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What is MS CS Low Endotoxin Recovery Hold Time about?

Low Endotoxin Recovery (LER) refers to the failure to detect spiked endotoxin levels in drug products, particularly those containing proteins with chelating agents. LER hold-time studies are essential for determining the impact of sample storage conditions on endotoxin activity and are required for Biologics Licensing Applications by the FDA and EMA. While LER raises regulatory concerns, there is no evidence to suggest it poses a patient safety risk.

Author

Oanh Tran

Language

EN