The field of bacterial endotoxin testing (BET) continues to undergo transformation with the introduction and implementation of recombinant technologies. As these new methods gain traction, pharmacopeia guidance is evolving to accommodate and regulate their use.
A major development was the publication of a new compendial chapter in the United States Pharmacopeia (USP), USP <86> "Bacterial Endotoxins Test Using Recombinant Reagents," which became official in 2025. This guidance allowed 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 the new chapter marked an important milestone in endotoxin testing. Recombinant reagents were previously considered alternative methods, requiring users to undergo extensive alternative method validation. However, with the implementation of USP <86>, users are 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 aimed to streamline the adoption of recombinant reagents in BET procedures by addressing one of the main hurdles in the widespread use of these innovative methods - the regulatory burden of proving comparability to traditional LAL methods. To support this transition, laboratories have conducted comparability studies between LAL methods and recombinant reagents. This involves 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.
Since the changes in 2025 to pharmacopeia guidance, the pharmaceutical industry has increased adoption of recombinant technologies. These methods can offer benefits in terms of sustainability, consistency, and improved sensitivity in endotoxin detection.
Learn more: Navigating the Evolution of Endotoxin Testing - Comparing rFC and rCR Recombinant Alternatives to LAL
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作者：Hayden Skalski- Veolia | 水务技术Sievers分析仪生命科学产品应用专家
Hayden是Sievers分析仪产品线的生命科学产品应用专家，专门研究细菌内毒素检测 (BET)。Hayden在制药行业和质量控制微生物学领域拥有超过8年的经验，并就内毒素检测的众多主题发表过演讲。此前，Hayden曾在Charles River Laboratories、Regeneron和Novartis任职，负责验证和执行内毒素检测的方法开发方案，提供客户支持、故障排除和支持大批量产品测试。Hayden拥有奥尔巴尼大学 (SUNY) 生物学学士学位。