Chromatography

Use of pre-packed chromatography columns for downstream bioprocessing is increasing rapidly fuelled by requirements for greater productivity and efficiency, and the move toward single-use and flexible facilities.

Use of pre-packed columns in downstream chromatography has increased in response to the needs of multi-product facilities and initiatives focused on reducing change over time.   In particular, adopters of pre-packed columns have realized the following benefits:

• Quick and easy set-up
• Rapid change over (no column packing, unpacking, or cleaning validation)
• Operational flexibility for multi-product facilities
• Reduced capital expense
• Reduced operational cost
• Eliminate column packing issues

Replacing traditional self-packed glass or stainless steel columns, pre-packed columns are packed by experts in state of the art facilities and are delivered ready to use for GMP processing. 

The ability of pre-packed column suppliers to focus their operations on column packing results in more consistently packed columns over time.  This allows a bioprocessing facility to outsource column packing, a non-value added step for making therapeutic proteins, and no longer worry about column packing issues.   This transfer of operational risk helps adopters of pre-packed columns to maintain leaner operations and focus on the most critical aspects of making and purifying therapeutic proteins. 

As the industry evolves to incorporate continuous processing, pre-packed columns are a perfect fit for multi-column chromatography.  Banks of multiple pre-packed columns can be delivered ready to run eliminating the need for multiple self-packed columns.  In addition, the potential for pre-packed columns to be gamma sterilized provides a compelling value proposition for companies looking to implement multi-column chromatography.  

While perfusion, or upstream continuous bioprocessing, has been in use since the 1980s, batch chromatography is still the dominant practice in downstream affinity capture. To integrate with upstream processes already in continuous mode and to take advantage of the benefits of continuous processing, many companies are starting to use multi-column chromatography systems.

In multi-column chromatography,  a complex mixture is loaded into the system and goes through a series of washing, elution, regeneration, and equilibration steps. These procedures repeat in subsequent, parallel columns.  The size of the continuous chromatography column is greatly reduced, but with the same or better capacity and volumetric productivity as a typical batch column. 

Benefits of multi-column chromatography include:

• Continuous processing from fermentation to purification
• Better facility utilization, no downtime
• Decrease in consumption of resin, buffers and solvents
• Significantly reduced facility footprint by reducing equipment size
• Potential operational savings if can introduce more automation