AAV Thermostability Assessment With Micro-Flow Imaging

Impurities such as aggregates and particulates can find their was into AAV-based gene therapy products as a result of environmental conditions, including temperature. These impurities can negatively impact their safety and efficacy. During development, subjecting AAVs and other biotherapeutic samples to different temperatures and analyzing them for impurities and stability is routine. Light obscuration (LO) and membrane microscopy are the analytical methods currently used in this process, however these are limited in their ability to provide some critical details. Automated and sophisticated techniques such as micro-flow imaging (MFI) are increasingly becoming the choice for SVP analysis to overcome these common shortcomings. The MFI system is an orthogonal technique to light obscuration and membrane microscopy for the analysis of SVPs, which are crucial in formulation development and stability studies. In this study a micro-flow imaging (MFI) system was used to demonstrate the methods ability to evaluate AAV9 particle purity and stability when subjected to heat stress at two different temperatures: 37°C and 75°C.