PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Regular Article
The Future is Now: Endotoxin Testing Using Sustainable Reagents based on Recombinant Horseshoe Crab Factor C
Gregory DEVULDERKevin WILLIAMS
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2020 Volume 22 Issue 1 Pages 1-5

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Abstract

Since the initial exploratory use of LAL for radiopharmaceutical testing was found, several widespread paradigm changes have occurred in the past 50 years including (a) the LAL test supplanted the rabbit pyrogen test (RPT) as a method of precluding fever reactions in patients subject to injectable drug treatments. However, the source material, horseshoe crab, is a Red List registered species (endangered species). Therefore, a test method alternative to the LAL teat that can be continuously supplied has been sought.


“Endotoxin Testing Using Sustainable Reagents based on Recombinant Horseshoe Crab Factor C” is introduced in this report as an alternative method to the LAL test. The main advantages of the rFC method are introduced below.

 (a) sustainability via “at will” production,

 (b) attributes of a natural biosensor,

 (c) absence of Factor G and thus beta-glucan reactivity,

 (d) sensitivity to endotoxin detection

 (e) ability to automate and iterate

 (f) simplification of the test milieu

 (g) ease of validation.


The usefulness of the rFC method has already been proved, while the death of the horseshoe crab due to environmental changes is unavoidable, and the continued use of the horseshoe crab is impossible. The pharmaceutical industry should be prepared for this switch from LAL to rFC. And this need has been clarified by regulatory agencies.

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© 2020 Parenteral Drug Association Japan Chapter
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