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European Biopharmaceutical Review

Endotoxins The Unwanted Contaminants in Biomaterials for Regenerative Medicines

In biomedical applications, the presence of lipopolysaccharides (LPS) is a significant cause for concern. What are LPS and the associated risks?

Elien Gevaert: LPS, also known as endotoxins, are toxins found in the outer membrane of gram-negative bacteria. They can initiate strong immune responses, mainly via interaction with Toll-like receptor 4 (TLR-4) expressed on the cell membranes of a variety of cell types. The human body can react to the presence of LPS with fever, chills, shaking, and sometimes respiratory symptoms. The presence of LPS in the circulation can lead to endotoxemia and possible anaphylactic shock, while chronic exposure to LPS can result in systemic inflammation and can aggravate existing diseases or create novel health problems.

Unsurprisingly, the FDA imposes strict regulations on the levels of endotoxins allowed for medical devices. For devices targeting the cardiovascular system, the endotoxin limit is 20 endotoxin units (EU)/device, while for those in contact with cerebrospinal fluid, the limit is even lower, at 2.15 EU/device.

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Dr Elien Gevaert holds a Master of Science in Biochemistry and Biotechnology. After obtaining a PhD in Biomedical Sciences in the field of liver tissue engineering, she joined the upper airways research lab at the University of Ghent/University Hospital, Belgium. There, Elien investigated the immunological mechanisms underlying airway inflammatory diseases as a postdoc for six years. Her academic career has resulted in more than 30 scientific publications in leading scientific journals. In 2020, she joined Rousselot as Principal Scientist. In her current position, she leads and coordinates several R&D projects with the aim of developing new and innovative gelatin-based products for nutritional or biomedical applications.
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