Patent ID: 8283452
Filing Date: 2012-10-09
Classification: A61K,C07K,C12N,G01N

Abstract:
1. A method for quantifying a hemagglutinin (“HA”) titer of an influenza antigen preparation comprising HA, the method comprising applying a reduced and derivatized antigen preparation comprising solubilized influenza HA that is cleaved into subunits HA1 and HA2 and a detergent in a pH controlled solution to a Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) column in an RP-HPLC system; eluting HA antigens from the RP-HPLC column with an ion-pairing agent in an organic mobile phase, and further wherein the HA antigens are derivatized with an alkylating agent; and measuring a peak area of the HA1 subunit of influenza HA in a chromatogram resulting from the elution to determine the HA titer of the influenza HA antigen preparation based on calibration of the RP-HPLC system with a reference concentration of influenza HA.