Aragen manufactures first GMP batches of Daretabart

Aragen and Renaissance manufacture rare disease therapy

Aragen manufactures first commercial GMP batches of Daretabart for Renaissance Pharma, a mAb targeting high-risk neuroblastoma with FDA Fast Track status.

Aragen to manufacture Renaissance Pharma’s FDA Fast Track mAb

Aragen scales Daretabart to commercial-ready production following rapid 9‑month tech transfer

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…