Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations

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Application Note SIMI: A Different Approach to Revealing Dangerous Subvisible Impurities Waters Corporation, United States Published on November 06, 2025 Introduction Foreign particulate matter, also known as extrinsic particles, has become a serious threat to patient safety in recent years,…

Application Note AAV Aggregate Quantitation and Identification with the Aura System Waters Corporation, United States Published on November 06, 2025 Introduction Adeno-associated viruses (AAVs) have transformed gene therapies by enabling the targeted delivery of curative genetic payloads.1 However, the amount…

Application Note Identify and Characterize Particles in the Visible Size Range with Aura Waters Corporation, United States Published on November 06, 2025 Introduction Characterizing large visible contaminants is essential for patient safety and mandated by both USP 788, 790, and…