Column Chromatography Process Improvements

Embracing certain changes in pharmaceutical manufacturing processes has the potential to push companies well ahead of their competitors.  Downstream processing is difficult to make changes to, and yet changes to equipment, such as column chromatography, have the highest potential for saving money and expediting manufacturing.  However, expertise in this field is hard to come by.  

HA Large Scale Column Chromatography

We Put Our Cards On The Table - And Share Them

Our consultants are some of the few true experts in the large-scale column chromatography field.  We believe in sharing our knowledge and constantly expanding it, not holding our cards close to our chests.  Therefore, as part of our consulting process, we include training of our clients’ personnel with our experts.

They also have a proven track record of training our clients’ personnel in areas like column packing, preventative maintenance, and optimizing equipment and material utilization within large-scale manufacturing facilities.

Sample Chromatography Project Performed By Our Team

  • Significantly improved the Overall Equipment Effectiveness (OEE) on an existing over 10K scale monoclonal antibody (mAb) purification process.  We did this by;
    • Reducing column packing time by 70%
    • Increasing the number of operators able to properly and repeatably pack the column.
    • Eliminating costly rework by addressing O-ring failures in the slurry nozzles.
    • Introducing a variable height chromatography column which eliminated the rework inherent in the iterative approach in fixed height beds with their tighter tolerances.
    • Making the packing process and overall process easier.
  • Providing training, which;
    • Increased the number of operators able to properly pack the column.
    • Enabled personnel to confidently and accurately test the column packing to ensure efficient and repeatable recovery.
    • Facilitated operators to properly perform and interpret HETP and asymmetry calculations.
    • Ensured correct/proper preventive maintenance procedures.  This not only reduces the chance of rework or scrap of a production run, but it also reduces the number of CAPAs.
    • Was a critical part of the success of this project.

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