A Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
Presenter: Lindsey Crawford, PhD (Pfizer)
Presented by the IQ Subvisible Particles Working Group (Biologics CMC Leadership Group)
In the last few decades there has been an increased interest in characterizing subvisible particles within biotherapeutic drug development. While many studies have evaluated technologies and methodologies for characterizing subvisible particles, the majority of these studies have focused on particles 2 µm and greater. There has been interest from regulatory agencies around particles less than 1 µm, namely submicron particles, due to limited public data available in this size range and modern submicron particle technologies such as resonant mass measurement and particle tracking.
This webinar will provide an overview of an industry wide effort to determine potential uses and pitfalls of submicron particle technologies by utilizing methods run across various labs and companies and comparing the accuracy of the data. It will also serve to tease out any early trends seen between various products and their submicron particle levels.