From Bench to Reality: the Role of Natural Contaminations in LER Investigations
There is ongoing debate regarding the most appropriate type of endotoxin to use in Low Endotoxin Recovery (LER) Hold Time Studies. PDA Technical Report 82 (TR82) recommends Reference Standard Endotoxin (RSE) and Control Standard Endotoxin (CSE) as the primary choices. Natural Occurring Endotoxins (NOEs) may be included as supportive data.
However, their relevance remains controversial due to concerns that they may not accurately represent the type of endotoxin contamination likely to be encountered in actual drug products. In this study, we investigated the use of unprocessed water samples collected from Water for Injection (WFI) systems as a natural source of endotoxin. These samples, without undergoing any purification, were used to spike a formulation matrix relevant to biopharmaceutical products. The goal was to evaluate their behavior and reliability in LER studies.
This study, conducted by directly inoculating samples with naturally contaminated water, did not show relevant differences compared to results obtained using purified endotoxins (RSE and CSE). Therefore, there is no clear reason IF these COULD REPLACE the STANDARIZED worst-case model based on RSE.
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Poster initially presented at the 2025 PDA Pharmaceutical Microbiology Conference
