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Endotoxin detection is vital for pharmaceutical safety. While traditional methods have depended on animal-based testing, the industry is undergoing a significant shift with the rise of recombinant technologies and updates reflected in USP Chapter <86>.
In a recent webinar led by Holly Kabrick, Product Manager at Lonza, expert Allen L. Burgenson discussed the shift toward recombinant technologies, including recombinant Factor C assays, and the impact of USP <86>. This article highlights key insights on the evolving science and regulatory future of pyrogen testing. Download the article to explore developments in recombinant testing, validation challenges, regulatory expectations, and more.