Without changing the basic chemistry of the separation process, BioSMB^™ technology allows a significant gain in specific productivity (in terms of grams of product produced per liter of chromatography media volume per unit time) and in buffer consumption. The impact of these features, however, can be different for each application.

The descriptions below provide an illustration of the value proposition of this technology based on four case studies.

Case 1: Protein A Chromatography for Capture

Several large companies have evaluated the BioSMB^™ technology for reducing the costs associated with Protein A chromatography media in clinical manufacturing. These studies used the Tarpon BioSMB Process Development system.

Challenge: Each year, companies with 12 or more clinical campaigns per year may require 50 to 80 L of Protein A chromatography media for each clinical campaign. As a result, companies may spend up to 1 million dollars per campaign on Protein A chromatographic media alone, thus this cost is the dominant operating expense by far.

Solution: By converting a batch capture process to a BioSMB process, it was shown that a savings of approximately $250K- $300K / per clinical campaign or $3 million dollars per year could be realized using BioSMB^™ technology instead of batch chromatography in clinical operations.

In addition, these demonstrations also showed that with BioSMB technology adding disposables and fine tuning the process parameters enables the purification of monoclonal antibodies with titers anywhere between 1 and 10 gm/L using the same equipment and column size. Particularly in clinical manufacturing where titers vary from project to project, this allows for increased operational flexibility and facility utilization.

Result: Product quality attributes were monitored using the customer's assays. A comparison of impurity profiles demonstrated that BioSMB^™ technology was in all cases equivalent or slightly better than the batch process, all while yielding specific productivity numbers 6-8 X that of batch.

Case 2: Disposable Vaccine Manufacturing

An innovative vaccine company has developed a manufacturing platform process for their virus like particles (VLP) based vaccines. The company philosophy was to create a fully disposable manufacturing process that could be easily employed anywhere around the world. This would allow the company to meet the rapid response that is required for addressing pandemic viruses.

Challenge: To create a platform process using two chromatographic steps, one of which was size exclusion chromatography (SEC). SEC is known to be a useful methodology for binary fractionation but is not particularly easy to scale due to flow rate and capacity constraints.

Solution: By using BioSMB technology, the company was able to purify the vaccines with as little as 10% of the media used in batch mode, which corresponded to 8 – 15 times higher specific productivity and 50% of the buffers. These savings would enable the company to create a viable fully disposable vaccine manufacturing process.

Results: In all four cases, two chromatography steps for two vaccine products, the yield and purity were similar or better than the batch process.

Case 3: Facility Fit. Polishing of Monoclonal Antibody

A large biopharmaceutical company evaluated the BioSMB^™ technology for removing aggregates from a fusion protein, a form of antibody therapeutic.

Challenge: The batch process would have, if implemented on large scale, required either a larger column than available ( >3+ M diameter) and 30 thousand liters of buffer or longer processing times than could be tolerated.

Solution: The project demonstrated that BioSMB^™ technology would allow them to purify the same amount of product with either 1/3 of the media or in 1/3 of the processing time.

Results: The BioSMB^™ technology delivered a higher purity at the same yield or a higher yield at the same purity as the batch process. Most importantly, BioSMB technology provides a way to 'shrink' the existing process to one that can fit into an existing facility in terms of both square footage and buffer tank hold tank capacity.