to meet key clinical development milestones within 9 months.”
Simon Ball, Director of Renaissance Pharma
Aragen said the transfer to its $40 million commercial biologics facility marks the sixth program to progress from early-phase development in Morgan Hill to clinical supply in Bengaluru. The company stated that its dual-site model is designed to support biotech companies from development through GMP manufacturing and toward biologics license application (BLA) submission.
