LER is defined as the failure to detect a known amount of spiked endotoxin in an undiluted drug product over multiple time points. Since its discovery in 2013, LER continues to be a topic of debate and a complex challenge for the endotoxin testing community.

Lonza’s LER White Paper, available for download in the QC Insider™ Toolbox, provides the latest understanding of the LER phenomenon. Topics include:

• The impact of LER on pharmaceutical manufacturing
• Update on guidance from regulatory authorities
• How to manage LER in your daily work

Download the White Paper: LER: Beyond the Controversy