Bharat Biotech Launches New CRDMO Division
Bharat Biotech International has set up Nucelion Therapeutics, a Contract Research Development and Manufacturing Organization (CRDMO) focused on cell and gene therapies as its wholly owned subsidiary.
The CRDMO, located in the Genome Valley, 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.
“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,’’ Krishna Ella, Non-Executive Director, Nucelion Therapeutics says.
According to Raghu Malapaka, Chief Business Officer, Nucelion Therapeutics, the new company would provide end-to-end solutions from clinical to commercial scale, ensuring regulatory compliance with global standards (FDA, EMA). It offers services for the development and manufacturing of plasmid DNA, Viral Vectors, Autologous and Allogeneic Cell Therapies.
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.
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It will operate with independent leadership, governance and information systems, and will engage all sponsors—including Bharat Biotech—on arm’s-length commercial terms.
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The company’s talent acquisition is underway to onboard scientific and operational talent with global experience in cell and gene therapy execution, according to a release.
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The launch of Nucelion Therapeutics represents a major milestone in India’s biotechnology ecosystem, aligning with the country’s goal of becoming a global leader in advanced biopharmaceuticals. By combining research, innovation, and world-class manufacturing, Bharat Biotech aims to make India a hub for affordable and globally competitive biomedical solutions.