Characterization of Residual Impurities in Gene Therapy Drug Products


26th January 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Jessica Townsend, Senior Manager Analytical Development at bluebird bio |BOOK FREE SEAT FOR THIS WEBINAR

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 talk will focus on risk assessment and characterization of product-related impurities in lentiviral vector-based gene therapy products.

Presented by Jessica Townsend, Senior Manager Analytical Development at bluebird bio

Jessica Townsend is Senior Manager of Analytical Development at bluebird bio (located in Cambridge, MA). Ms. Townsend received her BA in Biology from Minot State University and her MS in Molecular and Cellular Pharmacology from the University of Wisconsin, Madison. Following graduation, she spent 10 years developing molecular diagnostics for infectious diseases utilizing PCR techniques and was instrumental in several successful FDA 510(k) submissions prior to making the transition to gene therapy. At bluebird bio, Ms. Townsend leads the Analytical Development Lentiviral Vector Assays and Residuals team who develop and support the methods used for characterization testing of residual impurities in gene therapy drug products.


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