Aragen begins commercial GMP production of FDA Fast Track monoclonal antibody in major biologics scale-up shift
Aragen has started commercial GMP manufacturing of Daretabart, a humanised anti-GD2 monoclonal antibody developed by Renaissance Pharma for high-risk neuroblastoma. The company carried out early development and cell line work in Morgan Hill, California. However, it now produces the molecule at its new biologics facility in Bengaluru, India.
Renaissance Pharma received FDA Fast Track Designation for Daretabart in April 2026. The programme continues to progress toward BLA submission while manufacturing capacity expands to support clinical and commercial supply needs.
Bengaluru facility supports 2,000L bioreactor GMP manufacturing for high-capacity biologics production
Aragen operates multiple 2,000L bioreactors at its Bengaluru site to support both scale-up and scale-out production strategies. The facility delivers up to 60–70 GMP batches per year at full capacity. It also supports a batch turnaround of one production cycle every 4–5 days during peak operations.
The manufacturing setup enables parallel bioreactor operation, allowing up to 4KL batch size. In addition, the system supports both fed-batch and intensified fed-batch processes for commercial biologics production.
9-month tech transfer enables rapid biologics scale-up across US–India manufacturing hubs
The technology transfer from Morgan Hill to Bengaluru took nine months to complete. Aragen reported increased process titer during the transition and achieved right-first-time execution from development scale to 2KL GMP production, ensuring smooth scale-up without major process deviations.
This marks the sixth programme transferred from early development in Morgan Hill to GMP manufacturing in Bengaluru. The model connects early-stage development with commercial biologics production across two geographic hubs.
Clinical data supports continued development of Daretabart in high-risk neuroblastoma
Renaissance Pharma reported Phase 2 results for Daretabart in high-risk neuroblastoma, showing 73.7% event-free survival and 86% overall survival at three years. The programme continues under FDA Fast Track designation as it advances toward later-stage development and regulatory submission.
Aragen expands dual-hub biologics manufacturing model to accelerate global GMP supply chains
Aragen operates a dual-hub model combining R&D and process development in Morgan Hill, California with GMP manufacturing in Bengaluru, India. The company uses this structure to support scale-up, reduce manufacturing timelines, and maintain continuity between development and commercial production.
The Bengaluru facility represents part of Aragen’s $40 million biologics manufacturing expansion designed to increase GMP capacity for global biologics programmes.
This kind of rapid GMP tech transfer highlights how critical structured Qualification and Validation for GMP-Regulated Systems is in ensuring process consistency and regulatory readiness at commercial scale. Learn how Zaman Pharma supports pharmaceutical teams in building compliant, inspection-ready systems through end-to-end qualification and validation support across the full system lifecycle.
Source: Pharmatimes.Com