Low endotoxin recovery and its impact on endotoxin detection

doi:10.1002/bip.23470

Review

. 2021 Nov;112(11):e23470.

doi: 10.1002/bip.23470. Epub 2021 Aug 18.

Low endotoxin recovery and its impact on endotoxin detection

Yuan Cao¹, Yujie Zhang¹, Frank Qiu¹

Affiliations

PMID: 34407207
DOI: 10.1002/bip.23470

Review

Low endotoxin recovery and its impact on endotoxin detection

Yuan Cao et al. Biopolymers. 2021 Nov.

. 2021 Nov;112(11):e23470.

doi: 10.1002/bip.23470. Epub 2021 Aug 18.

Authors

Yuan Cao¹, Yujie Zhang¹, Frank Qiu¹

Affiliation

¹ Department of Process Development, BeiGene Guangzhou Biologics Manufacturing Co., Ltd., Guangzhou, China.

PMID: 34407207
DOI: 10.1002/bip.23470

Abstract

Endotoxin exists on the outer membrane of Gram-negative bacteria and poses risks to human health by triggering a series of immune responses. Therefore, its accurate detection is essential. The Limulus amoebocyte lysate (LAL) test is the most pharmacopeia-recognized and popular technique for endotoxin detection. Despite its wide industry adoption, the low endotoxin recovery (LER) phenomenon can compromise the LAL test's reliability. This review summarizes the possible reasons attributing to the LER phenomenon from three different perspectives: the endotoxin standards used in hold time study, protein active pharmaceutical ingredients, and excipients. Potential mechanisms and strategies to mitigate the LER phenomenon are also discussed as presented by different research groups.

Keywords: Tachypleus amebocyte lysate assay; endotoxin; formulation buffers; limulus amebocyte lysate assay; lipopolysaccharides; low endotoxin recovery.

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References

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[1] J. J. Philippé, M. L. De Buyzere, Acta Clin. Belg. 1988, 43, 429.

[2] J. J. Philippé, M. L. De Buyzere, Acta Clin. Belg. 1988, 43, 429.

[3] C. Galanos, O. Luderitz, in Chemistry of Endotoxin, Vol. 1 (Ed: E. T. Rietschel), Elsevier Science Publishers B. V., Amsterdam 1984, p. 46.

[4] C. Galanos, O. Luderitz, in Chemistry of Endotoxin, Vol. 1 (Ed: E. T. Rietschel), Elsevier Science Publishers B. V., Amsterdam 1984, p. 46.

[5] K. Brandenburg, H. Mayer, M. H. Koch, J. Weckesser, E. T. Rietschel, U. Seydel, Eur. J. Biochem. 1993, 218, 555.

[6] K. Brandenburg, H. Mayer, M. H. Koch, J. Weckesser, E. T. Rietschel, U. Seydel, Eur. J. Biochem. 1993, 218, 555.

[7] H. Loppnow, H. Brade, I. Dürrbaum, C. A. Dinarello, S. Kusumoto, E. T. Rietschel, H. D. Flad, J Immunol 1989, 142, 3229.

[8] H. Loppnow, H. Brade, I. Dürrbaum, C. A. Dinarello, S. Kusumoto, E. T. Rietschel, H. D. Flad, J Immunol 1989, 142, 3229.

[9] T. H. Pohlman, R. S. Munford, J. M. Harlan, J. Exp. Med. 1987, 165, 1393.

[10] T. H. Pohlman, R. S. Munford, J. M. Harlan, J. Exp. Med. 1987, 165, 1393.

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Low endotoxin recovery and its impact on endotoxin detection

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Low endotoxin recovery and its impact on endotoxin detection

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