Release of GMP grade PCR enzyme for genetic diagnosis

Kusatsu/Shiga, Japan – January 25, 2016 – Takara Bio has manufactured and quality-controlled GMP-grade high quality PCR enzyme, “TaKaRa Taq™ Hot Start Version GMP grade” which will be released in the world in January 29, 2016.

 

Recent studies have identified pathology and mechanism of diseases at genetic level and have clarified that efficacy oftherapeutic agents, adverse reactions, and pathology vary by genetic individual differences. In order to provide optimal care tailored to the individual patient, importance of genetic analysis has increased, and prompt development of genetic diagnostic agents andgenetic diagnosis methods has been required. There is a gene amplification process in the genetic analysis. In the process, PCR enzyme that allows gene amplification is used.

 

The PCR enzyme has been manufactured in the facility in Kusatsu city, Shiga prefecture, Japan, in compliance with GMP which is the standards for manufacturing control and quality control of products such as pharmaceutical anddiagnostic agents. The PCR enzyme ensures high quality standards which are essential for diagnostic agents and clinical laboratory tests. The product has been supplied to companies for diagnostic agents and/or laboratory tests. Furthermore, Takara Bio provides customized services, including changes in concentration and/or contents, in response to various customers’ needs.

 

Takara Bio will continuously focus on development of GMP grade products for line-up expansion and aim to increase sales in the expanding business support industry.