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Gene therapies using adeno-associated viruses (AAVs), lentiviruses, lipid nanoparticles (LNPs), and other vectors have shown promise for treating genetic diseases or other rare indications. These vectors can aggregate to form subvisible particles (those 2-100 μm in diameter) that may impact product quality and safety. Strategies for monitoring these particles can help researchers improve product stability, ensure product safety, and meet pharmacopeia guidelines on subvisible particles such as USP <788>.
Flow imaging microscopy (FIM) is a common analytical technique for monitoring subvisible particles in biotherapeutics. This webinar will introduce FIM and discuss how it can be used to monitor subvisible particles in gene therapy drug products. We will also present a case study in which FIM was used to analyze AAV formulations during an accelerated stability study. These measurements were used to investigate the impact of formulation ionic strength and different accelerated stability stresses on AAV aggregation. Applications for monitoring subvisible particles in other types of gene therapies will also be discussed.
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Gene therapies using adeno-associated viruses (AAVs), lentiviruses, lipid nanoparticles (LNPs), and other vectors have shown promise for treating genetic diseases or other rare indications. These vectors can aggregate to form subvisible particles (those 2-100 μm in diameter) that may impact product quality and safety. Strategies for monitoring these particles can help researchers improve product stability, ensure product safety, and meet pharmacopeia guidelines on subvisible particles such as USP <788>.
Flow imaging microscopy (FIM) is a common analytical technique for monitoring subvisible particles in biotherapeutics. This webinar will introduce FIM and discuss how it can be used to monitor subvisible particles in gene therapy drug products. We will also present a case study in which FIM was used to analyze AAV formulations during an accelerated stability study. These measurements were used to investigate the impact of formulation ionic strength and different accelerated stability stresses on AAV aggregation. Applications for monitoring subvisible particles in other types of gene therapies will also be discussed.
Speaker Information
Austin Daniels, Ph.D.
Austin Daniels is an application scientist for Yokogawa Fluid Imaging Technologies. His work focuses on the applications of flow imaging microscopy and artificial intelligence-driven image analysis tools. Austin has a PhD in Chemical and Biological Engineering from the University of Colorado.