Fate Therapeutics Initiated cGMP for iPSC Derived Cell Therapies

Release Date: 04-Oct-2019

Recently, On 30 September 2019, Fate Therapeutics, Inc., initiated current Good Manufacturing Process (cGMP) compliant manufacturing facility for the clinical production of iPSC derived products such as natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates. Fate therapeutic is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders.


Further, cGMP facility of the company is located in San Diego, California, and is custom designed for the manufacture of off-the-shelf allogeneic cell products using clonal master induced pluripotent stem cell (iPSC) lines as a starting cell source. Now the Company got a licence of drug manufacturing by the State of California, Department of Health Services, Food and Drug Branch.


According to the Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics, the on-time launch of our cGMP manufacturing facility is a significant milestone that positions the Company as the leading manufacturer and developer of off-the-shelf NK cell and CAR-T cell cancer immunotherapies. With full control of cGMP production, combined with our proven ability to genetically-engineer induced pluripotent stem cells and create clonal master iPSC banks qualified for clinical use, we believe we have established operational capabilities unique to the industry to ensure consistent, large-scale, and cost-effective manufacture of best-in-class off-the-shelf cell products for on-demand delivery to patients.


Fate therapeutics is emerging as a developed and advanced company in the sector of Stem Cell Therapeutics. Recently, Fate Therapeutics announced that FDA cleared the Investigational New Drug (IND) application of the company for its new iPSC-derived CAR-NK cell product candidate, known as FT596. This product is engineered to target multiple tumor-associated antigens and may be used in the management of B-cell lymphoma and chronic lymphocytic leukemia.


Further, the Company is also conducting first-in-human clinical trials of FT516, which is a new, iPSC-derived NK cell product candidate. The product is engineered to express a novel high-affinity towards CD16 (hnCD16) Fc receptor, for the treatment of acute myeloid leukemia and B-cell lymphoma. Another product in development phase is FT500, which is studied for management of advanced solid tumors.

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