In this podcast, Hugh Davis, Chief Business Officer at Frontage Laboratories, discusses how bioanalytical laboratories like Frontage keep up with the latest therapies, challenges of a clinical development program design, bioanalytical considerations in developing assays, and the future of this field in the next 5-10 years.
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Frontage’s Biologics, Gene, and Cell Therapy Operations (BGC) Unit supports the development of biologics products. We develop complex analytical techniques to support drug substances, drug products, comparability studies, and stability programs.
Gene therapy holds the promise to transform medicine and creates options for patients who are living with incurable diseases. The industry has been booming in the last 20 years. Before a gene therapy product can be used in humans, the product must be tested for safety and effectiveness. This webinar focuses on the introduction of three critical test methods: AUC, Infectivity and RCL assays. Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.
Gene therapy has become a one-time treatment method for a complete cure by fixing genomic errors which altered the protein functions of normal cells. The high titer virus packaging and purity are essential for the success of clinical gene therapy. In this presentation, Dr. Rejean Wang, reports on establishing a facility to manufacture GLP-grade viruses and to develop the relevant QC assays at Frontage. Our efforts will facilitate the application of this modern cutting-edge technology in the clinical arena.