Characterization Of Residual Impurities In Gene Therapy Drug Products

Characterization of residual impurities for gene therapy drug products is particularly challenging due to the complex nature of the final products as well as the complicated processes required to manufacture them. As these products advance through clinical development, the identification, characterization, and control of the process- and product-related impurities are important to define early on, and require careful assessment of impurity clearance and risk related to each impurity. This expert discussion focuses on risk assessment and characterization of product-related impurities in lentiviral vector-based gene therapy products.