Michael G Tovey
Ecole Normale Supérieure, France
Title: High throughput assays for the determination of the potency and comparability of biosimilars and innovator products
Biography
Biography: Michael G Tovey
Abstract
Successful development of biosimilars is dependent upon the establishment of validated and standardized assays that allow direct comparisons of the relative potency and comparability of innovator molecules and biosimilars. A validated standardized high throughput assay platform will be described in this presentation that is applicable to most biopharmaceuticals and that allows direct comparison of drug potency and comparability of innovator molecules and biosimilars in the same assay. Case studies will be presented for biopharmaceuticals ranging from novel forms of human insulin and FGF-21 to bevacizumab, trastuzumab, and structurally diverse TNF-α antagonist.