Aragen manufactures first GMP batches of Daretabart. Technology transfer moves anti-GD2 monoclonal antibody programme from California to Bengaluru following FDA Fast Track Designation for high-risk neuroblastoma. 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."

Aragen launches 'ChemiSHE', India's first women-led chemistry synthesis laboratory. CRDMO announces strategic diversity initiative to add 800 - 1,000 women employees across scientific and leadership roles over the next three years 13 April 2026 - Hyderabad, India: Aragen, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) launched ChemiSHE, a first-of-its-kind chemistry synthesis laboratory in India, entirely operated and led by women scientists. The lab was inaugurated on 8 April 2026 at Aragen's Mallapur campus in Hyderabad. ChemiSHE is part of a broader strategic initiative to strengthen gender diversity across Aragen's scientific workforce and create structured leadership pathways for women in pharmaceutical R&D. The lab will launch with an initial team of 12-14 scientists and is designed to provide greater ownership of research programmes, increase visibility of scientific contributions, and accelerate progression into decision-making roles. Ms. Aparna Reddy, Entrepreneur, Philanthropist, and Former National President of FICCI FLO, who inaugurated the lab as chief guest, commented "ChemiSHE is a strong expression of the role women scientists play at Aragen and an important initiative to support the growth of women leaders. It creates an environment where women can work together, learn from one another, and grow under the mentorship of a woman leader." Speaking at the inauguration, Manni Kantipudi, Managing Director & CEO of Aragen, commented "ChemiSHE is designed in line with the International Women's Day 2026 theme of 'Give to Gain' - and it reflects our conviction that investing in women's leadership multiplies innovation and scientific excellence. Over the next three years, we plan to add 800-1,000 women employees across scientific, operational, and leadership functions as we build a more balanced and future-ready workforce." The lab will be led by Pragya Yadav, Scientific Manager, Discovery Chemistry Solutions, Aragen. Aragen's commitment to diversity complements its position as one of the world's leading CRDMOs, powered by Digital & AI, serving over 450 global pharma and biotech customers across the drug discovery, development, and manufacturing continuum. Notes to editors About Aragen: Aragen Life Sciences is a globally renowned R&D and manufacturing solutions provider to the global life sciences industries. It offers a range of solutions across the drug discovery, development and manufacturing continuum to advance small and large-molecule programs. The Company operates through a global network of eight sites with a team of 5000+ employees including 450+ PhDs. Its expertise and experience have enabled over 450 customers to advance their research programs from early discovery through development and commercialization. Aragen's innovative mindset, infrastructure, flexible business models, clear purpose, and proprietary project management platform have enabled it to effectively scale and service large pharma, biotech, agrochemical, and animal health industries globally. Visit www.aragen.com for more details. Media Contacts: Aragen: Hyderabad, India: Prasad Babu, [email protected]; +91 91546 68768