Defining the “active ingredient” is the central challenge of biologic PTE, because biologics are large, complex molecules that do not fit neatly into a statutory framework built for small molecule drugs.
Jessica von Reyn
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Jessica von Reyn is a Shareholder in the Biotechnology practice at Wolf Greenfield. She practices extensively in the areas of immunotherapy, vaccine development (including mRNA vaccines), cellular engineering, antibodies, gene therapies, drug delivery, cell culture and assay design, nucleic acid sequencing, and antisense nucleic acid therapeutics.
Articles by Jessica von Reyn
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