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Endotoxin Process Removal

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Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems

Abstract

Endotoxin, also known as pyrogens, are lipopolysaccharides (LPS). LPS is a major component of the outer membrane of the cell wall in Gram-negative bacteria. The presence of LPS in the pharmaceutical final product will lead to severe patho-physiological effects, like sepsis, organ failure, tissue damage, shock, and even death (J Microbiol Methods 132:153–159, 2017). It is crucial and required by pharmaceutical regulations that only up to 0.2 (injectable, intrathecal) or 5 (injectable, non-intrathecal) Endotoxin unit(EU) per kilogram of body weight are permitted in drug products (Department of Health, Education, and Welfare Public Health Service Food and Drug Administration, “Bacterial endotoxins/pyrogens,” 85, p. 40.). The various methods used to accomplish the task of endotoxin process removal are discussed.

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  1. Bolt Biotherapeutics, Inc., Redwood City, CA, USA

    Yuyi Shen

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  1. Yuyi Shen
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Correspondence to Yuyi Shen .

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  1. bioMérieux Inc., Durham, NC, USA

    Kevin L. Williams

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Shen, Y. (2019). Endotoxin Process Removal. In: Williams, K. (eds) Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems. Springer, Cham. https://doi.org/10.1007/978-3-030-17148-3_9

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