Nucelion Therapeutics, a contract research, development and manufacturing organisation (CRDMO) specialising in cell and gene therapies, has partnered with VeGen Bio to advance the development and manufacturing of innovative cell therapies in India. The agreement covers technology transfer, clinical-stage manufacturing and commercialisation. Under the partnership, Nucelion Therapeutics, a wholly owned subsidiary of Bharat Biotech, will support VeGen Bio’s lead candidate, VL-2511, a first-in-class dual BCMA/CD19 autologous CAR-T cell therapy for multiple myeloma. Nucelion will undertake technology transfer and clinical- and commercial-stage manufacturing at its single-site Good Manufacturing Practice (GMP) facility. The facility is designed to meet regulatory standards set by the Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Partnership Aims to Improve CAR-T Manufacturing Efficiency
The companies will focus on process optimisation, manufacturing yields and operational efficiency to improve production economics. Consequently, these efforts aim to reduce manufacturing costs and expand access to advanced cell therapies for patients in India. The partnership will also strengthen domestic manufacturing capabilities for innovative cancer treatments while creating opportunities to support the future expansion of VeGen Bio’s cell therapy pipeline.
Nucelion Targets Global Manufacturing Standards
Raghu Malapaka, PhD, Chief Business Officer (CBO) of Nucelion Therapeutics, said the collaboration demonstrates the company’s approach to expanding cell therapy manufacturing capabilities in India. He added that the company’s facility is designed to meet US FDA and EMA standards, enabling companies to pursue commercial launches in global markets, subject to the applicable regulatory approvals.
VeGen Bio Sees Opportunities for Pipeline Expansion
Prashant Bhavar, Director of VeGen Bio, said the partnership combines the complementary strengths of both organisations. He noted that the agreement provides VeGen Bio with a pathway for technology transfer, manufacturing and pipeline expansion, while helping Nucelion strengthen its cell therapy manufacturing capabilities. As reported by thehindubusinessline.com, through the collaboration, both companies aim to advance the manufacturing readiness of VL-2511 and support the broader development of cell and gene therapies in India.