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17th July 2023  Content supplied by: FUJIFILM Wako Chemicals U.S.A. Corporation

A Sustainable Alternative for Endotoxin Testing

PYROSTAR™ Neo is a 3-factor recombinant, 100% animal free, fully synthetic Limulus Amebocyte Lysate (LAL) alternative. The 3-factor system mimics the same cascade reaction as traditional LAL, with three recombinant factors (Factor C, Factor B, and proclotting enzyme) and the pNA chromogenic group. This assay closely mimics the action of natural LAL, ensuring no difference in endotoxin measurement between natural LAL and this synthetic alternative. The synthetic reagent is also naturally endotoxin-specific and will not react to (1-->3) ß-D-Glucans.

The reagent uses a colorimetric method that can be used with any standard kinetic, incubating, absorbance plate reader at 405 nm. There is no need for a specialized fluorescent reader in measurement. The assay is highly sensitive and precise with a lower quantitative sensitivity limit of 0.001 EU/mL. The quantitative range is the highest of any synthetic alternative to LAL, providing a standard curve from 50 to 0.001 EU/mL with high correlation values and low variability.

PYROSTAR™ Neo also offers stable storage not seen with any other synthetic LAL alternative on the market. After reconstitution, the reagent is stable for 4 hours at 2-8°C. If storage for another day of testing is needed, it can be stored for up to 14 days at -30°C. Overall, this endotoxin detection reagent provides a reliable and accurate solution for production and end-process endotoxin detection for pharmaceuticals and medical devices.

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Date Published: 17th July 2023

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FUJIFILM Wako Chemicals U.S.A. Corporation


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