Application Note

AAV Thermostability Assessment With Micro-Flow Imaging

Source: bio-techne
MFI system

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.

access the Application Note!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Cell & Gene