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Hyderabad Vaccine maker Bharat Biotech International Ltd (BBIL) has set up India’s only vertically integrated, purpose-designed Cell & Gene Therapy (C>) Infrastructure & Viral Vector Production facility in Genome Valley here with an investment of $75 million. “With this, we are moving beyond vaccine innovation to leading-edge regenerative and personalised therapies that promise hope for millions,’‘ Krishan Ella, Executive Chairman, Bharat Biotech told newspersons after the formal inauguration of the facility. “Gene and cell therapies represent some of the most intricate, scientifically advanced treatments available today and process of vaccine production is almost similar to the cell culture and we can use our domain knowledge for innovation in C>,’‘ Ella said adding that Bharat Biotech is the only company in the developing world which conducted about 150 clinical trials in 20 countries.
“The initiative will enable the rapid translation of advanced scientific discoveries—from potent therapeutic vectors to in vivo CAR (chimeric antigen receptor) generation—into real-world solutions,’‘ he said, adding that the regulatory framework in India should facilitate research and innovation in the segment. According to Raches Ella, Chief Development Officer, Bharat Biotech who heads the CGT initiative, the new facility was designed to produce high-titer viral vectors (AAV, Lentivirus, Adenovirus), which are essential for cell and gene therapy applications - the crucial material for anti-cancer and genetic disorders and robust clinical development abilities for QC releases. “Additionally, it has capabilities to manufacture multiple platform products for various disease indications, including blood cancers, solid organ cancers, and genetic disorders,’‘ he said adding that the high cost of C> (about ₹50 lakh for a product) could be further brought down with indigenous production.
Bharat Biotech now has five products in the pipeline - two in cell culture and three in the gene therapy segment. “We expect the first product to be rolled out subject to successful completion of the trials and other regulatory approvals,’‘ Ella said. The company has entered into a research collaboration with the University of Wisconsin- Madison, US which can be later expanded to commercial pacts including in-licencing.
Down the line, the company would also explore the export potential and opportunity in medical tourism in the segment. Oncology and rare diseases treatment therapies will be key focus areas for Bharat Biotech in C> and the facility will support a wide array of advanced therapies, including CD19 CAR T cell therapy for blood cancers and gene therapy. Explaining the significance of the next generation C>, Krishanu Saha, Scientist from University of Wisconsin- Madison, said: “My lab has initiated a pioneering collaboration with Bharat Biotech to develop next-generation CAR cell therapies using AI.
Ultimately, genuine innovations in both product design and scaling will enhance patient care globally.” The 50,000 sq-ft dedicated state-of-the-art CGT facility has GMP certification and a clean room facility and will help address unmet clinical needs globally by concentrating on critical conditions such as hematological malignancies and inherited blood disorders. Comments.
