Bharat Biotech Launches Nucelion Therapeutics for Cell and Gene Therapy Manufacturing

• Bharat Biotech International Ltd has launched Nucelion Therapeutics , a wholly owned subsidiary focused on cell and gene therapy manufacturing . Based in Hyderabad’s Genome Valley , Nucelion will function as a Contract Research, Development and Manufacturing Organisation (CRDMO) , providing comprehensive services for the development and production of advanced biological treatments. The initiative marks Bharat Biotech’s strategic entry into next-generation therapeutic technologies, expanding India’s footprint in the global biopharmaceutical sector.

Focus on Advanced Therapies

• Nucelion Therapeutics aims to support innovation in oncology, autoimmune disorders, and rare genetic diseases . The company will offer end-to-end capabilities from research and development to large-scale production of advanced therapies. Bharat Biotech’s Non-Executive Director Dr. Krishna Ella described the launch as a step toward integrating cutting-edge therapy platforms into India’s healthcare ecosystem. He emphasized that the “future of pharmaceutical innovation will be biological,” underscoring the company’s vision of ensuring affordable access to life-changing treatments .

State-of-the-Art Infrastructure

• The facility in Genome Valley is equipped with Good Manufacturing Practice (GMP) -compliant infrastructure and meets the US FDA and European Medicines Agency (EMA) regulatory standards. It includes advanced capabilities for plasmid production, viral and non-viral vector manufacturing, autologous and allogeneic cell therapies , as well as aseptic fill and finish operations . These systems enable Nucelion to support projects from pre-clinical research to commercial manufacturing , ensuring quality, scalability, and regulatory compliance.

Independent Operations and Global Collaboration

• According to Raghu Malapaka , Chief Business Officer of Nucelion, the company will function independently with its own leadership, governance, and IT systems, though it will collaborate with Bharat Biotech on commercial terms. The company aims to attract global scientific and technical talent to strengthen India’s position in biomanufacturing and life sciences innovation .

Exam- Facts

• Bharat Biotech launched Nucelion Therapeutics in November 2025 .

• Located in Genome Valley, Hyderabad .

• Functions as a CRDMO specializing in cell and gene therapy .

• Facility meets GMP, US FDA, and EMA standards.

• Krishna Ella is Non-Executive Director; Raghu Malapaka is Chief Business Officer.

Strengthening India’s Biotech Ecosystem

The launch of Nucelion Therapeutics represents a major milestone in India’s biotechnology ecosystem , aligning with the country’s goal of becoming a global leader in advanced biopharmaceuticals . By combining research, innovation, and world-class manufacturing, Bharat Biotech aims to make India a hub for affordable and globally competitive biomedical solutions .