News

Shimadzu Corporation has signed an investment contract with U-Medico Inc, (head office: Osaka prefecture; hereinafter U-Medico), a contract research organization (CRO). In accordance with this investment, from December 2024, Shimadzu has collaboratively developed a gene therapy pharmaceuticals manufacturing platform aimed at pharmaceutical companies, contract development and manufacturing organizations (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.

Gene therapy is a therapeutic method in which administration of a virus vector, a virus containing therapeutic genes, leads to gene normalization. Implementation of this approach is progressing as a therapeutic method for rare diseases that are caused by genetic abnormalities. Applications are also expected for other ailments, so the market for gene therapy pharmaceuticals is forecast to grow by more than 20 % annually. Once they have been administered, gene therapy pharmaceuticals can treat the genes themselves, and there are many cases in which repeated administrations are not needed. Although the scale of manufacturing is smaller than for preceding biomedical supplies, it requires high-level manufacturing and quality control techniques. Also, analytical and evaluative methods for cell cultivation, impurity removal, purification, and evaluation of the completed drug substance, which are processes in the manufacturing of the virus vectors required for gene therapy pharmaceuticals, are not sufficiently established at present. Accordingly, the stable manufacturing of high quality gene therapy pharmaceuticals is still a significant issue.

U-Medico is a startup from Osaka University. The company develops CRO projects specific to biomedical supplies including antibody medicines and gene therapy pharmaceuticals. Professor Susumu Uchiyama of the Graduate School of Engineering, Osaka University, the founder of U-Medico, is a world leader in research and applications utilizing ultracentrifuge analysis and the mass spectrometry of protein complexes, based on the physics and chemistry of biopolymer solutions. U-Medico will utilize these techniques to offer a variety of analytical services. Additionally, U-Medico has a wealth of technology and knowledge related to the evaluation of the physical and chemical properties of biomedical supplies. They have had a number of achievements to date primarily involving antibody medicine quality analysis and formulation development. In recent years, they have offered services for developing virus vector manufacturing process, and in 2025, are expected to start offering quality analysis services in conformity with GMP. Since 2023, Shimadzu has been pursuing research related to controlling the manufacturing quality of gene therapy pharmaceuticals at the Osaka University and Shimadzu Analytical Innovation Research Laboratories.

Based on analytical and evaluative techniques developed by the Uchiyama Laboratory and U-Medico, 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. We are also developing instruments and software by optimizing Shimadzu liquid chromatograph mass spectrometers (LC-MS), CellTune software supporting the optimization 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.

Shimadzu aims to develop end-to-end solutions for biomedical supplies, as drug manufacturing is positioned as an important segment in our medium-term management plan. Since November of this year, Shimadzu has pursued the release of products used in the biomedical supply manufacturing process, in cooperation with Sepragen, a company in the USA that deals with purified chromatography projects. Shimadzu Diagnostics Corporation, a manufacturing and sales subsidiary involved in clinical projects in the Shimadzu Group, is deploying projects for the development and marketing of culture media for cell cultures customized on a customer by customer basis. The Shimadzu Group as a whole will continue the rapid societal implementation of products and technologies aimed at biomedical supplies, thereby contributing to the swift development and stable manufacture of biomedical supplies.

Overview of U-Medico

U-Medico Inc.