The bacterial endotoxin test is a mainstay of quality and safety in pharmaceutical manufacturing. However, the need for improved efficiency and standardisation across the industry as a whole is driving considerable discussion regarding the best use of the limulus amebocyte lysate (LAL) test to maximise quality and patient safety.
Here, we review some of the hot topics that dominate the agenda when experts from across the endotoxin community are brought together, as demonstrated at the 2nd Global Endotoxin Summit.
Such topics include the considerable debate about the best way to deal with low endotoxin recovery (LER), concerns regarding the appropriate testing of pyrogenic contamination in pharmaceutical products, and disagreement about the most effective standards to use for spike-in controls. Data integrity is also growing in importance.
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