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Immuneel sets up cell therapy development and production facility

Immuneel Therapeutics Private Limited (Immuneel) on Monday announced setting up of the country’s first Integrated Cell Therapy Development and Manufacturing Facility here in Narayana Hrudayalaya Health City.

The 12,000-sq.ft. integrated facility includes a state-of-the-art laboratory, cGMP-compliant manufacturing suites which will bring breakthrough cell and gene therapies to millions of patients in India.

The facility is compliant with Indian Gene Therapy Product (GTP) guidelines released in 2019 and Global cGMP guidelines for advanced therapy medicinal products (ATMP) published by EMA and USFDA with a focus on manufacturing and quality systems specific to cell therapies, according to a press release here on Monday.Dr Renu Swarup, (Secretary, Department of Biotechnology, Govt. of India) inaugurated the facility in the presence of Dr Devi Shetty (Chairman, Narayana Health), Ms Kiran Mazumdar Shaw (Co-Founder, Immuneel Therapeutics) & Dr Arun Anand (COO, Immuneel Therapeutics).

In her keynote address Dr Renu Swarup said “Immuneel’s facility inauguration is a significant milestone for India as it enables the country to have an integrated facility that develops advanced technologies and delivers cutting edge therapies. Immuneel’s mission of providing affordable, high quality therapy fulfils the ambitions of the Government’s Atmanirbhar Bharat program towards a self-reliant nation that also serves the world. Immuneel will play a role as the central anchor for cell & gene therapy in India.”

In his address, Dr Devi Shetty said, “Immuneel has created an edifice for the future within Narayana Health City with the singular aim of saving precious lives using transformative therapies like CAR-T cell therapies.”

Speaking on the occasion, Biocon Chief Kiran Mazumdar Shaw said, “The inauguration of this fully integrated facility is a proud milestone for Immuneel Therapeutics and for India as we bring a breakthrough innovation like CAR-T therapy to cancer patients in India. Immuneel is committed to providing affordable access to this cutting-edge therapy at its state-of-the-art facilities housed at the Mazumdar Shaw Medical Centre. Immuneel is keen to play a key role in capability and capacity building for the nation in partnership with the Department of Biotechnology and lead the way in building an eco-system to deliver translational cell and gene therapy.

”Dr Arun Anand COO, Immuneel Therapeutics said, “Immuneel has built an integrated facility that is amongst the best in the world, and that can potentially transform lives through its centralized and strategic location harnessing the potential of physicians, scientists and information technology companies to deliver cutting edge therapies. Along with setting up this world class facility, Immuneel has also attracted exceptional global talent with prior experience in cell therapy in pursuit of our mission to deliver affordable cell therapies such as CAR-T therapy to patients in India.”

The multi-product multi-process facility will currently focus on autologous cell therapies including CAR-T cell therapy for lymphomas & leukemias (heme malignancies) and in future other forms of solid tumors, allogeneic cell therapy and beyond cell therapy and oncology in future. The Center of Excellence for cell manufacturing will ensure reproducibility, scalability, data integration for optimizing efficiency and monitoring performance which will bring in high-quality, world class, cost-effective cell therapy manufacturing capability. – UNI

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