This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices. The potentially devastating effects of ...
Endotoxin refers to a component of the outer cell membrane of Gram-negative bacteria called lipopolysaccharide (LPS). LPS is the biologically active portion of naturally occurring endotoxin complexes.
In this episode of C&EN Uncovered, host Craig Bettenhausen speaks with C&EN assistant editor Laurel Oldach about the use of horseshoe crab blood in pharmaceutical endotoxin testing, the challenges of ...
AGAWAM, Mass., Oct. 24, 2012 /PRNewswire/ -- A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration's (FDA) ...
The ICH is a regional harmonization group composed of the US, EU and Japan, with other countries, such as Canada, participating in a voluntary capacity. The aim of the group is to allow the regulatory ...
The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins ...
Predictive Oncology logo · GlobeNewswire Inc. RICHMOND, VA, and PITTSBURGH, April 25, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Wako Chemicals U.S.A. Corporation (Fujifilm), a supplier of high purity ...
As thoroughly covered in your recent article (C&EN, Oct. 28, 2024, page 26), the issue of replacing the traditional natural product test for endotoxin, limulus amoebocyte lysate (LAL), with a ...
Lonza announces the release of a new FAQ Tech Tip, “Data Integrity for Endotoxin Testing” for its QC Insider™ Toolbox. Since data integrity is a fundamental component of the pharmaceutical industry, ...
GMP/GLP compliant testing laboratory, Wickham Laboratories Ltd, offers a dedicated in vitro bacterial endotoxin service for clients requiring biocompatibility testing. Wickham Laboratories offers ...