Fast, accurate determination of vaccine titre during influenza vaccine manufacture is important in understanding process performance and correctly scaling each process step. Traditionally Single Radial Immunodiffusion (SRID) assays have been used as the ‘gold standard’ but the assay requires very skilled operators to obtain reproducible results and is relatively low throughput. ELISAs have also been used to determine titre but have lower precision and dynamic range. BLI combines the high throughput characteristics of a 96-well plate based ELISA assay in conjunction with improvements in accuracy and repeatability derived from a simpler direct measurement of mass transfer on binding. The assay is based on the binding of the vaccine to polyclonal antibodies that recognise the influenza epitopes presented by the vaccine. The polyclonal antibody is bound to a protein G or protein A derivatised biosensor depending on the animal source of the antibody. This configuration gives increased flexibility by allowing swift changes between vaccines derived from different viral strains by simply binding the paired Antibody for the new strain to a biosensor without the need for derivatisation. Hence the assay is suitable for the rapid changes in the viral strains represented in a vaccine. A robust assay, capable of determining vaccine titre from various process stages has been developed. The assay has been shown to be applicable to both live attenuated and synthetic vaccines.

Influenza vaccine titre determination using Biolayer Interferometry (BLI)

249th National Meeting (2015)

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