Hyderabad-based vaccine major Bharat Biotech has announced the launch of its new contract research, development, and manufacturing organisation (CRDMO) — Nucelion Therapeutics — dedicated to advancing cell and gene therapy (CGT) research and production.
Strategic Expansion into Advanced Therapies
As reported by The Hindu, the establishment of Nucelion Therapeutics, a wholly owned subsidiary, marks Bharat Biotech’s strategic entry into the fast-growing global market for next-generation cell and gene therapies. The new venture aims to support life science innovators worldwide by offering scalable process development and manufacturing solutions for advanced therapies targeting cancers, autoimmune disorders, and rare genetic diseases.
Announcing the launch on November 3, 2025, Bharat Biotech stated that the initiative reflects its commitment to expanding India’s footprint in high-value biotherapeutics.
World-Class Facility in Genome Valley
Located in Genome Valley, Hyderabad, Nucelion Therapeutics operates from a 30,000 sq ft purpose-built facility equipped with a Good Manufacturing Practice (GMP)-certified unit. The facility is capable of developing and manufacturing plasmids, viral and non-viral vectors, and cell therapies, along with aseptic fill and finish operations.
By offering end-to-end services, Nucelion will guide clients from early-stage clinical development to commercial-scale manufacturing, ensuring compliance with international regulatory standards, including FDA and EMA guidelines.
Vision for the Future of Biopharmaceuticals
“The future of pharmaceutical innovation will be biological, and cell and gene therapies are key vectors of that future,” said Dr. Krishna Ella, Founder of Bharat Biotech and Non-Executive Director of Nucelion Therapeutics. “Our vision is to integrate advanced therapy platforms into India’s healthcare ecosystem, enabling equitable solutions for complex and rare diseases.”
Focus on Global-Standard Expertise
As cell therapy technologies mature, autologous, allogeneic, and in vivo approaches are expected to transition from niche programs to scalable platforms across oncology, immunology, and regenerative medicine. Recognizing this shift, Nucelion Therapeutics will operate with independent leadership, governance, and information systems while maintaining arm’s-length commercial relations with Bharat Biotech.
The firm is actively recruiting scientific and operational talent with global experience in cell and gene therapy execution, reflecting its intent to build a world-class multidisciplinary team.
Offering End-to-End CGT Solutions
Raghu Malapaka, Chief Business Officer of Nucelion Therapeutics, emphasized the company’s commitment to global excellence:
“We will provide end-to-end solutions from clinical to commercial scale, ensuring full regulatory compliance with international standards. Our services span the development and manufacturing of plasmid DNA, viral vectors, and both autologous and allogeneic cell therapies.”
With Nucelion Therapeutics, Bharat Biotech aims to position India as a global hub for advanced therapy manufacturing, bridging the gap between scientific innovation and accessible healthcare solutions.