Disposable Membrane Chromatography

By Jeff Mora, Andrew Sinclair, Noushin Delmdahl, and Uwe Gottschalk

Disposable devices for unit operations in bioprocessing have been commonplace for some time. Additionally, support systems for each unit operation have also become disposable. They include aseptic bags for buffer and product storage and filters to ensure sterility. The most common disposable devices for unit operations are filters used to clarify harvests and protect columns, virus retentive filters, sterilizing-grade filters for fill and finish, and in some cases crossflow filters for product concentration and buffer exchange.

The simplest reason behind this development is that disposables eliminate cleaning validation for stainless steel housings and vessels and streamline development and/or scaleup. FDA cleaning regulations require cleaning, maintenance, and sanitization of equipment and utensils at appropriate intervals to prevent malfunctions or contamination. Furthermore, such cleaning needs to be validated. Eliminating cleaning validation not only reduces costs, but it also decreases the time it takes to get to a final process. Most validation projects take months or even years to complete, significantly delaying process finalization. Moreover, because disposable devices are modular and available in numerous sizes, scaling up a process is often just a matter of increasing device size by whatever factor is necessary.