Today Lonza announced a new resource available in the QC Insider™ Toolbox that addresses a key topic of debate in the endotoxin detection community – Low Endotoxin Recovery (LER). Building on Lonza’s comprehensive suite of support tools, a “Low Endotoxin Recovery (LER) - Frequently Asked Questions” Technical Tip sheet has been added to the QC Insider™ Toolbox.
This new tool, in addition to an archived webinar available for viewing, “Low Endotoxin Recovery (LER) – Context and Resolution from a Broad Biologics Test Perspective,” delivers the latest information about this phenomenon and guidance on how QC professionals can better manage LER in their daily work.
LER has been defined as the masking of endotoxin in undiluted biological drug products, such as monoclonal antibodies, vaccines and other protein products, and has been linked to the use of polysorbate in conjunction with a chelating buffer – specifically citrate and phosphate buffers. Lonza’s support tools provide QC professionals with details on how to recognize LER in a process/product and what the LAL community is doing to help drug manufacturers who experience LER.
Katrin Hoeck, Head of Marketing Analysis and Testing at Lonza Bioscience Solutions, explained: “Every biologic drug seeking approval for marketing in the United States requires filing of a Biologic License Application (BLA). These LER resources in our QC Insider™ Toolbox – including the new Tech Tip sheet – not only provide guidance for the end user on the FDA’s current position on LER, but also include recommendations for performing hold-time studies and information on the use of naturally occurring endotoxin (NOE).”
The QC Insider™ Toolbox, initially launched in 2015, is an internet portal designed to provide expert online support for QC professionals responsible for endotoxin testing. Accessible online at anytime and anywhere, it offers comprehensive support tools, training resources and a library of information that will help QC professionals achieve success in bacterial endotoxins testing.