The optimization of IEX separations poses a multi-factorial challenge since the selectivity is determined by many parameters. In order to cope with the time and cost constraints associated with process development several screening approaches at small scale exist.In this work the impact of a 2-propanol/salt elution buffer system on the purification of recombinant insulin in an anion exchange capture step using Fractogel EMD DEAE (M) has been investigated. Initial trials with lab scale columns showed that the presence of an organic modifier was required for good selectivity. To assess the full potential of the IPA/salt system for process improvements and to avoid the greater experimental effort of column trials a batch assay approach in MTP format was employed. The selectivity of the IPA/salt system was studied by measuring the distribution of insulin and impurities between liquid and stationary phase.This paper highlights technical aspects associated with the implementation of a MTP screening assay and gives insight how batch assay data can be used to predict column results.

Selectivity screening in AEX insulin capture using an IPA/salt elution system

247th National Meeting (2014)

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