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Big Molecules, Fast Purification

Continuous chromatography could be the key to more efficient large-scale production of complex biopharmaceuticals.

Bioprocessing_1Before you start writing us a letter explaining that simulated moving bed (SMB) chromatography was developed more than 40 years ago, let us explain why we included it in our Top 10 Technologies feature.

The rise of biological treatments in medicine — such as vaccines — has created a challenge for pharmaceutical manufacturers, due in part to the higher complexity of the molecules when compared with more common small-molecule drugs. Minute differences in the makeup of these large molecules can have serious negative health effects, creating the need for high-quality processing techniques.

Biopharmaceutical manufacturers are also experiencing an increase in the speed of upstream production techniques as a result of new fermentation and cell culture processes. However, higher output cannot be achieved until the downstream purification processes can keep up.

From Batch to Continuous Process

Traditional batch chromatography plays an important role in the purification of these and other more traditional active pharmaceutical ingredients (APIs), but it relies on a large quantity of expensive solvents, resins and buffers. More importantly, the process is not continuous, making it less than ideal for large-scale industrial production.

This fact has come to the attention of equipment manufacturers over recent years, with a small group of companies launching advanced purification systems based on the well-known SMB chromatography design. Where batch chromatography uses a single linear column, SMB chromatography uses a series of high-pressure columns arranged in a ring formation. The location of the inlet and outlet streams are switched during the Bioprocessing_2process, simulating a moving bed. These systems use much less solvent while operating continuously, producing a higher yield at a much lower operating cost.

Dave Backer, director of business development and marketing at SAFC Pharma, explains why his company is one of the few producing industrial-scale SMB chromatography systems: “We don’t tend to get into areas that a lot of people are already in; we’re looking more for niche capabilities that we can be quite good at, and SMB chromatography is one of those.”

This technology is not the only method available for API purification, Backer adds, “but when it’s the appropriate technology, it works extremely well. For chiral products, it’s a good purification method to use. In the biopharmaceutical space, we have a number of clients who are using it.”

Backer is reluctant to proclaim the revival of SMB chromatography — particularly when newer techniques are under development — but he acknowledges that there is newfound interest. “We’ve seen an uptick in demand, and it’s an important part of our manufacturing capabilities.”

What we can be sure of is that the huge changes occurring in the pharmaceutical industry — namely the types of drugs being made and the outsourcing of manufacturing — will require technology that keeps safety as the number one priority. Whether it comes in the form of cutting-edge research or the re-invention of old technologies is yet to be seen.