Column-to-column packing variation of disposable pre-packed columns for protein chromatography

摘要

Highlights?The column-to-column variation mainly affects column efficiency, not the retention.?The column efficiency varies between 10 and 15% for equally packed columns.?The column-to-column variation is not explained by the packing density.?The column-to-column variation is explained by heterogeneity in packing structure.?Measurement precision of the workstation was included in the evaluation.AbstractIn the biopharmaceutical industry, pre-packed columns are the standard for process development, but they must be qualified before use in experimental studies to confirm the required performance of the packed bed. Column qualification is commonly done by pulse response experiments and depends highly on the experimental testing conditions. Additionally, the peak analysis method, the variation in the