On Tuesday, 4 June 2019, Andy Topping, chief scientific officer of FUJIFILM Diosynth Technologies, spoke to the BPI Theater at BIO about analytical methods for viruses and gene therapy products. Effective analysis, he argued, requires methods from both classic and contemporary virology, as well as means that have long been used for more traditional biologic products. Even basic questions about a gene therapy product — about how much product you have made, how many vials have been filled, and what they are filled with — are easy to ask but difficult to answer, requiring multiple modes of investigation. With this multifaceted approach, a company can build confidence about realizing results.
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