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Bharat Biotech International Limited (BBIL), a pioneer in affordable indigenous vaccine development and manufacturing, announced today the launch of India's only vertically integrated, purpose-designed Cell and Gene Therapy (CGT) Infrastructure and Viral Vector Production Facility at Genome Valley in Telangana's Hyderabad expanding its expertise from vaccine innovation to leading-edge regenerative and personalised therapies that promise hope for millions, said a release.
As per the release, this facility ushers in a new era of gene and cell therapies to tackle scientific challenges such as targeted gene expression, immune system modulation, and long-term cell survival. The work will span from boosting immune responses against cancer to ensuring that therapeutic proteins are safely accepted in patients with genetic diseases like haemophilia. The 50,000-square-foot dedicated state-of-the-art CGT facility represents the next milestone in BBIL's long-standing mission to deliver targeted, life-saving treatments that address unmet clinical needs globally by concentrating on critical conditions such as haematological malignancies and inherited blood disorders. Outlining the purpose behind establishing India's only vertically integrated cell and gene therapy facility, Dr. Krishna Ella, Executive Chairman, of Bharat Biotech, said, "Gene and cell therapies represent some of the most intricate, scientifically advanced treatments available today, involving sophisticated processes that require expertise in precise genetic manipulation and specialized manufacturing capabilities. Bharat Biotech, with its extensive experience and proven excellence in viral vaccine manufacturing, is uniquely positioned to master these complexities and produce human-grade vectors at the scale and consistency needed for clinical trials, thus advancing the global fight against rare and complex diseases." Dr. Raches Ella, Chief Development Officer, Bharat Biotech, spearheading this CGT initiative, said, "Bharat aims to democratize gene therapies, traditionally considered prohibitively expensive and available primarily in developed nations or premium institutions. Our CGT facility is 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." Prof. Krishanu Saha, University of Wisconsin, Madison, said: "Innovations in biomanufacturing for potentially curative cell and gene therapies originate worldwide. It's thrilling to witness the expertise and commitment to developing and scaling novel ideas in India, particularly at Bharat Biotech. My lab has initiated a pioneering collaboration with Bharat Biotech to develop next-generation CAR (chimeric antigen receptor) cell therapies using AI. Ultimately, genuine innovations in both product design and scaling will enhance patient care globally. "For decades, Bharat Biotech has led India's effort in developing and manufacturing affordable vaccines for critical diseases. "The new CGT facility aligns with BBIL's broader vision of expanding beyond traditional vaccines into personalized medicine. Leveraging our proven expertise in forging strategic global partnerships, this 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," said Dr Ella. Describing the CGT focus Areas to meet the demand for complex disease treatments, Dr.Raches added, "Oncology & Rare Diseases treatment therapies are our key focus areas. This facility will support a wide array of advanced therapies, including CD19 CAR T Cell Therapy for Blood cancers and Gene Therapy. Leveraging this deep expertise, Bharat Biotech is not only bridging the gap between scientific innovation and mass affordability but also reaffirming its enduring commitment to democratizing healthcare for the nation and beyond." The key differentiators and technological innovations include expert collaborations, where a world-renowned scientific advisory board and global research partners guide us on the latest genome editing and cell manufacturing technologies. The facility is equipped for advanced viral vector production, designed to produce high-titer viral vectors such as AAV, Lentivirus, and Adenovirus, which are essential for cell and gene therapy applications. An integrated quality assurance system is in place, with specialized teams overseeing both upstream and downstream processes to ensure regulatory compliance and deliver viral vectors that meet the highest standards for clinical use. Additionally, the scalable infrastructure is designed to accommodate continuous expansion as CGT research evolves and demand increases. Additionally, multiple specialized teams--spanning process development, production, quality assurance, and quality control--will collaborate under one roof to drive the clinical translation of novel therapies. Full-scale operations are on track to commence as the facility finalizes regulatory approvals and completes the remaining build-out phases, the release added. (ANI)
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