The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines.

ABSTRACT: Assaying the potency of inactivated viral influenza vaccines is performed using single radial immunodiffusion, which is the globally accepted release method for potency. Under conditions of a rapidly emerging pandemic, such as the 2009 H1N1 influenza pandemic, a recognized obstacle in the delivery of vaccines to the public is the time needed for the distribution of calibrated SRID reagents (antisera and antigen standards) to vaccine manufacturers. Previously, we first described a novel streamlined MS-based assay, CombE-IDMS, which does not rely on antisera/antibodies or reference antigens, as a potential rapidly deployable alternate potency method through a comparison with SRID on adjuvanted seasonal quadrivalent vaccine cell-based (aQIVc) materials. In this report, we further demonstrate

SUBMITTER: Donohue MP 

PROVIDER: S-EPMC10747648 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature