Japan's Shimadzu develops platform to support gene therapy manufacturing

Japan-based Shimadzu Corporation has signed an investment contract with U-Medico Inc, a contract research organisation (CRO). In accordance with this investment, Shimadzu has collaboratively developed a gene therapy pharmaceuticals manufacturing platform aimed at pharmaceutical companies, contract development and manufacturing organisations (CDMO), and educational & research institutions, and has begun offering this platform in Japan and overseas. This is the first full-scale participation by Shimadzu in a manufacturing support project for gene therapy pharmaceuticals.

Shimadzu and U-Medico are cooperatively establishing analytical and evaluative methods for gene therapy pharmaceutical manufacturing processes, in order to enable the stable manufacturing of high-quality gene therapy pharmaceuticals.

The companies are also developing instruments and software by optimising Shimadzu liquid chromatograph mass spectrometers (LC-MS), CellTune software supporting the optimisation of cell culture conditions and other instruments for use in gene therapy pharmaceutical manufacturing processes. Shimadzu will also market a gene therapy pharmaceuticals manufacturing platform integrating these elements, and a custom culture media manufactured using CellTune. Custom culture media will also be offered to U-Medico, with Shimadzu aiming to expand recurring business. Using these, U-Medico will provide high quality virus vector manufacturing support services for drug manufacturing and CDMO.