Our core manufacturing facility, the Center for Gene and Cell Processing (CGCP) located in West Japan, was designed specifically for the safe and efficient manufacture of cellular and gene therapy products. In 2016, the International Society for Pharmaceutical Engineering selected Takara Bio’s CGCP as the winner of its Facility of the Year Award (in the facility integration category). Its unique environment ensures product safety and was determined by the judges to be a practical, efficient model for future biopharmaceutical facilities.
Meets major GMP regulations
The CGCP was designed to meet major regulations like cGMP, PIC/s GMP, and EU GMP. It has received accreditation as a “foreign cell processor” to conduct specific processed-cell manufacturing. It has also received ISO 9001 certification.
One-stop manufacturing facility
The CGCP is an integrated facility, housing three independent areas for plasmid DNA (and recombinant protein), virus, and cell processing. Each area has an independent airflow pipeline, material flow, VHP (vaporized hydrogen system) for decontamination, and personnel team. They are also equipped with independent QC laboratories and dedicated facilities for cell banking. Since the independent processing areas are all under one roof, the CGCP can operate with high efficiency and zero contamination, so you can depend on the products produced and services performed on-site.