Mon Nov 03 07:48:51 UTC 2025: Summary:

Bharat Biotech, the vaccine manufacturer, has launched Nucelion Therapeutics, a contract research development and manufacturing organisation (CRDMO) specializing in cell and gene therapies. Located in Genome Valley, Hyderabad, Nucelion boasts a 30,000 sq ft facility and aims to provide end-to-end services for global life science innovators, from early clinical development to commercial-scale manufacturing. The CRDMO will adhere to international regulatory standards and focus on cancers, autoimmune disorders, and rare genetic disorders.

News Article:

Bharat Biotech Enters Cell & Gene Therapy Space with Nucelion Therapeutics

HYDERABAD, INDIA – November 3, 2025 – Indian vaccine giant Bharat Biotech has officially launched Nucelion Therapeutics, a wholly-owned subsidiary designed to function as a contract research development and manufacturing organisation (CRDMO) specializing in advanced cell and gene therapies (CGTs). The move signals Bharat Biotech’s strategic expansion into the rapidly evolving and promising field of next-generation therapies.

Nucelion Therapeutics will provide end-to-end services to global life science innovators, encompassing everything from early-stage clinical development to commercial-scale manufacturing. The company’s focus will be on developing treatments for cancers, autoimmune disorders, and rare genetic disorders.

“The future of pharmaceutical innovation will be biological,” said Krishna Ella, Bharat Biotech founder and non-executive director of Nucelion Therapeutics. “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.”

Located in Genome Valley, Hyderabad, the CRDMO’s purpose-built, 30,000 sq ft facility boasts a GMP facility capable of developing and manufacturing plasmids, viral and non-viral vectors, cell therapies, and aseptic fill and finish. The company plans to operate with independent leadership and governance, ensuring transparency with all sponsors, including Bharat Biotech, on commercial terms.

“We will provide end-to-end solutions from clinical to commercial scale, ensuring regulatory compliance with global standards,” said Raghu Malapaka, Chief Business Officer of Nucelion Therapeutics. The company’s services will include the development and manufacturing of plasmid DNA, viral vectors, and both autologous and allogeneic cell therapies.

The launch of Nucelion Therapeutics marks a significant step for Bharat Biotech and reinforces India’s growing presence in the global biotechnology landscape. The company is currently recruiting scientific and operational talent with international expertise in cell and gene therapy execution.

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