Cologne, Germany / Basel, Switzerland, 07 March 2017 – Today Lonza announced the release of a new tool in the QC Insider™ Toolbox that provides the latest information on low endotoxin recovery (LER), a continued topic of debate and a complex challenge for the endotoxin testing community. A new white paper, “Low Endotoxin Recovery: Beyond the Controversy,” has been added to the QC Insider™ Toolbox.
The new tool gives details about the latest understanding of this phenomenon, together with an update on guidance provided by regulatory authorities. This educational document aims to keep QC professionals abreast of developments in this important field and provides recommendations on how they can better manage LER in their daily work.
LER is defined as the failure to detect a known amount of spiked endotoxin in an undiluted drug product over multiple time points. It has been linked to the use of polysorbate in conjunction with a chelating buffer although the exact mechanism remains unclear. Since its discovery in 2013, LER and its management have been topics of much debate.
Katrin Hoeck, Head of Marketing Analysis and Testing at Lonza BioScience, explains: “Endotoxin testing is a vital element of the manufacturing of parenteral pharmaceuticals and medical devices – and without it there would be a significant risk to patient health. Our new LER white paper addresses the current understanding of LER, its potential impact on pharmaceutical manufacturing, approaches to tackling LER and the latest guidance from the FDA, all important considerations for the end user.”
Launched in 2015 the QC Insider™ Toolbox is a suite of online, comprehensive tools designed to support QC professionals performing the bacterial endotoxins test (BET). Subscription is required to access the QC Insider™ Toolbox and is free.
More information is available by visiting: www.lonza.com/qcinsider