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Home » Bharat Biotech’s Nucelion to Drive Clinical-to-Commercial Cell and Gene Therapy Development

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Bharat Biotech’s Nucelion to Drive Clinical-to-Commercial Cell and Gene Therapy Development

NewsFacts Bureau
Last updated: November 3, 2025 6:28 pm
NewsFacts Bureau
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Bharat Biotech
Bharat Biotech’s Nucelion to Drive Clinical-to-Commercial Cell and Gene Therapy Development
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Hyderabad, India, November 3, 2025: Bharat Biotech has launched Nucelion Therapeutics, a new Contract Research, Development, and Manufacturing Organisation (CRDMO) focused on advancing cell and gene therapies for global markets.

The CRDMO aims to support life science companies with scalable process development and manufacturing solutions for therapies targeting cancers, autoimmune disorders, and rare genetic diseases.

Spread across a 30,000-square-foot purpose-built facility in Genome Valley, Nucelion houses a GMP-compliant plant for the development and manufacturing of plasmids DNA, viral and non-viral vectors, and cell therapies, including aseptic fill and finish. The facility is designed to deliver end-to-end services from early clinical stages to commercial-scale production, in compliance with international standards set by the U.S. FDA and EMA.

Bharat Biotech’s Nucelion Opens in Genome Valley to Support Global CGT Innovation

Dr. Krishna Ella, Non-Executive Director of Nucelion Therapeutics, said, “The future of pharmaceutical innovation will be biological. Our goal is to integrate advanced therapy platforms into India’s healthcare system to create accessible solutions for complex and rare diseases.”

Dr. Raghu Malapaka, Chief Business Officer of Nucelion Therapeutics, added, “Nucelion will offer complete development and manufacturing support for plasmid DNA, viral vectors, and both autologous and allogeneic cell therapies, ensuring global regulatory alignment from clinical to commercial stages.”

Nucelion will function independently with its own leadership, governance, and digital infrastructure. The company plans to engage with Bharat Biotech and other global sponsors on arm’s-length commercial terms. Recruitment is underway to bring in scientific and operational talent experienced in global cell and gene therapy programs.

With this launch, Bharat Biotech expands its footprint in the biological therapeutics segment, positioning Nucelion as a key enabler for advanced therapy manufacturing in India’s growing biotech landscape.

TAGGED:advanced therapiesBharat BiotechbiomanufacturingBiotechnologyCell TherapyCRDMOEMAFDAGene TherapyGenome ValleyGMP manufacturingHyderabadLife SciencesNucelion Therapeuticspharma innovationplasmid DNAviral vectors
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