Size Exclusion Isotope Dilution Mass Spectrometry: An Alternative Assay for Influenza Vaccine Potency Determination

摘要

SEC has been demonstrated as a method to probe the distribution of different active forms of HA in influenza vaccine preparations. The change in the total quantity of HA and its SRID activity can be followed over time when a vaccine sample is subjected to temperature stress. The fractions containing SRID activity are observed consistently from run to run. (Figure 4) The results of the stability study suggest that while total detected HA at 7 days does decrease due to aggregation and precipitation, the normalized proportion of SRID activity does not change significantly (Figure 6). This suggests that the primary loss of protein is through monomeric HA, fragments or higher aggregates.