Bharat Biotech Launches Nucelion for Cell, Gene Therapy Market

Bharat Biotech International Ltd has broadened its biologics portfolio to include the launch of Nucelion Therapeutics Pvt Ltd, a 100% owned contract research, development, and manufacturing organization (CRDMO) that focuses on the development and production of cell and gene therapy (CGT).

Nucelion, located in a 30,000 sq. ft. GMP facility in Genome Valley, India's leading life sciences hub, will provide full-spectrum manufacturing capabilities, i.e., plasmid DNA, viral and non-viral vectors, autologous and allogeneic cell therapies, and aseptic fill and finish. The facility is designed according to the US FDA and EMA regulatory requirements, so it can serve both local and international clients.

Moreover, Nucelion will be working independently with its management and board of directors, and maintaining a commercial arm’s-length relationship with Bharat Biotech. The company is looking forward to hiring a team of professionals with worldwide CGT implementation expertise.

According to Dr. Krishna Ella, Non-Executive Director of Nucelion Therapeutics, "The next generation of pharmaceutical innovations will be biologics; CGTs are a major driver. Our goal is to deploy India advanced therapy platforms healthcare ecosystem, which in turn would provide the most affordable solutions for difficult and rare diseases."

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Dr. Raghu Malapaka, Chief Business Officer of Nucelion, also shares his thoughts, "Nucelion is committed to offering complete solutions for clinical and commercial scale, while adhering to global standards (FDA, EMA)."

Bharat Biotech through Nucelion wants to make India not only a regional but also a global hub of advanced bio therapeutics by connecting global innovation centres with the country’s bio manufacturing capabilities.