18 January 2021 | News
This multi-product multi-process facility will currently focus on autologous cell therapies including CAR-T cell therapy for lymphomas & leukemias
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Immuneel Therapeutics Private Limited (Immuneel) has announced the inauguration of India's first Integrated Cell Therapy Development and Manufacturing Facility in Bengaluru.
Located 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.
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).
This multi-product multi-process facility will currently focus on autologous cell therapies including CAR-T cell therapy for lymphomas & leukemias (haeme 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.
In her keynote address Dr Renu Swarup, Secretary Department of Biotechnology, Govt. of India, said “Immuneel’s facility inauguration is a significant milestone for India as it enables India 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.”