The field of bacterial endotoxin testing (BET) continues to undergo transformation with the introduction and implementation of recombinant technologies. A medida que estos nuevos métodos ganan terreno, las directrices de la farmacopea evolucionan para adaptarse y regular su 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 en aplicación de productos para ciencias biológicas, Veolia | Water Tech, Sievers Instruments
Hayden es el especialista en aplicación de productos de ciencias biológicas para la línea de productos de Sievers Instruments, que se especializa en pruebas de endotoxinas bacterianas (BET). Hayden tiene más de 8 años de experiencia en la industria farmacéutica y en microbiología de control de calidad, y ha realizado presentaciones sobre numerosos temas relacionados con las pruebas de endotoxinas. Anteriormente, Hayden ocupó cargos en Charles River Laboratories, Regeneron y Novartis, donde validó y ejecutó protocolos de desarrollo de métodos para pruebas de endotoxinas, brindó asistencia al cliente, resolvió problemas y brindó soporte para pruebas de productos de alto volumen. Hayden tiene una licenciatura en Biología de la Universidad de Albany (SUNY).