The
test for bacterial endotoxins using recombinant factor C (rFC) is carried out
to quantify endotoxins from Gram-negative bacteria. It is performed using rFC based
on the gene sequence of the horseshoe crab, using a fluorimetric method.
The
European Pharmacopoeia (Ph. Eur.) has launched a public consultation on a new
general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor
C (rFC). This is not a new topic for the Ph. Eur. which was one of the first
pharmacopoeias to refer to rFC, namely in chapter 5.1.10 Guidelines for using
the test for bacterial endotoxins in Supplement 8.8 (2016), allowing the recombinant
protein to be used as an alternative to limulus amoebocyte lysate. Now, the Ph.
Eur. is moving another step forward by publishing a standalone chapter on the
test for bacterial endotoxins (BET) using rFC. This is a significant
development since, for the BET, the world currently depends on a single source
of lysate, the horseshoe crab family, and more specifically, two species of the
crab, Limulus polyphemus and Tachypleus tridentatus, both of which
are known to be endangered.
This
chapter describes a BET that uses a rFC based on the gene sequence of the
horseshoe crab for the quantification of endotoxins from gram-negative
bacteria, and a fluorimetric end-point detection method. For now, only the
fluorimetric method is described in the new chapter as the rFC kits currently
available on the European market and most of the available scientific data are
based on this method.
It
is important to highlight that for the time being, this will be a standalone
chapter which will therefore not be referenced in individual monographs.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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Pharmaceutical Microbiology