Bharat Biotech Expands into Cell & Gene Therapy with Launch of Nucelion Therapeutics

Bharat Biotech International Ltd, a prominent player in the Indian pharmaceutical industry, has made a strategic move into the rapidly growing field of cell and gene therapy. The company has launched Nucelion Therapeutics Pvt Ltd, a wholly owned Contract Research, Development and Manufacturing Organisation (CRDMO) focused on cell and gene therapy development and production.

Key Features of Nucelion Therapeutics

• Facility: 30,000 sq. ft. GMP facility located in Genome Valley
• Services Offered:
  • Plasmid DNA manufacturing
  • Viral and non-viral vector production
  • Autologous and allogeneic cell therapies
  • Aseptic fill & finish services
• Regulatory Compliance: Adheres to US FDA and European Medicines Agency frameworks
• Market Focus: Serves both domestic and international markets

Strategic Importance

Bharat Biotech's launch of Nucelion Therapeutics represents a significant expansion into advanced biologics and precision medicine. This move is particularly noteworthy given the current landscape of the cell and gene therapy (CGT) market:

• The global CGT market is experiencing double-digit Compound Annual Growth Rate (CAGR)
• Momentum is particularly strong in oncology, immunology, and regenerative care
• India's share in global CGT manufacturing capacity remains limited due to capital intensity and talent constraints

Operational Structure

To ensure transparency and fair practices, Nucelion Therapeutics will:

• Operate with independent governance
• Maintain arm's-length commercial relationships with all clients, including parent company Bharat Biotech

Market Impact

The launch of Nucelion Therapeutics could potentially address a significant gap in the Indian CGT manufacturing landscape. Currently, many Indian developers rely on US and European contract manufacturers for their CGT production needs. Nucelion's establishment may offer a domestic alternative, potentially reducing costs and increasing accessibility for Indian companies in this cutting-edge field.

Conclusion

Bharat Biotech's strategic expansion into cell and gene therapy manufacturing through Nucelion Therapeutics demonstrates the company's commitment to staying at the forefront of biotechnology innovation. This move not only diversifies Bharat Biotech's portfolio but also positions it to capitalize on the growing global demand for advanced biological therapies. As the CGT market continues to evolve, Nucelion Therapeutics may play a crucial role in enhancing India's capabilities in this high-potential sector.