Eureka! You’ve just identified a protein active against the disease you’ve been targeting for years.
Now comes the next challenge. How do you keep your new drug in a form that will sustain its consistency through trials-- and then on to the pharmacy shelf and into the patient’s medicine cabinet?
In the past, solving the problem of solubility in protein-based pharmaceuticals, vaccines and therapeutics has been notoriously difficult. It could take entire teams of researchers a year or more. The expensive, time-consuming process often delayed or even derailed promising new candidates for drug development.
However, the solution to the solubility puzzle is becoming much simpler with the help of Soluble Therapeutics’ HSC™ Technology. The high-throughput second viral coefficient determination system launched last fall was developed by Larry DeLucas, PhD, former astronaut and Director of the Center for Biophysical Sciences and Engineering at UAB, and Bill Wilson, PhD, former Chairman of the Chemistry Department at Mississippi State University.
DeLucas and Wilson collaborated for two decades to develop their HSC™ technology before spinning it off for commercial development in 2008 as Soluble Therapeutics.
Chairman and Chief Executive Officer of the Innovation Depot-based company is Joseph N. Garner, PhD, who also teaches molecular and cell biology in the Biotechnology Program at UAB’s School of Health Related Professions.
“Our approach greatly reduces the man hours and expense involved in developing a new drug candidate,” Garner said. “We can often do in a month or so what it might take a year or more if we were using traditional methods, and often at a fifth to a tenth of the cost. This allows the savings to be reallocated to fund other research projects. It may also make it financially feasible to take a second look at a drug candidate that may have been shelved. A lot less protein is required for drug optimization, which also helps the process get past bottlenecks.”
Soluble Therapeutics typically works with antibodies, enzymes, cell surface proteins, membrane- bound proteins and signaling proteins. The company received more than $1 million in grant funding from the National Institutes of Health, which is being used to advance applications of the technology. Word of the company’s unique capabilities has been getting around, and the phone has been ringing.
“We talked with a company in Europe this morning about a new project they would like us to review. We’ve been doing quite a bit of work with drugs targeting arthritis, heart attacks and cardiovascular problems, as well as vaccines. One project is aimed at developing better forms of insulin for diabetics, and we have also been working with a drug that is biosimilar to Embril.”
The centerpiece of the HSC™ Technology is a self-contained, automated, chromatographic system that does high-throughput, microcapillary, self-interaction chromatography screening using additives and excipients commonly included in protein formulations.
Then the data generated from these screens is analyzed using a predictive algorithm to identify the most promising combinations of additives and excipients likely to increase solubility and the physical stability of proteins.
The next step in the company’s business plan will advance their work from projects at their Birmingham lab to rolling out the HSC™ Technology itself.
“Soon labs all over the world will be able to purchase our technology and instrumentation so they can have it on site and work on projects in their own labs whenever they need it.” Garner said.
In the development process, particularly for protein-based drugs, the technology could very well become standard equipment.
Beyond saving time and money for drug developers and helping scientists doing basic research to work more efficiently, Garner sees the greatest benefit of the technology in what it can mean for patients.
“The economics are important, of course, because that’s what allows drug developers to continue developing new drugs. But for patients dealing with a serious illness like cancer or heart disease, or a community facing a potentially devastating disease outbreak, having a new drug faster, or having it all, can mean life itself. Every month we save can mean a real-life difference for someone in preventing or curing diseases and easing their suffering.”