Using Mass Spectrometry to Update Regulated Influenza Vaccine Production

摘要

Influenza viruses are highly transmissible respiratory pathogens that result in substantial morbidity and mortality. Vaccination is the most effective means to reduce influenza infection and is an integral part of public health strategies for the control of influenza. Inactivated seasonal influenza vaccines for human use contain two influenza A virus subtypes, H1N1 and H3N2, along with a representative influenza type B virus. These trivalent influenza vaccines (TIV) provide protection primarily by eliciting the production of protective antibodies to hemagglutinin (HA), the primary viral antigenic component of influenza vaccines. The TIV must meet regulatory standards, and formulation of the final product requires a minimum amount of 15 (mu)g of HA from each subtype (H1, H3, and B) in each 0.5-mL dose. Currently, regulatory potency requirements for TIV require HA quantification based on the single radial immunodiffusion (SRID) assay, which is time consuming, laborious, and requires production of large quantities of reagents globally. Therefore, it is extremely important that additional approaches are available to rapidly produce and administer new vaccines. Considerable efforts are being made within the federal government to improve the quality and reduce the time to formulate TIVs to support vaccine manufacturing and release of the final product in a timely fashion to protect public health. Here, we describe how mass spectrometry-based methods can be used to update current regulatory practices.