Design and Manufacture of cGMP, Scalable Expanded Bed Adsorption Chromatography Columns

Expanded Bed Adsorption chromatography (EBA) allows clarification and direct product capture in one unit operation.

Upflow conditions achieve a fluidized bed, twice the volume of the settled bed. Crude, high cell density and highly-viscous feed streams such as cell culture, foods and plasma are injected upflow.

Cells, cell debris, host cell proteins (HCP’s) and DNA leave the expanded bed, whilst the target molecule is bound to the media.

In order to facilitate a renaissance in EBA, columns built to current Good Manufacturing Practice (cGMP) standards had to be designed, be scalable, and be both feasible and economic to manufacture.

The user requirement specifications brought a number of design and manufacturing challenges to overcome: