Endotoxin Detection Challenges Associated With The Development Of A Novel VLP

Endotoxins, otherwise known as lipopolysaccharides (LPS), are non‑infectious pyrogens associated with the cell membrane structure of Gram‑negative bacteria. This presentation outlines endotoxin detection challenges encountered during the development of a novel virus-like particle (VLP). Furthermore, this presentation provides a review of current methodologies accepted within industry to measure both endotoxin (i.e., LPS) and non-endotoxin pyrogens (NEPs). There is no specific endotoxin test for VLPs, but they can be problematic during downstream processing, so the focus of the seminar would be to discuss approaches to address endotoxins/pyrogens, including the testing. General benefits/limitations from a scientific/regulatory compliance for each endotoxin/pyrogen test will also be discussed.