FUJIFILM Wako Pure Chemical Launches GMP-compliant 
GSK-3β Inhibitor CHIR99021 for Industrial Applications of iPS cells

OSAKA, Japan – January 19, 2026 - FUJIFILM Wako Pure Chemical Corporation (President: Koichi Yoshida) is pleased to announce the launch of its Good Manufacturing Practices (GMP) -compliant GSK-3β (glycogen synthase kinase 3 beta)  inhibitor^*1 “CHIR99021” for industrial cell culture applications. FUJIFILM Wako Pure Chemical Corporation’s “CHIR99021” is compliant with ICH-Q7 GMP for active pharmaceutical ingredients^*2, and is designed for commercial manufacture of cell therapy products using human induced pluripotent stem cells (hiPSCs).

Research and development of cell therapy products using hiPSCs has progressed rapidly in recent years. However, one of the critical challenges in transitioning from the research phase to commercial production is minimizing the variability inherent in hiPS cell culture, which can result from intrinsic cell line differences, culture conditions, and operational and scale-up dependent issues. Since culture supplements play a crucial role in maintaining hiPSC quality, it is essential that these supplements meet strict quality standards as raw materials to ensure reliable and stable production of cell therapy products.

“CHIR99021” is a selective inhibitor of GSK-3β that activates the canonical Wnt signaling pathway^*3 by preventing the phosphorylation and subsequent degradation of β-catenin. Consequently, it promotes cell proliferation and differentiation processes regulated by Wnt signaling. Following the launch of the ROCK inhibitor “Y-27632” in 2023 and the ALK4, 5, and 7 inhibitor “SB431542” in 2025, CHIR99021” is introduced as the third ICH-Q7-compliant culture supplement product for cell therapy applications.

All these products are manufactured at the facilities equipped with GMP-compliant equipment. Also, they undergo rigorous testing based on the Japanese Pharmacopoeia, including viable count testing, bacterial endotoxins testing, and mycoplasma testing. These measures minimize the risk of contamination by microorganisms and related components in cell therapy products, thereby ensuring the safety and quality required for commercial production. Furthermore, the company is committed to carefully listening to the customers’ requests and offering customized products tailored to meet their specific needs.

Under the mission of “With commitment to the future of science, our company is dedicated to create the source of happiness for all people,” FUJIFILM Wako Pure Chemical will continue to provide highly functional and high-quality products that meet the needs of customers and contribute to the development of industry and academic research in a wide range of fields.

• ※1    ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) is an international conference in which representatives from pharmaceutical regulatory authorities and the pharmaceutical industry collaborate to develop guidelines on pharmaceutical regulations from scientific and technical perspectives. Among these guidelines, ICH-Q7 (GMP for Active Pharmaceutical Ingredients) specifies the standard practices for the manufacturing and quality control of active pharmaceutical ingredients.
• ※2 GSK-3β (glycogen synthase kinase 3 beta) is an enzyme that phosphorylates various proteins inside the cell. A GSK-3β inhibitor refers to a compound that inhibits the activity of this enzyme.
• ※3    Wnt Signaling Pathway is a crucial communication route that regulates cell proliferation and differentiation, playing a key role in modulating cell properties and functions in regenerative medicine and stem cell research.

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