Congress just gave the FDA a meaningful directive that would help replace the use of horseshoe crab blood in pharmaceutical testing, strengthening the medical supply chain and patient safety, while ...
Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety. Endotoxins are small, hydrophobic molecules that are part ...
Lonza has announced an expansion to its PyroTec® PRO Automated Robotic Solution for endotoxin testing. The new PyroWave® Reader add-on has been designed specifically for use with the sustainable ...
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss ...
Endotoxin testing is critical for quality control in drug production, as it has a direct impact on pharmaceutical safety and effectiveness. Traditionally Limulus Amebocyte Lysate (LAL) testing is used ...
Quote from Orla Cloak, Director of Testing and Informatics Solutions, Lonza BioScience: “This new addition to our established PyroTec® PRO Solution provides laboratories with greater ability to reduce ...
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.
STEMart now offers Rapid Endotoxin Testing services for the rapid quantitative analysis of endotoxins to help manufacturers make fast, reliable decisions about the safety of medical devices. The ...
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 ...