11^th European Biosimilars Congress

Since originator recombinant proteins are getting off patent, biosimilar molecules are entering the market. Although the overall costs of bringing a biosimilar product to the market is in general much lower than for an originator, the technical challenges to reach biosimilarity compared to originator product are significant. There is also a strong push to bring down the cost of goods to manufacture these products. Strategies will be presented to reach technical proof of similarity of specific antibodies while reducing production costs. These include innovative concepts to increase antibody titers on our CHOBC® platform using our SPOT™ technology and our USP toolbox to modulate relevant post-translational modifications like glycosylation and charge variants. In addition, these include, selection of new Protein A resins to decrease cost of goods while maintaining product quality, the development of high throughput methods, including Multi-Attribute Methods (MAM), to increase efficiency, and the extensive characterization of antibody charge variants (eg oxidation, deamidation, fucosylation, lysine truncation etc.) and disulfide linkage analysis to increase product knowledge.