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US-based ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, has announced that Immuneel Therapeutics has been awarded a $150,000 G-Rex grant to support process development aimed at enhancing the scalability and cost-effectiveness of CAR-T cell manufacturing in India.
"The blood cancer burden on India's population is substantial, around 120,000 new cases of lymphoma, leukemia, and multiple myeloma are diagnosed each year. Unfortunately, almost 70,000 Indians will die every year from these afflictions, devastating the lives of their families and communities. To afford access to all Indian patients in need, and to capitalise on the immense commercial potential of our pipeline, we need to think prudently and practically about our manufacturing approach. In the short term, our manufacturing demands are almost 200 drug products per day, and this may increase as CAR-T cell therapies move closer to front line treatment. The only practical way for us to industrialize our production and produce a supply of drug product commensurate with total patient demand is to transition to G-Rex," said Dr. Lakshmikanth Gandikota, Head of R&D, MSAT Intellectual Property, and Translational Research, at Immuneel Therapeutics Limited.
As part of Immuneel's G-Rex Grant, Immuneel will perform process development, qualification, and validation of a G-Rex based CAR-T cell therapy production approach to dramatically increase the throughput capacity of their state-of-the-art, 12,000 square foot GMP facility.
Located in Bengaluru and opened in 2021, Immuneel's Integrated Cell Therapy Development and Manufacturing Facility was the first of its kind in India and is designed to bring breakthrough cell and gene therapies to millions of patients in India.
Lastly, Immuneel's G-Rex Grant will support the requisite comparability studies necessary to support a post-CAR-T approval manufacturing change from their difficult to scale low throughput all-in-one manufacturing equipment to a much simpler high throughput G-Rex centric approach.
