Aragen manufactures first GMP batches of Daretabart

Aragen, a Contract Research, Development, and Manufacturing Organisation (CRDMO), has announced the successful technology transfer and manufacturing of the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart, in nine months.

Daretabart is a humanised monoclonal antibody targeting GD2 for the treatment of high-risk neuroblastoma (HRNB), a paediatric cancer. In April 2026, the anti-GD2 monoclonal antibody received Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of HRNB.

The milestone forms part of a partnership between Aragen and Renaissance Pharma. Aragen had previously developed the cell line and initial process for the programme at its Morgan Hill facility in California. GMP manufacturing has now been transferred to Aragen’s biologics manufacturing facility in Bengaluru, India, at commercial scale.

Aragen stated that its Bengaluru facility plans to have multiple 2KL bioreactors to support both scale-up and scale-out manufacturing. The company said this approach enables the same molecule to run across bioreactors, supporting readiness for clinical and commercial supply requirements.

According to the company, the manufacturing suite can produce 60–70 batches annually at 2KL scale, with a turnaround time of one batch every four to five days at full capacity. The facility can also operate in a scale-out mode, with two 2KL bioreactors running in parallel to provide a batch size of 4KL. The site supports both fed-batch and intensified fed-batch production.

Renaissance Pharma previously reported Phase II results for Daretabart, achieving 73.7 per cent event-free survival and 86 per cent overall survival at three years in paediatric patients with high-risk neuroblastoma.

Aragen said the transfer to its Bengaluru facility, built with an investment of $40 million, marks a step in clinical production. During the technology transfer process, which involved a manufacturing setup featuring up to 2KL single-use bioreactors, the titre increased several folds, with right-first-time execution from bench scale to 2KL GMP scale.

Commenting on the development, Simon Ball, Director, Renaissance Pharma, said, “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.”

The company stated that this is the sixth programme to progress from early-phase development at Morgan Hill to clinical supply in Bengaluru. Aragen said the model is designed to support biotechnology programmes progressing towards Biologics License Application (BLA) submission.

Subodh Deshmukh, CEO – Biologics, Aragen, 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. We’re proud to support Renaissance in scaling Daretabart efficiently and reliably to support their BLA and launch.”