Due to the complexity of processes used to produce vaccine clinical candidates, a multitude of analytical methods are required to characterize the dose, purity and potency of samples throughout the process, as well as the final product. A toolbox of automated assays have been developed to support the needs of the process, and can be divided into biochemical and immunological categories. The biochemical methods encompass assays to quantitate protein, nucleic acids, excipients and process residuals, while  immunological methods, in particular ELISAs, are used to quantitate product mass/potency and process residuals. A platform has been established using Tecan liquid handling systems to provide efficient, high-throughput methods to facilitate decreased cycle time in vaccine process development.

Vaccine process monitoring toolbox: An overview of automated biochemical and immunological methods to support vaccine process development

244th National Meeting (2012)

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