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 and Eric S. Bishop, Vice President of Research & Development at Cygnus Technologies |WATCH FOR FREE
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.
Followed by Eric S. Bishop, Vice President of Research & Development at Cygnus Technologies
Eric Bishop is the Vice President for Research and Development at Cygnus Technologies. Eric leads the research and development team and is responsible for new product development and custom development services. Eric has 20 years of experience in HCP analytics.Eric joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies.Prior to joining Cygnus, Eric worked for AstraZeneca, formerly MedImmune, from 2002-2010. During his time there he had multiple roles from HCP assay development and tech transfer to being Analytical Representative on CMC teams guiding projects from IND to BLA submissions as well as Head of New Technology Development group.Prior to AstraZeneca, he was at CropTech Development from 1998-2002, where he was involved in characterization of recombinant proteins produced in plants.
Sponsored by
Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions as well. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval, and commercial release.
Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Its reputation for quality is recognized by the industry and global regulatory agencies. It continues to advance the science of bioprocess impurity detection with new breakthroughs, including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that integrate Mass Spectrometry, AAE and ELISA and MockV™ virus clearance kits. Cygnus’ proprietary technology, available through its off-the-shelf and custom analytics programs, sets the gold standard for enabling HCP and other bioprocess impurity antibody and assay development. Cygnus’ quality management program and processes are ISO-9001:2015 certified.
Cygnus Technologies, headquartered in Southport, North Carolina, was founded in 1997 and is online at www.cygnustechnologies.com