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

Mountain View, CA—April 11, 2019—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. RetroNectin reagent enables the effective viral transduction of gene products into T lymphocytes and the expansion of naïve T-cell populations in culture.

The liquid format of RetroNectin GMP grade, a follow-up to the lyophilized version developed in 1995, is a recombinant human fibronectin fragment manufactured as a quality-assured product, according to relevant guidelines for Good Manufacturing Practice.

"Takara Bio is pleased to offer an extensive portfolio of products and services that accelerate regenerative medicine research and development including cancer immunotherapies," said Carol Lou, President of Takara Bio USA, Inc. "RetroNectin reagent has already been used in over 50 clinical trials, and the Drug Master File will make its use simpler for clinical investigators."