Thermo Fisher Scientific in Japan is pleased to announce that, as of 22 April 2024, Takara Bio Inc. has begun large-scale viral vector contract manufacturing with the newly installed Thermo Scientific^TM DynaDrive^TM Single-Use Bioreactor.

As a contract development and manufacturing organization (CDMO) in the fields of regenerative medicine, cell therapy, and gene therapy, Takara Bio provides one-stop services for the development, manufacturing, and quality testing of gene therapy drugs to pharmaceutical companies and bio ventures in Japan and overseas. The Center for Gene and Cell Processing (CGCP), which is the hub facility of the CDMO business, conducts gene therapy research and pharmaceutical commercial production in compliance with GMP (Good Manufacturing Practice for manufacturing and quality control of pharmaceuticals and quasi-drugs). This includes contract manufacturing services for various virus vectors, such as adenovirus vectors. With the recent installation of the DynaDrive bioreactors in 50 L, 500 L, and 3,000 L capacities, the company is now capable of performing process development to manufacturing for fermentation.

The single-use bioreactor cell culture vessels are available in four sizes: 50 L, 500 L, 3,000 L, and 5,000 L. The rectangular design and its unique blade impellers provide both gentle stirring that minimizes stress on the cells and high stirring efficiency that is suitable for culturing cells with high oxygen consumptions.

Thermo Fisher and Takara Bio have collaborated since the early stages of the viral vector process development, verifying the use of high-performance equipment and establishing cell culture methods. As a result, the two companies will have the ability to meet the recent increase in market needs for viral vectors, covering wide-ranging needs from clinical trial products to commercial production.

Takara Bio will leverage the product to launch large scale contract manufacturing of viral vectors, enabling them to proceed with a one-stop solution from viral vector process development to manufacturing in GMP facilities. Overall, this will broadly and firmly support the development and manufacturing of gene and cell therapy pharmaceuticals.

Thermo Fisher is committed to assisting its customers in achieving their goals by providing expert support to help them get the most out of the products.