Method development, qualification and validation are at the core of our service portfolio. From product characterization to first-in-human to later stages of your drug development/approval cycle, we can support assay development and technology transfer, as well as method qualification and validation for GMP release and long-term stability studies of your drug substances and drug products.

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 Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.