Takara Bio submits Drug Master File to US FDA for RetroNectin® GMP grade (liquid format)

PRNEWSWIRE | April 11, 2019

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MOUNTAIN VIEW, Calif., April 11, 2019 /PRNewswire/ --Takara Bio USA, Inc.  announced today that its parent company, Takara Bio Inc., submitted a Drug Master File to the Food and Drug Administration for the liquid formulation of RetroNectin GMP grade on March 15, 2019. cancer immunotherapies, such as CAR T-cell therapy, have become a major focus in the battle against cancer. In the manufacturing of such therapies, the patient's T cells—responsible for immune homeostasis—are extracted, modified to recognize and target tumor cells, then infused back into the patient. Before infusion, the gene-transduced cells are expanded in culture. 


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