June 27, 2024

Fuji Film Wako Pure Chemical Industries, Ltd. (Headquarters: Chuo-ku, Osaka; President: Koichi Yoshida) will release reagent kits for the MAT method to detect pyrogen (LumiMAT Pyrogen Detection Kit, hereinafter referred to as LumiMAT) and endotoxin measuring reagents that do not contain animal-derived components (PYROSTAR Neo +) on July 1, 2024, as an alternative to animal experiments for in vitro methods.¹The MAT method is used to detect fever-inducing substances in vitro. It is necessary to use animals for experiments to ensure safety and effectiveness in the development and manufacturing of pharmaceuticals and medical devices. The fever-inducing substance test is a test that detects fever-inducing substances that can cause biological reactions such as fever, shock, and in the worst case death when they invade human blood. It is essential to confirm the safety of non-oral pharmaceuticals and medical devices that come into contact with blood, such as syringes and catheters. Fever-inducing substances are divided into endotoxin and non-endotoxin fever-inducing substances. LAL reagents, which use horseshoe crab blood as a material, are used to detect endotoxins, and the rabbit fever-inducing substance test is mainly used to confirm the safety of medical devices that come into contact with blood when non-endotoxin fever-inducing substances are suspected. These test methods are included in the pharmacopeia of Japan, Europe, the United States, etc., but in recent years, there has been a movement to switch to alternative methods that do not depend on animals due to ethical concerns regarding the use of experimental animals and the increasing interest in biological diversity conservation.²We will release the LumiMAT reagent kit for the MAT method, which was developed as an alternative to the rabbit fever-inducing substance test for in vitro methods by our company. In Europe, the rabbit fever-inducing substance test is scheduled to be removed from the European Pharmacopoeia by 2026, and there is an expected similar movement in other regions in the future, which has spurred the consideration of switching to the MAT method. Many of the reagents currently available for the MAT method use PBMC (peripheral blood mononuclear cells) derived from blood, and measure cytokines released by monocyte-derived cells due to exposure to fever-inducing substances by the ELISA method to detect fever-inducing substances in the sample. This method has the challenges of the difference between PBMC lots and the long assay time. Furthermore, there is a concern about the stability of the source since human blood is used as raw material. On the other hand, the LumiMAT that we have developed screens multiple types of cell strains and adopts the human NOMO-1 cell, which has superior sensitivity to fever-inducing substances. By cultivating and proliferating cell strains to manufacture them, the lot-to-lot difference of the reagent becomes small, and more reliable test results can be obtained, and the stability of the source is increased, making stable supply possible. In addition, the luciferase reporter assay method for detecting the activation of the transcription factor NF-kB9 is adopted for the measurement method, making it possible to obtain quick and simple results. It takes about 1.5 days to obtain results with conventional MAT reagents, whereas LumiMAT can measure in about 5 hours.

PYROSTAR Neo+, a genetically engineered endotoxin measuring reagent that we will release at the same time, is an artificial creation of three factors (C factor, B factor, and coagulation enzyme precursor) that constitute the endotoxin reaction mechanism of horseshoe crabs as recombinant proteins, and is compatible with the chromogenic synthetic substrate method, which can measure the amount of endotoxins with high accuracy. It retains the high sensitivity and excellent stability after dissolution of PYROSTAR Neo, which was released in December 2021, reduces interference reactions caused by some drugs, improves reactivity to natural endotoxins, and expands the application to a wide range of samples. It is compatible with universal endotoxin measuring devices and can be used not only for safety evaluation of pharmaceuticals and medical devices in the approval application but also for quality control purposes such as raw material inspection and water quality management for pharmaceutical manufacturing.³⁴

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Through the development and sales of these products, we will also respond to the testing needs of fever-causing substances that do not depend on animals. Under the mission of becoming "the power of the next science and creating the source of people's happiness", we will continue to develop and provide high-functionality and high-quality products that respond to the needs of society and customers, contributing to the development of a wide range of industries and academic research, including medical care.

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