Bharat Biotech launches Nucelion to tap fast-growing cell & gene therapy manufacturing market

Bharat Biotech International Ltd has forayed deeper into advanced biologics with the launch of Nucelion Therapeutics Pvt Ltd, a wholly owned Contract Research, Development and Manufacturing Organisation (CRDMO) dedicated to cell and gene therapy (CGT) development and production.

Positioned as a next-generation manufacturing partner for global biopharma innovators, the launch underscores a significant strategic expansion by the Covaxin maker into one of the fastest-growing segments of the pharmaceutical industry.

Nucelion begins operations from a 30,000 sq. ft. purpose-built GMP facility in Genome Valley, India’s largest lifesciences cluster, which has steadily evolved into a preferred hub for R&D and biomanufacturing. The company will offer a full 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 — supporting clients right from early clinical phases to global commercial supply. Importantly, 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 has emphasised that it will operate with independent governance, leadership and information systems, and maintain arm’s-length commercial relationships with all clients, including its parent Bharat Biotech. Its ongoing hiring plan aims to onboard scientific and operational expertise with global execution experience in CGTs — a niche but highly specialised skill pool.

As the pharmaceutical industry transitions from chemical-based therapies to more complex biologics, the pipeline of cell and gene therapies has expanded rapidly. Industry trackers estimate that the global CGT market is growing at double-digit CAGR, fuelled by manufacturing and analytical advancements that are enabling what was once confined to rare, ultra-expensive treatments to move into broader therapeutic areas. The momentum is most pronounced in oncology, immunology and regenerative care, where scalable platforms are now emerging to support mass-market access.

Dr. Krishna Ella, Non-Executive Director of Nucelion Therapeutics, highlighted the long-term shift in medical innovation, stating, “The future of pharmaceutical innovation will be biological; CGTs are a key vector. Our vision is to integrate advanced therapy platforms into India’s healthcare ecosystem, enabling equitable solutions for complex and rare diseases.”

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 — not merely a consumer — of breakthrough therapies.

Adding to this, Dr. Raghu Malapaka, Chief Business Officer of Nucelion, said, “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.”

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. Analysts believe that increasing biomanufacturing depth, combined with India’s cost advantages, could help attract global outsourcing mandates — particularly at a time when the CGT industry is grappling with limited production capacity, long wait times and pricing pressures.

For Bharat Biotech, which has already 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 personalised treatment models, the company expects demand for high-quality CRDMO support to accelerate sharply in the coming decade.

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