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The field of bacterial endotoxin testing (BET) is undergoing a significant transformation with the introduction of recombinant technologies. As these new methods gain traction, pharmacopeia guidance is evolving to accommodate and regulate their use.
A major development in this area is the upcoming publication of a new compendial chapter in the United States Pharmacopeia (USP). The chapter, USP <86> "Bacterial Endotoxins Test Using Recombinant Reagents," is set to become official in 2025. This new guidance will allow for the implementation of non-animal derived reagents, such as recombinant Factor C (rFC) and recombinant Cascade Reagent (rCR), in the detection and quantification of bacterial endotoxins.
The significance of this new chapter marks an important milestone in endotoxin testing. Currently, recombinant reagents are considered alternative methods, requiring users to undergo extensive alternative method validation. However, with the implementation of USP <86>, users will be able to choose between traditional Limulus Amebocyte Lysate (LAL) and recombinant reagents without the need for this additional validation step.
This change in pharmacopeia guidance is expected to streamline the adoption of recombinant reagents in BET procedures. It addresses one of the main hurdles in the widespread use of these innovative methods - the regulatory burden of proving comparability to traditional LAL methods. To prepare for this transition, laboratories are encouraged to conduct comparability studies between their current LAL methods and recombinant reagents. This can involve side-by-side testing of samples using both methods on platforms such as the Sievers Eclipse, which has demonstrated compatibility with both LAL and recombinant reagents.
As we approach 2025, the BET landscape is poised for significant change. The new pharmacopeia guidance will likely accelerate the adoption of recombinant technologies, offering potential benefits in terms of sustainability, consistency, and possibly improved sensitivity in endotoxin detection. Laboratories and quality control professionals should stay informed about these developments and consider how they might integrate recombinant methods into their testing protocols. As always, adherence to regulatory guidelines and thorough validation of any new methods will be crucial in ensuring the continued safety and quality of pharmaceutical products.
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Author:?- Life Sciences Product Application Specialist, 91大神Water Technologies & Solutions, Sievers Instruments
Hayden is the Life Sciences Product Application Specialist for the Sievers Instruments product line, specializing in bacterial endotoxins testing (BET). Hayden has over 8 years of experience in the pharmaceutical industry and Quality Control Microbiology and has presented on numerous topics surrounding endotoxin testing. Previously, Hayden held roles at Charles River Laboratories, Regeneron and Novartis, validating and executing method development protocols for endotoxin testing, providing customer support, troubleshooting and supporting high-volume product testing. Hayden has a B.S. from the University at Albany (SUNY) in Biology.