Disposable Chromatography

When scientists bring up the subject of liquid chromatography (LC), complexity and high cost are two things that immediately come to the mind. While LC has proven to be a very useful analytical technique in the laboratory, as well as being advantageous in selected preparative and production-scale applications, it is an extremely involved technique that is generally avoided unless a clear argument can be made as to its advantage. While the market for single-use chromatography is quite small and has very few vendors, it has considerable potential within the purification chromatography market.

LC generally requires high pressure, which necessitates robust pumps, columns, connectors and other hardware that can withstand high pressure, significantly increasing the cost of a system. In addition, traditional LC requires the cleaning and validation of the system between runs, adding additional costs, as well as time. On a larger scale, such as in preparative and production-scale processes, such costs are magnified. If the time, cost of cleaning and validation, or the cost of equipment could be reduced or eliminated, purification chromatography would be a more cost-effective separation method. However, the biggest potential problem for disposable purification chromatography is reliably consistent performance of successive columns or membranes.

Recent product introductions have now made disposable chromatography a reality. All single-use production chromatography technologies allow for much lower pressure systems, making them far more economical than standard purification chromatography methods. Some vendors of single-use chromatography claim as much as an 80% reduction in end-user costs are possible.

Disposable chromatography is focused on the production of biopharmaceuticals, which is where conventional purification chromatography is most heavily used. Because of the need to isolate a single compound from the complex biological broths, chromatography is often a cost-effective step. A unique advantage of disposable chromatography to biopharmaceuticals is the elimination of any potential carryover or buildup of toxins and other contaminants from run to run. Potential applications for disposable chromatography include the production of nutraceuticals or water purification, for which conventional chromatography technology is too expensive.

Most of the current disposable chromatography products on the market are based on membrane chromatography, a market in which Sartorius AG is the leader and Pall also participates. The disposable portion of a system varies by product line. Both Pall and Sartorius offer disposable membrane chromatography capsules. The most recent major entrant to the market is Upfront Chromatography A/S of Denmark, which has combined expanded bed absorption with disposability. The current market is well over $10 million annually, but should see strong double-digit growth as this relatively new niche develops.

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