FUJIFILM Wako Pure Chemical Launches GMP-compliant 
ROCK Inhibitor Y-27632 for Industrial Applications

OSAKA, Japan – May 11, 2023 – FUJIFILM Wako Pure Chemical Corporation (President: Koichi Yoshida) is pleased to announce the launch of its Good Manufacturing Practice （GMP）-compliant ROCK inhibitor¹ “Y-27632 for industrial cell culture applications. Y-27632 offered by FUJIFILM Wako Pure Chemical Corporation is compliant with the 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). 

For about 10 years, FUJIFILM Wako Pure Chemical Corporation has been manufacturing and distributing “CultureSure®” Y-27632 as research-use-only reagent designed for hiPSC culture and will now offer GMP-compliant “Y-27632” for commercial-use as of May 25th.

With their capacity for limitless expansion and differentiation potential, hiPSCs offer numerous clinical and biomedical applications, including the development and commercialization of cell therapies.  hiPSCs are highly susceptible to apoptosis during cell dispersion;³ life science reagents, such as Y-27632, that can promote survival of hiPSCs, are required to accelerate cell therapy development. Y-27632, effective and selective ROCK inhibitor, was first shown to have beneficial effects on human embryonic stem cell survival, differentiation potential, and differentiation capabilities in a landmark study published in 2007.⁴ Subsequent work has shown its utility in the recovery and passage of hiPSCs,⁵  and media supplementation with Y-27632 has since become standard practice in the field.

“As part of our mission and commitment to the future of science, we are pleased to offer GMP-compliant Y-27632 for utilization in commercial manufacturing of cell therapy products, a burgeoning treatment modality for cancers, autoimmune diseases, infectious diseases, among others,” said Kuniaki Okamoto, Ph.D., , Executive Officer, R&D Marketing Operations, Laboratory and Specialty Chemicals Division. “At FUJIFILM Wako Pure Chemical Corporation, we will continue to develop and deliver advanced, high-quality products that meet the needs of our customers and society, contributing to the development of a wide range of fields such as pharmaceutical and cell therapy.”

Y-27632 for commercial use is synthesized at the Miyazaki Plant of FUJIFILM Wako Chemical Corporation in Miyazaki, Japan, and is compliant with ICH-Q7 GMP for active pharmaceutical ingredients.

1. 1:Rho kinase (Rho-associated, coiled-coil containing protein kinase) inhibitor. Rho kinase is a cytoplasmic phosphoenzyme involved in various biological functions including cell proliferation, cell adhesion and vasoconstriction.
2. 2:GMP guideline for active pharmaceutical ingredients, adopted under the agreement of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and notified to Japan in 2001.
3. 3:One of the processes in cell culture involving transfer of cells to another cell culture dish to promote new cell aggregation.
4. 4:Watanabe K, Ueno M, Kamiya D, Nishiyama A, Matsumura M, Wataya T, Takahashi J, Nishikawa S, Nishikawa S, Muguruma K and Sasai Y 2007. A ROCK inhibitor permits survival of dissociated human embryonic stem cells. Nat Biotechnol 25(6):681-6, PMID: 17529971, https://doi.org/10.1038/nbt1310.
5. 5:Castro-Viñuelas R, Sanjurjo-Rodríguez C, Piñeiro-Ramil M, Rodríguez-Fernández S, López-Baltar I, et al. 2021. Tips and tricks for successfully culturing and adapting human induced pluripotent stem cells. Mol Ther Methods Clin Dev 23:569-581, PMID: 34901305, https://doi.org/10.1016/j.omtm.2021.10.013.