ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Cell wall debris (lypopolysaccharide) from Gram-negative bacteria.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

See also: Pyrogen


A poisonous molecule in the form of a fat/sugar complex (lipopolysaccharide) that forms an integral part of the bacterial (gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed and can cause septic shock and tissue damage. Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA product, thus necessitating purification steps to ensure their removal. In water treatment, it most often refers to pyrogens.

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