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

MOUNTAIN VIEW, Calif. /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. 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."

[Overview of Submission]

Subject

RetroNectin GMP grade

Submission date

March 15, 2019

Application type/number

DMF 18898


About Takara Bio

Takara Bio USA, Inc. (TBUSA; formerly Clontech Laboratories, Inc.) is a wholly owned subsidiary of Takara Bio Inc. that manufactures and distributes kits, reagents, and instruments for life sciences research applications, including NGS, PCR, gene delivery, genome editing, stem cell research, nucleic acid and protein purification, and automated sample preparation.

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Takara Bio Inc

Takara Bio Inc., a world leader in biotechnology research and development, offers a host of life science research solutions, from enzymes and GMP reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology.