Bharat Biotech Launches Nucelion Therapeutics for Cell and Gene Therapy Manufacturing

Bharat Biotech International Ltd has announced the establishment of “Nucelion Therapeutics”, a wholly owned subsidiary positioned as a Contract Research, Development and Manufacturing Organisation (CRDMO) specialising in advanced cell and gene therapies. The new venture, based in Hyderabad’s Genome Valley, aims to provide end-to-end solutions for global life science innovators focused on cutting-edge biological treatments.

Focus on Advanced Therapy Platforms

Nucelion Therapeutics is designed to serve as a comprehensive partner for the development and large-scale manufacturing of complex therapies. Its focus areas include cancers, autoimmune diseases, and rare genetic disorders. According to Non-Executive Director Krishna Ella, the initiative represents Bharat Biotech’s strategic expansion into the next generation of biomedical innovation. “The future of pharmaceutical innovation will be biological. Our vision is to integrate advanced therapy platforms into India’s healthcare ecosystem, ensuring equitable access to life-changing treatments,” Ella stated.

Global-Standard Infrastructure and Services

The company has commissioned a state-of-the-art GMP (Good Manufacturing Practice) facility capable of developing plasmids, viral and non-viral vectors, autologous and allogeneic cell therapies, along with aseptic fill and finish services. These capabilities will enable Nucelion to support projects from pre-clinical research to commercial-scale manufacturing, adhering to global regulatory standards set by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Independent Operations and Global Partnerships

Chief Business Officer Raghu Malapaka highlighted that Nucelion will operate independently with its own leadership, governance, and information systems. While it will collaborate with Bharat Biotech, all engagements will occur on arm’s-length commercial terms. The company plans to attract top global talent with expertise in the design and execution of cell and gene therapy programmes, strengthening India’s position as a global hub for biomanufacturing excellence.

Exam Oriented Facts

• Bharat Biotech launched Nucelion Therapeutics, a CRDMO for cell and gene therapies, in November 2025.
• The facility is located in Genome Valley, Hyderabad, and meets GMP, FDA, and EMA standards.
• Nucelion focuses on plasmids, viral/non-viral vectors, and cell therapy manufacturing.
• Krishna Ella serves as Non-Executive Director; Raghu Malapaka is Chief Business Officer.

Strengthening India’s Biotech Ecosystem

The launch of Nucelion Therapeutics marks a major milestone in India’s biotechnology landscape, aligning with the country’s vision to become a global leader in biopharmaceutical innovation. By offering integrated research and manufacturing services, the company aims to accelerate the availability of advanced therapies and expand access to cutting-edge treatments for patients worldwide.