Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
News|Articles|October 4, 2023
Using Non-Infectious MVM and RVLP Surrogates to Predict Viral ClearanceInsourcing Purification Workflows Improves Efficiency, Recovery, and Quality
Author(s)Cygnus Technologies
Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing.
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