FUJIFILM Wako Introduces Line of Endotoxin Detection Reagents to U.S. Market
PYROSTAR™ ES-F line for endotoxin detection poised to support quality assurance process of future COVID-19 vaccine manufacturing
Richmond, Virginia, June 25, 2020 – FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako), a wholly owned subsidiary of FUJIFILM Wako Pure Chemical Corporation of Japan, announced the U.S. introduction of the PYROSTAR™ ES-F line of limulus amebocyte lysate (LAL) reagents, which are engineered to detect the presence of bacterial endotoxins.
The detection of endotoxins is required in a number of industries, including medical device and vaccine manufacturing, to minimize bacterial contamination in final product. As vaccine manufacturing is expected to increase due to COVID-19[1], bacterial endotoxin testing will be a crucial quality assurance measure to ensure patient safety.
Unlike traditional LAL reagents that are untreated and can lead to false-positives by activating 1,3)-ß-D-glucan, PYROSTAR™ ES-F is designed for the specific determination of gram-negative bacterial endotoxins, while also remaining unreactive to (1,3)-ß-D-glucan. Additionally, PYROSTAR™ ES-F is dual-purpose and can perform as either a quantitative turbidimetric (KTA) or qualitative gel- clot test assay. Available in both a single-test or multi-test configuration, the PYROSTAR™ ES-F line of reagents fits a wide range of quality control needs in environments where medical devices and vaccines are manufactured.
“As the demand grows for vaccines especially in the wake of COVID-19, FUJIFILM Wako understands the need for accurate and dependable bacterial endotoxin testing to ensure vaccines are not contaminated with harmful bacteria,” said Lisa Komski, General Manager LAL Sales,, FUJIFILM Wako Chemicals U.S.A. Corporation. “Mitigating risk to patients and complying with regulatory standards is vital. Endotoxin testing helps pharmaceutical companies avoid releasing defective products to the market. More importantly, it protects vulnerable patients.”
FUJIFILM Wako will distribute the PYROSTAR™ ES-F reagents under their Limulus Amebocyte Lysate (LAL) Division in the U.S.
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