Since 2013, low endotoxin recovery (LER) has been a hot topic within the industry. Failure to detect spiked endotoxin in some finished sterile biologics despite testing with the Limulus amebocyte lysate (LAL) assay has proved alarming across industry and with regulators.
PDA is excited to announce the release of Technical Report No. 82: Low Endotoxin Recovery. The task force spent innumerable hours working on this document and hopes it helps biologics manufacturers address this potential concern in their processes. Not only does the technical report offer steps to address the problem but it also includes 12 case studies conducted by biologics manufacturers.
In addition to TR-82, PDA will release a compilation book containing chapters relating to endotoxin testing, including LER. These have been pulled from articles designated as highly relevant from the PDA Journal of Pharmaceutical Science and Technology.
Both the technical report and the book will be available in the PDA Bookstore. PDA members also have 30 days to download a free copy of the technical report.