Otsu/Shiga, Japan – June 17, 2015 -  Takara Bio Inc. announced that on June 16, 2015, it acquired ISO 9001 certification, an international standard for quality management system, for the CDM center – a base for the manufacturing and development of regenerative medicines, biopharmaceuticals, and related products and services.

 

In an effort to improve quality of Takara Bio’s products and services, Kusatsu office was registered as a clinical laboratory in October 2014 and has been performing hematological tests and pathological tests according to regulatory standards. And also, Takara Bio’s acquisition of accreditation of “foreign cell processor” to conduct specific processed cell manufacturing in May 2015 has enabled it to provide medical institutions with contracted cell processing services, at a high level quality.

 

Takara Bio further improves its system and provides high-quality products and services in regenerative medicine fields. Takara Bio is committed to further improvement of its quality products and services.

【Accreditation】

Standard

JIS Q 9001 : 2008 (ISO 9001 : 2008)
Organization registered

Takara Bio Inc., the CDM center of head office, the CDM center at Kusatsu office

Scope registered

[1] The CDM center, head office

  • Design, development, manufacturing and provision of raw materials for  medicinal products under Takara Bio’s brand

[2] The CDM center, Kusatsu office

  • Design, development, manufacturing and provision of raw materials for medicinal products under Takara Bio’s brand
  • Design, development and provision of contracted manufacturing service of investigational new drugs and materials for medicinal products
  • Design, development and provision of testing service for medicinal products, investigational new drugs and raw materials for medicinal products
  • Design, development and provision of storage service for cells and other materials
Date of registration June 16, 2015
Accreditation no. JMAQA-2577
Authority Japan Management Association Quality Assurance Registration Center