Subvisible Particles: Why Don’t I Just Filter My Biologic Samples?

Application Note Accurate Particles Characterization in Lipid Nanoparticle Therapies Waters Corporation, United States Published on November 06, 2025 Introduction Lipid nanoparticles (LNPs) have emerged as one of the most promising drug delivery methods1. LNPs encapsulate genetic material in submicrometer sized…

Application Note High-Throughput Detection of Degraded Polysorbate in Biological Formulations with FMM Waters Corporation, United States Published on November 07, 2025 Introduction The FDA requires that all biologic formulations be free of visible particles and has defined allowable levels of…

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Application Note Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations Waters Corporation, United States Published on November 06, 2025 Abstract Subvisible particles (1 µm–100 µm) are a critical quality attribute for biologics and an indicator of stability. The presence…