The BioSMB story begins when I was approached by a biopharmaceutical industry veteran in early 2001 who was looking for a manufacturing solution to decrease the cost of a transgenic drug that had to sell at a price point of several dollars per gram. With our combined industry experience in downstream processing, we quickly realized the potential of applying Simulated Moving Bed technology to the field of biopharmaceuticals to attain the necessary cost savings and efficiency to achieve this ambitious goal.

The challenge was clear from the beginning. Existing equipment was unsuitable for the bioprocess industry due to the cleaning challenges presented by the complex valving of SMB systems. I went on to demonstrate the use of SMB for capturing monoclonal antibodies on Protein A media in a successful proof of concept study; however this program did not proceed due to lack of equipment that is scalable to clinical manufacturing. We continued to explore the technology for bioprocess applications and even tried to work together with a traditional SMB company until it was clear that if we wanted to make SMB practical for biomanufacturing, we would need to design the solution ourselves. In 2006, we began designing a novel, yet simplistically engineered valving scheme based on a repetitive assembly of diaphragm valves. Even though this concept met all of the biopharmaceutical purification requirements, we still considered the equipment rather complex, so we continued to look into strategies to reduce complexity and – most importantly – make the cleaning validation easier.

It wasn't long before we realized that the answer was to make the valve block disposable. With this new concept, we finally felt that we could make continuous chromatography practical for the biopharmaceutical market. Translating the existing system design into one with a fully disposable valve block, which is central to the idea of an economical, fully scalable downsteam processing solution, is the basis for our patented BioSMB technology (Simulated moving bed for biopharmaceutical applications).

When we discovered the company Bioflash Partners LLC with its technology for prepacked disposable columns, we instantly recognized the value forming a new entity to combine this new disposable valving technology, our simulated moving bed expertise, and the disposable format columns to bring a fully disposable flow path to downstream processing. All of the necessary pieces fell together and Tarpon Biosystems was created to bring all of the efficiencies and cost savings of traditional SMB to bioprocess.