Impurities in Gene Therapy Products

 Analysis of impurities is one of the critical steps in ensuring the safety of pharmaceuticals, including
biologics such as monoclonal antibodies, and gene therapy products. Traditional methods for measurement of impurities are useful for gene therapy products, but a few additional techniques are needed to specifically address potential impurities for gene therapy applications. We'll look at approaches to investigate the variety of potential impurities that may be a cause of concern in development.  

Mike Molloy, Technical Director, Boston Analytical & Karina Allen-Ludwig, Senior Scientist, Boston Analytical