Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule drugs, their structures are complex and they can assert their effects by binding with high specificity to more than one target molecule. During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis is reviewed along with the use of these assays for assessment of drug potency and stability.
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