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<86> Bacterial Endotoxins Test Using Recombinant Reagents

Type of Posting: General Announcement
Posting Date: 22–Aug–2023
Expert Committee: General Chapters Microbiology Expert Committee

USP recognizes the need for a standard with information on the use of additional reagents for bacterial endotoxins testing. More specifically, we acknowledge the need for information to help drive the adoption of recombinant reagents as alternatives to naturally sourced reagents from horseshoe crabs.  This approach advances USP’s commitment to transition methods from using animal-derived materials to synthetic and recombinant materials.  

In a recent publication in the Pharmacopeial Forum 45(5) [Sep.-Oct. 2019], the USP Microbiology Expert Committee (EC) proposed the inclusion of recombinant factors for endotoxin testing in chapter <85> Bacterial Endotoxins Test (currently, the official procedure is based on the naturally derived reagent, LAL). Based on public comments received, the EC decided to cancel this proposal and start the development of a separate informational chapter to expand on the use, validation, and comparability of endotoxin tests based on recombinantly derived reagents.

The proposed informational chapter <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test - Photometric and Fluorometric Methods Using Recombinantly Derived Reagents was published in the Pharmacopeial Forum 46(5) [Sep.-Oct. 2020]. Based on the comments received, the Microbiology EC canceled this proposal and the current EC developed proposed <86> Bacterial Endotoxins Test Using Recombinant Reagents to provide additional techniques using nonanimal derived reagents to the Bacterial Endotoxins Test <85>. This chapter is not currently being proposed for introduction into a monograph or General Notices. The proposal includes information on:

  • The responsibility of the user to review supplier’s primary validation package,
  • Verification of product suitability for use in testing products or materials (referencing <1226> Verification of Compendial Procedures),
  • The possibility that supplemental data (e.g., comparative study) may be required by regulatory authorities prior to acceptance.

<86> Bacterial Endotoxins Test Using Recombinant Reagents will be published in Pharmacopeial Forum 49(6) [Nov.–Dec. 2023]. This proposal will include methods for recombinant Factor C (rFC) and recombinant cascade reagents (rCR). The purpose of this General Announcement is to inform stakeholders of the upcoming publication and to provide an early posting of the proposal to allow ample time for review and comment.

Please click here to download the revision proposal.

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