There has been an increase in pressure by regulatory authorities in Europe to replace the rabbit pyrogen test (RPT) with in vitro alternatives such as the compendial Limulus Amebocyte Lysate (LAL) test or the alternative Monocyte Activation Test (MAT). On the other hand, the FDA requests companies provide supporting data to the LAL test where low endotoxin recovery (LER) is questioned on biological drug products. So, which pyrogen detection approach is best suited for your drug or device?
Join us to learn the benefits, drawbacks, and latest trends regarding these globally recognized pyrogen detection methodologies.
Katarzyna Marciniak-Darmochwal, PhD
Analytical Services Department Manager