Author Archives: David Wheatley

A Fast and High-Precision Influenza Vaccine Potency Assay

Fast and accurate determination of vaccine titer during manufacturing is important for understanding the performance of a development process and for scaling each process step. Although single radial immunodiffusion (SRID) has been the most commonly used technique for vaccine titer determination, it can be time-consuming and imprecise, requiring up to three days for results. The Pall ForteBio Octet® system offers a simple and direct method for measuring vaccine–antigen–antibody binding, capable of delivering high-precision analysis in as little as three hours.…

Influenza Vaccine Titer Determination Using Bio-Layer Interferometry: An Alternative Technique for More Rapid and Accurate Influenza Vaccine Analysis

Fast, accurate determination of vaccine titer during influenza vaccine manufacture (Figure 1) 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 they require very skilled operators to obtain reproducible results and is relatively low throughput. ELISAs have also been used to determine titer, but they have lower precision and dynamic range. Bio-Layer Interferometry (BLI) combines the high-throughput characteristics of a 96-well- plate–based ELISA…