Antibody-independent surface plasmon resonance assays for influenza vaccine quality control

Abstract

Surface plasmon resonance (SPR)-based biosensors have emerged as a powerful platform for bioprocess monitoring due to their ability to detect biointeractions in real time, without the need for labeling. Paramount for the development of a robust detection platform is the immobilization of a ligand with high specificity and affinity for the in-solution species of interest. Following the 2009 H1N1 pandemic, much effort has been made toward the development of quality control platforms for influenza A vaccine productions, many of which have employed SPR for detection. Due to the rapid antigenic drift of influenza’s principal surface protein, hemagglutinin, antibodies used for immunoassays need to be produced seasonally. The production of these antibodies represents a 6–8-week delay in immunoassay and, thus, vaccine availability. This review focuses on SPR-based assays that do not rely on anti-HA antibodies for the detection, characterization, and quantification of influenza A in bioproductions and biological samples. Key points • The single radial immunodiffusion assay (SRID) has been the gold standard for the quantification of influenza vaccines since 1979. Due to antigenic drift of influenza’s hemagglutinin protein, new antibody reagents for the SRID assay must be produced each year, requiring 6–8 weeks. The resulting delay in immunoassay availability is a major bottleneck in the influenza vaccine pipeline. This review highlights ligand options for the detection and quantification of influenza viruses using surface plasmon resonance biosensors.

Analysing the Potency of a Seasonal Influenza Vaccine Using Reference Antisera from Heterologous Strains

“…There are alternative approaches to SRD investigated for potency determination, including the antibody-dependent capture detection ELISA, which our group has previously published on [ 3 ]. Antibody-independent assays have also been described, such as the surface plasmon resonance assay [ 4 ] and reversed-phase high-performance liquid chromatography [ 5 ]. While these have been proposed for potency determination, the SRD assay remains the standard which is recognised and accepted by regulatory authorities for potency testing and the release to market of inactivated vaccines.…”