2/3 March 2021
In the field of testing bacterial endotoxins, testing with recombinant test systems is available in addition to testing with the classic lysate of horseshoe crabs (LAL). With regard to this possible alternative and in connection with the European initiatives to reduce tests and trials involving animals, the European Pharmacopoeia (Ph. Eur.) has published a new chapter - 2.6.32. Test for bacterial endotoxins with recombinant factor C (rFC) - for public consultation.
This is not a new topic in the European Pharmacopoeia in the strict sense. The EP was one of the first pharmacopoeias to refer to rFC, namely in Chapter 5.1.10 Guidelines for the use of the test for bacterial endotoxins in Supplement 8.8 (2016). It already describes that the recombinant protein can be used as an alternative to Limulus amebocyte lysate. Now, with its own chapter, the Ph. Eur. goes one step further. This is also important because LAL is currently dependent on a single lysate source, the Arrowtail Cancer family, and in particular on two cancers, Limulus polyphämus and Tachypleus tridentatus, known to be at risk.
The new chapter describes the test, which is based on a recombinant factor C and a fluorimetric endpoint detection method. Underlying is a gene sequence of arrowtail cancer. Chapter 2.6.32. initially describes only the fluorimetric method, as the rFC kits currently available on the European market and most available scientific data are based on this method.
It is important to note that it will be a separate chapter for the time being, which is therefore not referred to in individual monographs.
Users and other interested parties can submit their comments on the text published in Pharmeuropa 31.1 by 31 March 2019 via the EDQM online helpdesk. Detailed information and the text to be commented can be found after registration under Pharmeuropa texts for comment.