High Throughput Screening of Resin Cleaning Procedures

Effective cleaning of chromatography resins is required to prevent fouling and to maximize the number of processing cycles that can be achieved. Optimization of resin cleaning procedures, however, can lead to prohibitive material, labor and time requirements, even when using milliliter scale chromatography columns.

A recently published article describes the use of high throughput (HT) tools to assess cleaning agents for a mAb polishing step utilizing Fractogel® EMD TMAE HiCap (M) anion exchange (AEX) resin. For this particular mAb feed stream, the AEX resin could not be fully restored with traditional NaCl and NaOH cleaning solutions, resulting in a loss of impurity capacity with resin cycling. A range of experimental cleaning agents was evaluated using miniaturized chromatography columns and an automated liquid handling system.

The results identify cleaning agents that may restore resin performance for applications involving fouling species in ion exchange systems. In addition, this study demonstrates the use of HT tools for evaluation of chromatographic cleaning procedures, effectively decreasing material requirements while simultaneously increasing throughput.

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In This Same Issue

• Webinar: High Viscosity UF Formulation for Plasma IgG and mAbs
• Chromatography User Group Meeting a Continued Success