IQ Consortium Biologics CMC Subvisible Particles Working Group Case Study
Subvisible particles (SVP, 2-100 µm) and submicron particles (SMP, 0.1-2 µm) in therapeutic protein products are topics of high interest for drug product developers and regulators due to their potential to elicit an immunogenic response that may affect drug safety and efficacy. Currently, there is no clear guidance on how and when to measure SMP. Limited information is available on the level of SMP in clinical and commercial products. Although SMP instruments are available, the robustness and performance of these detection methods and their proper use for routine characterization of clinical and commercial products still needs to be explored in more detail.