USP follows the 3R Principle - Implementation of new Chapter on recombinant Test Methods

Recommendation

11/12 March 2025
Berlin, Germany

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Alternative test systems for testing for endotoxins had already found their way into other pharmacopoeias some time ago, e.g. into the Ph.Eur. general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C. These methods have also been included in the water monographs since 2023.

Now the United States Pharmacopoeia (USP) is following suit. In August 2023, the new chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents was announced with a link to the draft of the corresponding document and the corresponding opportunity to comment.

Current development

On 26 July, the USP has published information on the approval of this chapter and the further procedure:

"The USP Expert Group on Microbiology has approved the inclusion of Chapter <86> “Bacterial Endotoxins Test Using Recombinant Reagents” in the United States Pharmacopeia-National Formulary (USP-NF), which allows the use of non-animal-derived reagents to test endotoxins. The final text of the chapter will be published for early adoption in November 2024 and will officially enter into force in May 2025."

The new chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents thus complements the previous chapter <85> Bacterial Endotoxins and deals with methods using both recombinant cascade reagents (rCR) and recombinant factor C reagents (rFC). The new chapter is intended to provide drug manufacturers of new and existing pharmaceutical products with information on how they can incorporate these methods into their quality testing. However, there is no obligation to replace previously used methods in accordance with Chapter <85>.

With this new chapter, the USP now follows the general approach of the 3R strategy with the aim of expanding the use of animal-free methods and reducing the use of animal testing or animal materials.

In this context - the annual conference on current developments in the field of endotoxin and pyrogen testing will be covered on 26/27 November as part of the PharmaLab Congress in Neuss/Düsseldorf.