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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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