Takara Bio Submits Drug Master File to the U.S. FDA for RetroNectin® GMP grade (Solution Type)

Kusatsu/Shiga, Japan — April 3, 2019 – Takara Bio Inc. (Takara Bio) announced that it has submitted a Drug Master File (DMF) to the Food and Drug Administration (FDA) for “RetroNectin~{®}  GMP grade” (Solution type) as of March 15, 2019.

 

  Cancer immune-gene therapy such as CAR gene therapy, one of cancer immune therapy, becomes a focus of attention on cancer therapy. In manufacturing process of cancer immune-gene therapy products, T cells which are responsible for immune homeostasis capable of recognizing and attacking cancer cells, etc. are taken from the patients and transduced with gene intended for strengthening the function. The gene-transduced cells are subject to the expansion culture and infused back to the patients. RetroNectin~{®}  is effective in manufacturing cancer immune-gene therapy products, and Takara Bio is licensing out of its technology to companies, etc. seeking to develop and commercialize gene therapies.

 

  The RetroNectin~{®}  GMP grade  (Solution type)　is following RetroNectin~{®}  (Freeze-dried type) submitted in advance and is manufactured as a recombinant protein at Takara Bio's facility in Kusatsu, Shiga, Center for Gene and Cell Processing in accordance with GMP/GCTP Standards for Manufacturing Control and Quality Control for Pharmaceuticals and Regenerative Medical Products that satisfy certain criteria in manufacturing pharmaceuticals.

 

  Takara Bio will make further efforts for Bioindustry business expansion through line-up of products and services, supporting research and development in the regenerative medicine field including cancer immune-gene therapy from basic research to clinical application.

 

【Overview of Submission】