Aragen Life Sciences begins operations at OneHP, an integrated high-potency platform in Hyderabad, India. Oct 08, 2026, 07:30 ET NEW YORK, Oct. 8, 2026 /PRNewswire/ - Aragen Life Sciences, among the top three largest Indian CRDMOs, begins operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad. The platform adds capabilities for highly potent molecules, including cytotoxic payloads used in oncology, providing customers with an integrated pathway from milligram-scale discovery through process development and multi-kilogram cGMP manufacturing. Aragen OneHP spans approximately 15,000 sq ft and operates one manufacturing line with a designed capacity of 500-600 kg of active pharmaceutical ingredient a year. The platform supports highly potent compounds, including cytotoxic molecules and targeted Oncology therapies, and lays the foundation for expansion into advanced modalities. OneHP offers an integrated pathway from development through clinical and commercial supply worldwide, with manufacturing spanning small-scale chemistry synthesis (upto 10g), non-GMP process development and scale-up (upto 500g), and cGMP manufacturing (500g to 5kg per batch). Advanced containment systems are designed to handle compounds at occupational exposure limits of upto 10 ng/m[3], subject to ongoing validation. Aragen serves a global customer base, with nearly 95% of revenue from global customers in the year ending March 2026. The company served 591 customers globally in that year, including 16 of the world's Top 20 Big pharmaceutical companies. Aragen operates six facilities across India and the United States, including five in India and one in Morgan Hill, California. Aragen's US presence includes a biologics R&D facility in Morgan Hill, California. With OneHP adding specialised high-potency development and cGMP manufacturing capabilities in Hyderabad, Aragen is further strengthening its India-based execution platform for global customers. Mr. Aniel Khubchandani, Chief Executive Officer - Small Molecules-CDMO, Aragen Life Sciences: "With OneHP, we are bringing discovery, development and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and programme context connected as a molecule moves from early development towards commercial supply." Highly potent molecules like cytotoxic compounds require specialised handling, containment and manufacturing infrastructure. OneHP combines capabilities across small-scale chemistry synthesis, process development, scale-up and cGMP manufacturing, enabling customers to progress programmes through an integrated platform. The platform lays foundation for Aragen's future expansion into advanced modalities like antibody-drug conjugates and peptide-drug conjugates. Aragen's Hyderabad manufacturing and analytical operations are accredited by USFDA, EDQM, PMDA, MFDS, ANVISA, WHO Geneva and CDSCO. SOURCE Aragen Life Sciences

Aragen launches high-potency CRDMO platform in Hyderabad for oncology molecules. Hyderabad: Aragen Life Sciences has commenced operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad, adding capabilities for highly potent molecules, including cytotoxic compounds used in oncology. The approximately 15,000 sq ft platform is designed to provide customers with an integrated pathway from milligram-scale discovery through process development, scale-up and multi-kilogram current Good Manufacturing Practice (cGMP) manufacturing. Aragen OneHP operates one manufacturing line with a designed capacity of 500 to 600 kg of active pharmaceutical ingredient (API) annually. The platform can support highly potent compounds, including cytotoxic molecules and targeted oncology therapies, and is also intended to provide a foundation for future expansion into advanced modalities. The platform includes small-scale chemistry synthesis of up to 10 g, non-GMP process development and scale-up of up to 500 g, and cGMP manufacturing from 500 g to 5 kg per batch. Advanced containment systems at the facility are designed to handle compounds with occupational exposure limits of up to 10 ng/m[3], subject to ongoing validation. According to Aragen, OneHP will enable programmes to progress from development through clinical and commercial supply through an integrated platform, reducing the need for handoffs between different service providers. "With OneHP, we are bringing discovery, development and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and programme context connected as a molecule moves from early development towards commercial supply," said Aniel Khubchandani, Chief Executive Officer - Small Molecules-CDMO, Aragen Life Sciences. Highly potent molecules, including cytotoxic compounds, require specialised handling, containment and manufacturing infrastructure. The new platform brings together small-scale chemistry synthesis, process development, scale-up and cGMP manufacturing capabilities for such molecules. Aragen said OneHP also lays the foundation for future expansion into advanced modalities such as antibody-drug conjugates (ADCs) and peptide-drug conjugates. The new platform is part of Aragen's ongoing capacity expansion programme. The company invested more than Rs 1,000 crore in capital expenditure over the three years ended March 2026 to build capabilities across small molecules and biologics. Aragen's contract development and manufacturing business grew at a compound annual growth rate of 19% during the period, while its contract research business grew at 12%. As of March 31, 2026, the company's installed small-molecule capacity stood at 364 KL across its Hyderabad and Visakhapatnam facilities. Nearly 95% of Aragen's revenue in the year ended March 2026 came from global customers, while the company served 591 customers globally, including 16 of the world's Top 20 pharmaceutical companies. Aragen's Hyderabad manufacturing and analytical operations are accredited by the USFDA, EDQM, PMDA, MFDS, ANVISA, WHO Geneva and CDSCO. Aragen Life Sciences is a contract research, development and manufacturing organization serving global pharmaceutical, biotechnology, animal health and agrochemical companies. Its capabilities span drug discovery, pre-clinical research, development and manufacturing for small molecules and biologics. Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at [email protected]. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here. NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at [email protected] for evaluation. Sheeba Farhat Joined Medical Dialogues in 2018 to report on the latest Education news. A Graduate of the University of Delhi, she specializes in covering stories related to Medical Education updates. For inquiries or further information, you can reach her at [email protected]. Our comments section is governed by our Comments Policy. By posting comments at Medical Dialogues you automatically agree with our Comments Policy, Terms And Conditions and Privacy Policy.

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."