The integrity of packed bed chromatography columns is commonly evaluated to determine if a column is acceptable to use for processing a drug product intermediate. The integrity test is performed under conditions in which the packing factor in van Deemter’s equation is maximized and the quality of the packed bed is assessed by calculating the Asymmetry (As) and Height Equivalent to a Theoretical Plate (HETP). This same approach is used irrespective of chromatography type, although the packing factor is negligible in applications such as Protein A affinity. During process development, lab scale Protein A columns are rarely evaluated for HETP or As, but a failure of either one of these values during large scale column qualification leads to resource intensive repacking operations. In this work we evaluated the critical process parameters (capacity, yield, purity, elution pool volume) for Protein A columns having a broad range of As and HETP including some outside the range of typical acceptable values. The output of this work could be leveraged to broaden the acceptance criteria for Protein A column qualification and to reduce the need to repack process-scale columns.

Evaluating the correlation between packing quality and process performance in protein A chromatography

253rd National Meeting (2017)

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