General chapter on the rFC test adopted by the European Pharmacopoeia Commission
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
IN NOVEMBER 2019, the European Pharmacopoeia (Ph. Eur.) Commission adopted 13 new monographs and four new general chapters. Among the new chapters is Chapter 2.6.32, titled ‘Test for bacterial endotoxins using recombinant factor C (2.6.32)’. This will be published in the coming weeks in Ph. Eur. Supplement 10.3 and available on the European Directorate for the Quality of Medicines (EDQM) website. The chapter will be effective at the start of next year (1 January 2021).
In January 2019, the Ph. Eur. launched a public consultation for preparing the new general chapter and was the first pharmacopoeia to refer to the rFC test, which they did in chapter 5.1.10, ‘Guidelines for using the test for bacterial endotoxins.’
“As stated in the General Notices, the test methods given in monographs and general chapters have been validated in accordance with accepted scientific practice and current recommendations on analytical validation. In consequence, the methods described in general chapters 2.6.14. Bacterial endotoxins, 2.6.30. Monocyte-activation test and 2.6.32. Test for bacterial endotoxins using recombinant factor C therefore do not have to be re-validated per se, other than in consideration of their use for a specific substance or product in a specific analytical environment.”