Determining the Optimal Pyrogenicity Testing Approach for Your Product

Date

Thursday, June 27, 2019
11:00 AM - 12:00 PM EDT

Location

Online Webinar
gowned tech at flow hood using pipette

Overview

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.

 

Webinar Presenter

Katarzyna Marciniak-Darmochwal HEADSHOT

Katarzyna Marciniak-Darmochwal, PhD
Analytical Services Department Manager
Charles River

 
Have a scheduling conflict? Sign up even if you can't make it; we'll share the recording after.