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Application

A Fast and High Precision Influenza Vaccine Potency Assay

Sartorius

Aug 23, 2022

Abstract

Fast and accurate determination of vaccine titre during influenza vaccine manufacture is important in understanding process performance and correctly scaling each process step. Traditionally assays such as Single Radial Immunodiffusion (SRID) and ELISA have their limitations; SRID, though the ‘gold standard’ requires very skilled operators to obtain reproducible results and is relatively low throughput. ELISAs on the other hand, exhibit low precision and dynamic range. The Octet® platform combines the Bio-Layer Interferometry (BLI) technology and high throughput characteristics of a 96-well or higher plate-based platform in conjunction with improvements in accuracy and repeatability derived from a simpler direct measurement to remarkably improve on the vaccine titer process. The assay is based on the binding of the vaccine to polyclonal antibodies that recognize 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 detecting the rapid changes in the viral strains represented in a vaccine. The assay is applicable to both attenuated and synthetic vaccines and can be used for vaccine potency assessment and in various process stages.


Application File

Octet-Fast and High Precision Vaccine Potency Assay.pdf

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