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
June 25, 2020
Richmond, Virginia – 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, 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.
For more information about FUJIFILM Wako Chemicals U.S.A. visit https://www.wakopyrostar.com/
FUJIFILM Wako Chemicals U.S.A. Corporation is recognized around the world as a trusted supplier of high purity chemicals and reagents to service the Specialty Chemicals, Laboratory Chemicals and Diagnostics business sectors. In 1989, the company relocated sales operations from Dallas, TX and established both their corporate headquarters and manufacturing facility in Richmond, VA. Today, FUJIFILM Wako continues the development of products dedicated to the health, welfare and safety of our customers, as well as, the protection of our environment.
FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com
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 According to Regulatory Affairs Professional Society (RAPS), 32 COVID-19 vaccine candidates currently in clinical trials (as of June 18)