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Bharat Biotech’s Nucelion to Redefine Cell and Gene Therapy Manufacturing
Bharat Biotech, India’s pioneering Vaccine innovator, has entered the horizons of Cell and Gene Therapy. On November 3, 2025 (Monday), they officially announced the launch of their arm ‘Nucelion Therapeutics’. It is a move that could shape the next era of Biotechnology in India as well as worldwide.
Nucelion Therapeutics is a CRDMO (Contract Research, Development, and Manufacturing Organization). This strategic expansion marks a defining moment not only for Bharat Biotech’s evolution but also for India’s growing prominence as a center for advanced and futuristic therapeutic manufacturing globally.
This strategic expansion marks a defining moment for Bharat Biotech’s evolution as it diversifies into Cell and Gene Therapy, reinforcing India’s position as a hub for next-generation biologics and advanced therapeutic manufacturing.
With this bold move, Bharat Biotech extends its Scientific Research and expertise beyond Vaccines, thereby entering the futuristic, next-generation, as well as advanced therapeutics aimed at providing treatment for Autoimmune Disorders, rare Genetic diseases, as well as cancers.
With this launch, the company would empower leading Global Life Science innovators with Regulatory-compliant, high-quality, and scalable solutions, bridging the significant gap between real-world patient impact and Scientific discoveries.
Expanding into Next-Generation Therapies
This significant launch of ‘Nucelion Therapeutics’ showcases Bharat Biotech’s diversification beyond its established expertise and command over Vaccines.
Nucelion Therapeutics is a specialized CRDMO (Contract Research, Development, and Manufacturing Organization). It is established to accelerate the Scientific transition of Cell and Gene Therapy from R&D (Research & Development) to commercial-scale production.
Non-Executive Director of Nucelion Therapeutics and the founder of Bharat Biotech, Dr. Krishna Ella, stated that, “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. Ella’s statement emphasized the company’s long-term vision: bringing advanced Biological Technologies to India’s Healthcare system, making next-generation therapeutics more locally produced, accessible, as well as affordable. He highlighted the equitable solutions that reflect Bharat Biotech’s broader Philosophy of bridging global innovation with societal impact. This principle has defined the company’s journey from developing affordable Vaccines to now entering the sphere of therapeutic areas.
How Nucelion Therapeutics Aims to Revolutionize Cell and Gene Therapy Manufacturing
It is a purpose-built facility in Genome Valley, Hyderabad, India’s premier Life Sciences center. The advanced, futuristic facility features a GMP (Good Manufacturing Practice)-compliant setup that enables the manufacturing and development of viral and non-viral vectors, plasmids, aseptic fill-and-finish operations, and cell therapies.
‘Nucelion Therapeutics’ aims to accelerate the scientific transition of Cell and Gene Therapy from research and development to commercial-scale manufacturing.
This facility has been designed to offer end-to-end solutions, from early-stage Clinical development to full-scale commercial manufacturing. The company adheres to international Regulatory standards, including those of the US FDA (Food and Drug Administration ) and the EMA (European Medicines Agency). It also aims to ensure that its products and services meet the expectations of its Biopharma partners (both domestic and global).
The GMP-compliant facility in Genome Valley has been built to support Cell and Gene Therapy manufacturing, including plasmid production, viral vector design, and aseptic processing.
Its establishment in Genome Valley, surrounded by a thriving network of Biotechnology startups, companies, and Research organizations, further strengthens its potential to become a central point for collaborative innovation.
Building a Global-Standard CRDMO
As the Biotechnology sector advances, Personalized and Regenerative Medicine, and Compliant and scalable manufacturing have emerged as significant hurdles for innovators in the CGT (Cell and Gene Therapy) sector.
‘Nucelion Therapeutics’ seeks to address this gap by providing comprehensive CRDMO services, offering clients a single platform that supports process optimization, development, production, as well as Analytical testing under strict Quality and Regulatory Frameworks.
The Chief Business Officer of ‘Nucelion Therapeutics’, Raghu Malapaka, stated that “We will provide end-to-end solutions from Clinical to commercial scale, ensuring Regulatory compliance with global standards. The company offers services for the development and manufacturing of plasmid DNA, viral vectors, autologous and allogeneic cell therapies.”
His statement highlights the organization’s commitment to Regulatory Guidelines and Technical excellence, emphasizing its ability to manage both large-scale commercial manufacturing as well as small-batch Clinical production.
Transforming the Future of Medicine Through Cell and Gene Therapy Innovations
The CGT field is rapidly growing from niche treatments for rare diseases into mainstream areas, including Regenerative Medicine, Oncology, as well as Immunology. As delivery systems, manufacturing Technologies, as well as Analytical methods continue to mature, the accessibility and scalability of these therapeutics are expected to improve significantly and exponentially.
Bharat Biotech’s exceptional move to establish ‘Nucelion Therapeutics’ comes at an important moment when demand for specialized CGT manufacturing partners is raging worldwide. By investing in skilled talent and advanced infrastructure, the company is strategically positioning itself to serve Biopharma innovators globally as well as strengthening India’s role in the global Bioeconomy.
A Strategic Leap for Bharat Biotech Toward the Future of Cell and Gene Therapy in India
The establishment of ‘Nucelion Therapeutics’ showcases far more than a corporate expansion; it represents Bharat Biotech’s evolution into the future of Medicine and Healthcare. By investing in Cell and Gene Therapy capabilities, the company is reaffirming its mission to pioneer innovation that transforms lives, not just through Vaccines but through the next wave of Biological breakthroughs.
As global Healthcare moves steadily toward personalized and Regenerative Medicine, ‘Nucelion’ positions Bharat Biotech and India at the heart of this transformation. With its advanced infrastructure, Scientific talent, and unwavering vision, the company is set to redefine how the world perceives innovation born in India, precise, powerful, and profoundly human.
