Aragen to manufacture Renaissance Pharma’s FDA Fast Track antibody candidate
Aragen, a contract research, development, and manufacturing organization (CRDMO) headquartered in Hyderabad, India, completed technology transfer and commercial-scale GMP manufacturing of Renaissance Pharma’s lead monoclonal antibody candidate Daretabart for high-risk neuroblastoma as part of an ongoing strategic collaboration.
Daretabart, a humanized 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 the announcement, Aragen developed the cell line and initial manufacturing process at its Morgan Hill, California site before transferring GMP production to its commercial biologics facility in Bengaluru, India. The company said the transfer and first commercial-scale GMP batches were completed within nine months.
The Bengaluru facility features multiple 2,000-liter bioreactors designed to support both scale-up and scale-out manufacturing strategies. The manufacturing suite can produce 60 to 70 batches annually at the 2,000-liter scale and can operate two bioreactors in parallel to achieve 4,000-liter batch sizes. The facility supports both fed-batch and intensified fed-batch production processes.
According to the company, process performance improved during technology transfer to the newly built $40 million Bengaluru facility, with production titers increasing several-fold while maintaining right-first-time execution through GMP scale-up.
“This latest tech transfer marks the sixth program to progress from early-phase development in Morgan Hill to clinical supply in Bengaluru, demonstrating a discovery-manufacturing model designed to accelerate biotech programs toward BLA submission,” the company said.
“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,” Subodh Deshmukh, CEO of Biologics at Aragen, said in a statement. “We’re proud to support Renaissance in scaling Daretabart efficiently and reliably to support their BLA and launch.”
Earlier this year, Aragen launched a CHO-based biologics development platform designed to move standard IgG monoclonal antibody programs from DNA to IND-enabling clinical supply in approximately 10 months. The platform integrates cell line development, process development, analytical workflows, and GMP manufacturing under a royalty-free model intended to streamline early biologics development and regulatory readiness.