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USP Updates Chapter 〈1085〉: A Milestone for Recombinant Endotoxin Testing

In July 2025, the United States Pharmacopeia (USP) released a revised version of General Chapter 〈1085〉, titled “Guidelines for Bacterial Endotoxins Testing.” This update marks a significant step forward in the regulatory recognition of recombinant Factor C (rFC) methods and their role in sustainable, reliable endotoxin testing.

 

What’s New in Chapter <1085>?

The revised chapter, which will become official in February 2026, introduces key clarifications that directly impact how laboratories and manufacturers approach endotoxin testing:

  • Terminology Shift: the chapter now refers to “reagents” instead of “lysates.” This change is more than semantic: it broadens the scope of the regulation to explicitly include recombinant reagents, reaffirming their compendial status within the USP framework.
  • Regulatory Clarity for rFC: this update removes any possible uncertainty about the compendial status of rFC-based assays.
  • Defining Alternative Methods: the chapter also clarifies that any method outside the compendial framework - other than those described in Chapters 〈85〉 or 〈86〉 - will be considered alternative. These approaches must undergo full method validation and product-specific verification before being implemented in routine testing.

 

Why the updates in Chapter <1085> matter 

This update removes longstanding ambiguity in the industry and provides clear regulatory guidance for the use of recombinant technologies. It supports the continued adoption of ethical, animal-free methods for endotoxin testing, aligning with global efforts to reduce reliance on natural resources and improve consistency in quality control.

For manufacturers and QC laboratories, this means greater flexibility, improved sustainability, and confidence in adopting innovative recombinant solutions without compromising compliance.

 

bioMérieux's commitment

At bioMérieux, we welcome this regulatory evolution. As a pioneer in microbiological quality control, we are committed to supporting our partners with cutting-edge, compliant, and ethical solutions that meet the highest standards of safety and reliability.

 

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