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 Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.

Frontage offers extensive experience and advanced technology in biomarker assay development, validation, and testing, adhering to CAP, CLIA, GLP, and GCLP standards.

​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.