The field of bacterial endotoxin testing (BET) continues to undergo transformation with the introduction and implementation of recombinant technologies. À medida que esses novos métodos ganham força, as diretrizes da farmacopeia estão evoluindo para acomodar e regular seu uso.
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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Autor: Hayden Skalski- Especialista em aplicação de produtos para ciências da vida, Veolia | Water Tech, Instrumentos Sievers
Hayden é especialista de Aplicação de Produtos de Ciências da Vida para a linha de produtos Sievers Instruments, especializada em testes de endotoxinas bacterianas (BET). Hayden tem mais de 8 anos de experiência na indústria farmacêutica e em microbiologia de controle de qualidade e apresentou vários tópicos relacionados a testes de endotoxinas. Anteriormente, Hayden ocupou cargos na na Charles River Laboratories, na Regeneron e na Novartis, validando e executando protocolos de desenvolvimento de métodos para testes de endotoxinas, fornecendo suporte ao cliente, solução de problemas e suporte a testes de produtos de alto volume. Hayden é bacharel em Biologia pela Universidade de Albany (SUNY).