Cellular and gene therapies involve the delivery of genetic material to manipulate an individual’s cell for the treatment of different diseases including cancers and inherited disorders. With the number of gene therapy products in development increasing, bioanalytical methods are playing an important role in ensuring the success of these novel therapies.
As potential cell and gene therapies are investigated, it is essential to use bioanalytical methods to quantify the DNA, the vector and the expressed gene moieties to gain a complete understanding of PK, PD and safety.
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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 Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.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.
In this infographic, we talk about key trends in cellular and gene therapies.