Reliable analytical tools are valuable for economical process development, production, and batch release of vaccines. The current method recommended by the European Pharmacopoeia and WHO for determination of influenza virus titer ¬ single radial immunodiffusion assay (SRID) is straightforward and easy, but leaves plenty of room for improvement when it comes to assay variability and speed of analysis. In addition to having low sensitivity and precision, the method is both time-consuming and quite labor-intensive. In this study a Biacore™ assay based on surface plasmon resonance-technology (SPR) was developed to achieve improved performance for determining the concentration of the three human influenza virus types (A/H1N1, A/H3N2 and B) from cell-derived vaccine process development. Robustness, precision, and detection range were investigated and compared to SRID analysis. In addition, with no cross reactivity between the different influenza virus subtypes, it was possible to introduce a single, combined assay for batch release of influenza vaccine. Results showed the SPR-based assay to have higher sensitivity (detection range 0.5 µg/ml to 10 µg/ml), higher precision and significantly shorter analysis and hands-on time compared with SRID.

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Camilla Estmernilsson
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