Aragen, a global Contract Research, Development, and Manufacturing Organization (CRDMO), successfully completed the technology transfer and manufactured the first commercial-scale Good Manufacturing Practice (GMP) batches of Renaissance Pharma’s lead biologic candidate, Daretabart, within just nine months.
Daretabart is a humanized anti-GD2 monoclonal antibody (mAb) being developed for the treatment of high-risk neuroblastoma (HRNB), a rare and aggressive pediatric cancer. The achievement marks a significant milestone in the ongoing strategic collaboration between Aragen and Renaissance Pharma and demonstrates the effectiveness of Aragen’s integrated biologics development and manufacturing platform.
FDA Fast Track Designation Strengthens Program Momentum
In April 2026, Daretabart received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of high-risk neuroblastoma. The designation highlights the urgent need for innovative therapies for this life-threatening childhood cancer and is expected to accelerate the development and review process.
Aragen initially developed the cell line and early-stage manufacturing process for Daretabart at its Morgan Hill facility in California. Subsequently, the program was successfully transferred to Aragen’s commercial biologics manufacturing facility in Bengaluru, India, where GMP production is now being carried out at commercial scale.
Bengaluru Facility Designed for Flexible Commercial Production
Aragen’s Bengaluru biologics facility has been designed to support both scale-up and scale-out manufacturing strategies. The site plans to operate multiple 2,000-liter (2 KL) bioreactors, enabling the production of the same biologic molecule across several reactors simultaneously.
This flexible manufacturing approach allows faster readiness for clinical and commercial supply requirements while maintaining operational efficiency. At full capacity, the facility can manufacture approximately 60–70 batches annually at the 2 KL scale, with a turnaround time of one batch every four to five days.
In addition, the facility can operate two 2 KL bioreactors in parallel, effectively delivering a 4 KL batch size. The manufacturing suite supports both fed-batch and intensified fed-batch production processes, providing greater flexibility for diverse biologics programs.
Accelerated Technology Transfer Delivers Strong Results
The successful transfer of Daretabart production to Aragen’s newly commissioned $40 million commercial biologics facility in Bengaluru represents a major advancement in the program’s clinical and commercial readiness. During the technology transfer process, Aragen achieved several-fold improvements in product titer while maintaining right-first-time execution from laboratory scale through to 2 KL GMP manufacturing. The seamless transition underscores the company’s expertise in scaling biologics programs from development to commercial production.
Promising Clinical Outcomes for Daretabart
Daretabart has already demonstrated encouraging clinical efficacy in Phase II studies. Renaissance Pharma reported a three-year event-free survival rate of 73.7% and an overall survival rate of 86% among pediatric patients with high-risk neuroblastoma. These positive clinical outcomes reinforce the potential of Daretabart to address a critical unmet medical need in pediatric oncology and support the program’s advancement toward regulatory submission and commercialization.
Leadership Highlights Value of Integrated Development Model
Simon Ball, Director of 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 nine months.”
The latest technology transfer also marks the sixth program to successfully progress from
early-phase development at Aragen’s Morgan Hill site to clinical supply manufacturing in Bengaluru. This track record highlights the strength of Aragen’s discovery-to-manufacturing model, which is designed to accelerate biotech programs toward Biologics License Application (BLA) submission.
Subodh Deshmukh, CEO – Biologics at Aragen, added, “Aragen’s dual-hub model—combining R&D innovation in California with GMP manufacturing scale in India—enables seamless gene-to-GMP pathways with industry-leading cost efficiencies and quality standards. We are proud to support Renaissance Pharma in scaling Daretabart efficiently and reliably as it advances toward BLA submission and commercial launch.”
Strengthening Biologics Manufacturing Capabilities
The successful commercialization of Daretabart manufacturing further strengthens Aragen’s position as a global biologics CRDMO. As per the press release, by integrating early-stage development, process optimization, technology transfer, and commercial-scale GMP manufacturing within a unified platform, the company continues to help biotechnology innovators accelerate the journey from discovery to market.
