Problem to be solved: to provide an assay based on biophysical measurements (contrasted with immunochemical measurements) to identify structural differences between active immunogenic conformation and inert counterparts.The present invention provides an improved SDI assay that has been modified to utilize the ability to differentiate the benefit of biological proteolysis described herein, i.e., the immunogenic forms of HA and the low immunogenic forms of HA described herein.Another aspect of the present invention provides a step assay for improving the accuracy of assay in determining the amount of immunologically active HA in the sample, incorporating steps of biological proteolysis (e.g., trypsin pretreatment) prior to the SRID.Diagram
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