The field of bacterial endotoxin testing (BET) continues to undergo transformation with the introduction and implementation of recombinant technologies. Au fur et à mesure que ces nouvelles méthodes gagnent du terrain, les directives de la pharmacopée évoluent afin de s’adapter et de réglementer leur utilisation.
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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Auteur : Hayden Skalski, spécialiste de l’application des produits pour les sciences de la vie, Veolia | Water Tech, Sievers Instruments
Hayden est le spécialiste de l’application des produits des sciences de la vie pour la gamme de produits Sievers Instruments, spécialisé dans les tests d’endotoxines bactériennes (TEB). Hayden a plus de 8 ans d’expérience dans l’industrie pharmaceutique et le contrôle de la qualité microbiologique et a fait des présentations sur de nombreux sujets entourant les tests d’endotoxines. Auparavant, Hayden a occupé des postes chez Charles River Laboratories, Regeneron et Novartis, où il a validé et exécuté des protocoles de développement de méthodes pour les tests d’endotoxines, en assurant l'assistance à la clientèle, le dépannage et la prise en charge des tests de produits en grand volume. Hayden est titulaire d’un B.S. de l’Université d’Albany (SUNY) en biologie.