Bharat Biotech forays into CRDMO space with new cell & gene therapies arm Nucelion Therapeutics

HYDERABAD: Vaccine maker Bharat Biotech is foraying into the contract research development and manufacturing organisation (CDRMO) space with the setting up of a new wholly-owned subsidiary, Nucelion Therapeutics Pvt Ltd, that is focused on cell and gene therapies (CGT).Announcing its entry into this high growth CRDMO segment, Bharat Biotech said the new entity will 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.Housed in a 30,000 sq ft purpose-built facility in Genome Valley, Nucelion has already commissioned a GMP facility with a capacity to develop and manufacture plasmids, viral and non-viral vectors, cell therapies, and aseptic fill & finish.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 US FDA and Europe’s EMA.Bharat Biotech founder chairman and Nucelion Therapeutics non-executive director Dr Krishna Ella 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.”Nucelion Therapeutics chief business officer Dr Raghu Malapaka said the CRDMO player will offer services for the development and manufacturing of plasmid DNA, viral vectors, autologous, and allogeneic cell therapies.“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 programmes to scalable platforms, expanding from rare diseases into broader oncology, immunology, and regenerative care as manufacturing, analytics, and delivery technologies mature,” Bharat Biotech said.