Walkersville, MD (USA) / Cologne (DE), 14 September 2016 – 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.
More information is available by visiting: www.lonza.com/qcinsider.
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B3 compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found at www.lonza.com.
