Endotoxins Standards and Their Role in Recovery Studies: The Path Forward
Information from the USP Microbiology Expert Committee studying endotoxin contamination suggest that broadening analytical options to include a well-defined native CSE calibrated against the RSE is not only a good scientific option, but is also an extremely pragmatic one. Read their perspective in the latest BioPharma Asia article.
The LAL Industry's Invaluable Partner
In modern history, endotoxin testing has improved the safety of drugs and medical devices around the world, and the horseshoe crab has been a vital part of that improvement. John Dubczak, General Manager of Charles River's Microbial Solutions Division, discusses in Outsourced Pharma.
Screening Successfully for Endotoxins
Variability in conventional LAL reagents highlights the need for a testing method that does not require endotoxin curves. One such method is the Endosafe® Portable Test System™ (PTS), which utilizes a kinetic chromogenic technique and an archived standard curve.
Isolate, Identify and Validate with Charles River Microbial Solutions
Foster Jordan, Corporate Senior Vice President at Charles River, recently spoke with rapidmicrobiology.com regarding the Accugenix® Microbial ID and Strain Typing service.
The Great LER Debate
Low endotoxin recovery (LER) has been a topic of interest for almost three years, but not much changed in that time. John Dubczak, General Manager of Charles River Microbial Solutions, discusses in Outsourced Pharma.