FUJIFILM Toyama Chemical Obtain GLP Certificate for Drug Testing with Measurement of Extracellular Field Potential (MEA method) using iPS Cell-Derived Cardiomyocyte

Tokyo, July 24, 2025 – FUJIFILM Toyama Chemical Co., Ltd. (President: Mitsuhiro Sato) today announced that it has obtained Good Laboratory Practice (GLP)^*1 certificate in the category of in vitro toxicity testing for its Toyama Research and Development Center, which serves as a Contract Research Organization (CRO) providing drug discovery support services. The certificate applies to studies involving "Evaluation of Extracellular Field Potential (MEA method) utilizing Human iPS Cell-Derived Cardiomyocytes." With this certificate, FUJIFILM Toyama Chemical offer GLP-compliant contract testing services for this method, effective immediately.

Safety pharmacology studies play a critical role in evaluating the effects of drugs on vital organ systems essential for sustaining life. These studies are conducted in GLP-compliant facilities based on international guidelines (ICH S7A). Among these assessments, cardiovascular safety pharmacology requires the use of in vitro tests^*2. However, the conventional systems focus solely on analyzing the function of specific proteins involved in cardiac electrical signaling, which makes it challenging to accurately predict outcomes during later clinical stages. In contrast, iPS cell-derived cardiomyocytes not only express specific proteins but also exhibit a broader range of proteins involved in multiple electrical signals, like those found in living organisms. As a result, the MEA method, which utilizes iPS cell-derived cardiomyocytes, shows potential in detecting QT interval prolongation^*3 and life-threatening proarrhythmia with greater accuracy. This technology is gaining attention as a system that could either complement or potentially replace conventional safety pharmacology tests.

With the certificate of GLP for drugs compliance, FUJIFILM Toyama Chemical will expand its CRO services by utilizing iPS cell-derived differentiated cells, which reproduce human physiological responses to deliver precise evaluation and analysis. The company sets to launch GLP-compliant contract testing services employing the MEA method with iPS cell-derived cardiomyocytes. Building on its extensive expertise in drug discovery, FUJIFILM Toyama Chemical aims to provide comprehensive, integrated services that cover the entire spectrum from drug discovery research to pharmaceutical development and contract manufacturing (CDMO). Additionally, the company will continue collaborating with the Bio Science & Engineering Laboratories^*4 of FUJIFILM Corporation to develop and introduce cutting-edge pharmacological testing technologies and remain at the forefront of innovation.

FUJIFILM Toyama Chemical plays a pivotal role in the Fujifilm Group’s drug discovery support CRO business. By leveraging its strong research foundation, built over decades of pharmaceutical development, and cutting-edge evaluation systems incorporating technologies such as iPS cells, the company provides drug discovery support services that offer exceptional value and high reliability. Through these efforts, FUJIFILM Toyama Chemical strives to drive innovation and contribute to the further advancement of the pharmaceutical industry.

• *1 Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs
• *2 Known as the hERG assay, this safety pharmacology test evaluates the inhibitory effects on potassium channels involved in cardiac activity.
• *3 Refers to the interval measured from the start of the QRS complex to the end of the T-wave, representing the time from ventricular depolarization to subsequent repolarization.
• *4 The Bio Science & Engineering Laboratories participate in the Consortium for Safety Assessment using Human iPS Cells (CSAHi) and contribute to the establishment of international standards for measurement of extracellular field potential (MEA method) utilizing iPS-derived cardiomyocytes.

FUJIFILM Toyama Chemical, one of the core companies in the Fujifilm Group's healthcare segment, is committed to solving social issues through its pharmaceutical business. Leveraging over 40 years of expertise in anti-infective drugs, the company focuses on contract manufacturing as it is the only company capable of synthesizing penicillin antibiotics and manufacturing sterile formulations in Japan. In 2020, the company expanded its capabilities by introducing Contract Development & Manufacturing Organization (CDMO) services for liposomes and lipid nanoparticles. Through its parent company FUJIFILM Corporation, which holds patents on ionized lipids – a critical component of lipid nanoparticles, FUJIFILM Toyama Chemical is able to deliver proprietary lipids that have already been used as investigational drugs. Further expanding its portfolio, the company began offering contract manufacturing services for non-clinical mRNA applications in 2023, with plans to extend these services to clinical trial and commercial production. Additionally, by 2027, the company aims to launch CDMO services for antibody drugs and Antibody-Drug Conjugates (ADCs). For more information about FUJIFILM Toyama Chemical, visit: https://www.fujifilm.com/fftc/en

The Fujifilm Group leverages its advanced AI technologies and biotechnological expertise, cultivated through a diverse range of business fields, to provide drug discovery support CRO services to pharmaceutical companies and biotech ventures. These services span the discovery of new drug candidates and the evaluation of their efficacy and safety. Our offerings include evaluation services utilizing products from FUJIFILM Cellular Dynamics, Inc., a leading company in the iPS cell technology, as well as our proprietary human iPS cell-derived intestinal epithelial cells. Additionally, we offer specialized peptide discovery services using mRNA display technology. Through these advanced and comprehensive solutions, the Fujifilm Group offers full-scale support for drug discovery research. Under our tagline "Partners for Life," Fujifilm is committed to being a true partner to pharmaceutical companies and patients, contributing to the advancement of the pharmaceutical industry. For more details, please visit: https://global.fujifilm.com/en/healthcare-life-sciences/cro

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