Strategic Assay Selection for analytics in high‐throughput process development: Case studies for downstream processing of monoclonal antibodies

During bioprocess development a potentially large number of analytes require measurement. Selection of the best set of analytical methods to deploy can reduce the analytical requirements for process investigation but currently relies on application of heuristics. This paper introduces a generic methodology, Strategic Assay Selection, for screening a large number of analytical methods to produce a subset of analytics that best suit high-throughput studies. The methodology uses a stochastic ranking approach where analytics are ranked based on their holistic performance in a set of criteria. Strategic Assay Selection can be used to help minimizing the impact of analytics in the generation of bottlenecks often encountered during high-throughput process development studies. This is illustrated by using a typical downstream purification process for a monoclonal antibody product. A list of assays is populated for routinely measured analytes across the different units of operation followed by the calculation of their performances in four criteria. The methodology is then applied to select analytics testing for three analytes and the results are analyzed to demonstrate how it can lead to the selection of analytical methods with the most favorable features.