Reich, Johannes and Lang, Pierre and Grallert, Holger and Motschmann, Hubert (2016) Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems. BIOLOGICALS, 44 (5). pp. 417-422. ISSN 1045-1056, 1095-8320
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Over the last few decades Limulus Amebocyte Lysate (LAL) has been the most sensitive method for the detection of endotoxins (Lipopolysaccharides) and is well accepted in a broad field of applications. Recently, Low Endotoxin Recovery (LER) in biopharmaceutical drug products has been noticed, whereby the detection of potential endotoxin contaminations is not ensured. Notably, most of these drug products contain surfactants, which can have crucial effects on the detectability of endotoxin. In order to analyze the driving forces of LER, endotoxin detection in samples containing nonionic surfactants in various buffer systems was investigated. The results show that the process of LER is kinetically controlled and temperature-dependent. Furthermore, only the simultaneous presence of nonionic surfactants and components capable of forming metal complexes resulted in LER. In addition, capacity experiments show that even hazardous amounts of endotoxin can remain undetectable within such formulation compositions. In conclusion, the LER phenomenon is caused by endotoxin masking and not by test interference. In this process, the supramolecular structure of endotoxin is altered and exhibits only a limited susceptibility in binding to the Factor C of Limulus-based detection systems. We propose a two-step mechanism of endotoxin masking by complex forming agents and nonionic surfactants. (C) 2016 The Author(s). Published by Elsevier Ltd on behalf of International Alliance for Biological Standardization.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | AMEBOCYTE LYSATE ASSAY; DIVALENT-CATIONS; LIPOPOLYSACCHARIDE; PROTEINS; REMOVAL; Endotoxin; Lipopolysaccharide; Low endotoxin recovery; LER; Limulus amebocyte lysate; LAL |
| Subjects: | 500 Science > 540 Chemistry & allied sciences |
| Divisions: | Chemistry and Pharmacy > Institut für Physikalische und Theoretische Chemie Chemistry and Pharmacy > Institut für Physikalische und Theoretische Chemie > Chair of Chemistry VI - Physical Chemistry (Solution Chemistry) > Prof. Dr. Hubert Motschmann |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Mar 2019 14:37 |
| Last Modified: | 04 Apr 2019 12:01 |
| URI: | https://pred.uni-regensburg.de/id/eprint/3395 |
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