Utilisation of monoclonal antibodies in the single radial immunodiffusion assay to determine potency and stability for seasonal and pandemic influenza vaccines.

ABSTRACT:

Introduction

Following manufacture, influenza vaccines are required to undergo potency testing as part of the release process to market. The single radial immunodiffusion (SRID) assay is currently the compendial standard for determining the antigen potency and stability of protein-based influenza vaccines. This assay relies on polyclonal antibodies from animal serum to bind protein antigens in a gel, resulting in a visible precipitin ring. The diameter of this ring is then compared to a calibrated standard to quantify potency. However, the production of polyclonal antiserum introduces delays, impacting the timely release of both seasonal and pandemic vaccines. There is a need for alternative methods that can expedite vaccine release without compromising accuracy or reliability.

SUBMITTER: Bodle J 

PROVIDER: S-EPMC12665921 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature