The Future of Endotoxin Testing: USP Chapter 86 and the Shift to Recombinant Methods

[Article Title]

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods in the newly published USP Chapter <86>.

This white paper covers an overview of USP Chapter <86>, the advantages of recombinant reagents, the main challenges faced by companies when transitioning from LAL to rFC testing, future trends, and more.

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