Bharat Biotech sets up CRDMO arm to focus on cell and gene therapies

Vaccine maker Bharat Biotech has established a contract research development and manufacturing organisation (CRDMO) focused on cell and gene therapies.

Setting up of the wholly-owned subsidiary Nucelion Therapeutics is part of a strategic expansion into the fast-growing field of next-generation cell and gene therapy CRDMO. It 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, Bharat Biotech said announcing the formal launch of the arm on Monday (November 3, 2025).

Nucelion Therapeutics to offer end-to-end services

Spread across a 30,000 sq ft purpose-built facility in Genome Valley, Hyderabad, Nucelion has commissioned a GMP facility capable of developing and manufacturing plasmids, viral and non-viral vectors, cell therapies, and aseptic fill and 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, it 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,” Bharat Biotech founder and non-executive director of Nucelion Therapeutics Krishna Ella said.

Firm hiring scientific, operational talent

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

“We will provide end-to-end solutions from clinical to commercial scale, ensuring regulatory compliance with global standards. The company offers services for development and manufacturing of plasmid DNA, viral vectors, autologous and allogeneic cell therapies,” chief business officer of Nucelion Therapeutics Raghu Malapaka said in a release.