Bharat Biotech Launches Nucelion CRDMO to Advance Cell and Gene Therapy Manufacturing in India
核心洞察
Bharat Biotech International has launched Nucelion Therapeutics (搜索), a wholly owned CRDMO subsidiary dedicated to cell and gene therapy development and manufacturing from a 30,000 sq ft GMP facility in Genome Valley.
The new entity offers comprehensive advanced therapy manufacturing capabilities including plasmid DNA, viral vectors, and autologous/allogeneic cell therapies, with compliance to US FDA and European Medicines Agency regulatory frameworks.
Nucelion aims to position India as a contributor to breakthrough therapies rather than merely a consumer, targeting the fast-growing global CGT market that is expanding at double-digit CAGR rates.
Indian vaccine giant Bharat Biotech International has announced the launch of Nucelion Therapeutics (搜索), a wholly owned Contract Research Development and Manufacturing Organisation (CRDMO) dedicated to cell and gene therapy (CGT) development and production. The newly established subsidiary represents a significant strategic expansion into one of the fastest-growing segments of the pharmaceutical industry.
Advanced Manufacturing Capabilities
Nucelion begins operations from a purpose-built 30,000 sq ft GMP facility located in Genome Valley, India's largest lifesciences cluster. The facility has been commissioned to develop and manufacture plasmids, viral and non-viral vectors, and cell therapies for rare diseases, cancer and autoimmune disorders.
The company will offer a comprehensive suite of advanced therapy manufacturing capabilities, including the development of plasmid DNA, viral and non-viral vectors, autologous and allogeneic cell therapies, and aseptic fill & finish services. These capabilities support clients from early clinical phases through to global commercial supply.
Dr. Raghu Malapaka, Chief Business Officer of Nucelion, emphasized the company's comprehensive approach: "At Nucelion, we will provide end-to-end solutions from clinical to commercial scale, ensuring compliance with global standards (FDA, EMA). Our services include the development and manufacturing of plasmid DNA, viral vectors, autologous, and allogeneic cell therapies."
Regulatory Compliance and Market Access
The facility is aligned with US FDA and European Medicines Agency (EMA) regulatory frameworks, enabling Nucelion to serve both domestic and international markets. The company will operate with independent governance, leadership and information systems, maintaining arm's-length commercial relationships with all clients, including its parent company Bharat Biotech.
Addressing Market Growth and Industry Needs
Industry trackers estimate that the global CGT market is growing at double-digit CAGR, fueled by manufacturing and analytical advancements that are enabling treatments once confined to rare, ultra-expensive therapies to move into broader therapeutic areas. The momentum is most pronounced in oncology, immunology and regenerative care, where scalable platforms are emerging to support mass-market access.
Dr. Krishna Ella, Executive Chairman of Bharat Biotech and Non-Executive Director of Nucelion, highlighted the strategic vision: "The future of pharmaceutical innovation will be biological; CGTs are a key vector and our vision is to integrate advanced therapy platforms into solutions for complex and rare diseases."
Strategic Positioning for India
India's share in global CGT manufacturing capacity remains limited due to the capital intensity of GMP biologics facilities, shorter product shelf-life, and a nascent talent base in advanced therapy production. Consequently, many Indian drug developers continue to depend on US and European contract manufacturers.
Bharat Biotech believes Nucelion could help ease these constraints and position India as a contributor rather than merely a consumer of breakthrough therapies. By building scalable CGT infrastructure, the company seeks to connect the innovation hubs of the United States, Europe, and Asia, while strengthening India's ambitions to emerge as a regional centre of excellence in advanced biotherapeutics.
Talent Acquisition and Operational Strategy
Nucelion's ongoing hiring plan aims to onboard scientific and operational expertise with global execution experience in CGTs, targeting a niche but highly specialized skill pool. This approach reflects the company's commitment to building world-class capabilities in advanced therapy manufacturing.
For Bharat Biotech, which has established itself as India's leading vaccine manufacturer, Nucelion represents a forward-looking diversification aligned with the global trajectory of precision medicine. As therapies evolve from batch-based manufacturing to personalized treatment models, the company expects demand for high-quality CRDMO support to accelerate sharply in the coming decade.