Bringing an FDA Fast Track monoclonal antibody from technology transfer to Phase 2b/3 cGMP supply in nine months is not a target most biologics teams would put in their project plan. It is, however, exactly what Aragen achieved for Renaissance Pharma's lead candidate, Daretabart — a humanized monoclonal antibody targeting GD2 for high-risk neuroblastoma through integrated strategy that aligns process development, quality systems, technology transfer, validation, digital tools, and commercial operations from the outset.
This webinar presents a detailed, data-backed account of how that outcome was made possible — and what it means for bio-techs and pharma companies with complex biologics programmes that cannot afford manufacturing delays. At the heart of this outcome is Aragen’s dual-hub biologics model: “R&D innovation in California and GMP scale in India — enabling seamless gene-to-GMP pathways with industry-leading COGS and quality.
Attendees will hear directly from the Aragen biologics team on the specific decisions, process design choices, and manufacturing strategies that enabled this timeline. The session will cover he Bengaluru facility’s intensified fed batch production capability and its flexibility to house multiple single-use 2KL bioreactors, delivering one batch every four to five days at full capacity. It will also address the regulatory and CMC documentation approach required to support an FDA Fast Track program moving toward BLA submission.
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