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Bharat Biotech's Nucelion: Launching India's Next-Gen Cell and Gene Therapy Hub

Bharat Biotech has officially launched its new subsidiary, Nucelion Therapeutics. This Hyderabad-based company will operate as a contract research, development and manufacturing organization. It features a 30,000 square foot facility equipped for developing advanced cell and gene therapies. Nucelion aims to provide end-to-end services from early clinical development to commercial manufacturing.

Key Points: Bharat Biotech Launches Nucelion Cell and Gene Therapy CRDMO

  • New 30,000 sq ft GMP facility in Hyderabad's Genome Valley
  • Offers plasmid DNA and viral vector development and manufacturing
  • Focuses on therapies for cancer and rare genetic disorders
  • Provides end-to-end services from clinical to commercial scale
2 min read

Bharat Biotech launches Nucelion, the Next-Gen Cell and Gene Therapy CRDMO

Bharat Biotech launches Nucelion, a Hyderabad-based CRDMO offering end-to-end cell and gene therapy development and manufacturing for global innovators.

"The future of pharmaceutical innovation will be biological; CGTs are a key vector. - Dr. Krishna Ella"

Hyderabad, November 3

Nucelion Therapeutics Pvt Ltd, a newly established Hyderabad-based Contract Research, Development, and Manufacturing Organisation (CRDMO) focused on cell and gene therapies, announced its formal launch on Monday.

Nucelion is a wholly owned subsidiary of Bharat Biotech International Ltd.

The CRDMO aims to support global life science innovators with high-quality, scalable process development and manufacturing solutions for advanced therapies, indicated for cancers, autoimmune disorders, and rare genetic disorders, according to a press release issued by Bharat Biotech.

The future of pharmaceutical innovation will be biological, with new modalities expected to drive a large share of growth worldwide. Within this shift, cell therapies--autologous, allogeneic, and emerging in vivo approaches--are poised to move from niche programs to scalable platforms, expanding from rare diseases into broader oncology, immunology, and regenerative care as manufacturing, analytics, and delivery technologies mature.

Spread across a 30,000 square foot purpose-built facility in Genome Valley, Nucelion has commissioned a GMP facility capable of developing and manufacturing plasmids, viral and non-viral vectors, cell therapies, and aseptic fill & finish, providing end-to-end services for clients. The company will offer end-to-end services, from early-stage clinical development to commercial-scale manufacturing, while adhering to international regulatory standards, including those of the FDA and EMA.

Dr. Krishna Ella, Non-Executive Director, Nucelion Therapeutics, said, "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."

Dr. Raghu Malapaka, Chief Business Officer, Nucelion Therapeutics, said, "At Nucelion, we will provide end-to-end solutions from clinical to commercial scale, ensuring regulatory compliance with global standards (FDA, EMA). Nucelion offers services for the development and manufacturing of plasmid DNA, Viral Vectors, Autologous, and Allogeneic Cell Therapies.

Nucelion will operate with independent leadership, governance, and information systems, and will engage all sponsors--including Bharat Biotech--on arm's-length commercial terms. The company's talent acquisition is underway to onboard scientific and operational talent with global experience in cell and gene therapy execution.

- ANI

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Reader Comments

R
Rohit P
Great initiative but I hope the focus remains on making these advanced therapies accessible to common Indians. Often such high-tech treatments remain out of reach due to costs. Hope Nucelion works on pricing models that consider our economic diversity.
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Sarah B
As someone working in pharmaceutical research, this is exactly what India needs. The 30,000 sq ft GMP facility with end-to-end capabilities shows serious commitment. The arm's-length commercial terms with Bharat Biotech is a smart governance move for credibility.
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Arjun K
Dr. Krishna Ella and team are visionaries! From Covaxin to now cell and gene therapies - they're building India's biotech ecosystem systematically. The focus on cancers and rare genetic disorders could be life-changing for so many families. Jai Hind! 💪
M
Michael C
Impressive scale and vision. The mention of FDA and EMA compliance shows they're thinking globally. Hope this attracts more international pharma companies to partner with Indian firms. Could be a game-changer for India's pharmaceutical exports.
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Kavya N
My brother has a rare genetic condition and we've been exploring treatment options abroad. If Nucelion can develop therapies for such conditions in India, it would save families like ours from the huge financial burden of overseas treatment. Fingers crossed! 🤞
D

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