If you have attended any conferences about endotoxin testing these past years, chances are you heard a talk about Low Endotoxin Recovery (LER). LER has been a hot, and hotly-contested, topic since it was first presented by Cheng et al. in 2013. In March, the Parenteral Drug Association (PDA) published its Technical Report 82 to help companies with their LER studies.
Most importantly, the report provides guidance on developing robust and scientifically sound LER hold-time studies. While it is not a “cookbook”, it details points like endotoxin source, spiking, storage time/container/temperature, as well as data analysis and interpretation. For those who encounter LER in these studies, the PDA report outlines a number of mitigation strategies, like the addition of dispersants and other sample treatments, or the switch from bacterial endotoxin testing to a biological system.
Other sections are dedicated to the proposed mechanism of LER, the history of LER studies, as well as the definition of terms that have been used somewhat interchangeably in the past. Of special interest for people tasked with looking into LER might also be the appendix – it comprises 12 case studies, and with 80 pages makes up the bulk of the report.
Technical Report 82 is available on the PDA website.
Written by Saskia
Scientific Support Specialist, Lonza Pharma-Bioscience Solutions at Lonza