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 Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.
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Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists. We specialize in analytical method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing. Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations and commercial drug products.
Due to their size, nature, and biological origin, biologics or biopharmaceuticals are inherently complex in terms of quality attributes. Establishing and monitoring the quality attributes of a biologics is essential to ensure its efficacy and safety. Frontage offers the technical expertise and state-of-the-art instrumentation necessary for biologics characterization and analytical method development/validation. The biopharmaceuticals Frontage has supported include polysaccharides, fusion proteins, monoclonal antibodies, antibody drug conjugates (ADCs), vaccines, and gene therapy products.
In this webinar, Dr. Santosh Shah discusses the general industry standards for utilizing critical reagents in bioanalytical labs, importance of bridging various lots of critical reagents and maintaining stocks, and reviews proper storage, management, and documentation of critical reagents.