Apr 04, 2017 02:42PM
● By Makayla Gay
By Vincent Harris
Photograph By Vincent Harris
We’ve all seen them: The ads for medications that seem to have more side effects than actual effects. Seemingly every drug has a litany of possible negative consequences to go along with whatever help they’re supposed to give. Do you ever wonder why these side effects exist or where they come from? Drs. Scott Husson and Jinxiang Zhou can tell you at least one of the common causes: impurities.
Husson, a professor in the Department of Chemical and Biomolecular Engineering at Clemson University, and Zhou, one of his Ph.D. students, have spent nearly four years working on technology to help pharmaceutical companies filter the impurities from their new drugs, and they’ve done so as a company called Purilogics.
Dr. Husson was working with another student on technology to create biologic drugs, or therapies that are produced by living systems, and when that student decided not to carry on the research, Husson approached Zhou with proposition before the young man earned his doctorate.
“I asked him what his aspirations were for the future, and he indicated he would be interested in starting a company at some point and being an entrepreneur,” Husson says. “And as he was moving closer to graduation, I had been contemplating Purilogics. I didn’t have the name, but the technology had been developed, and I simply asked if it was something he’d be interested in pursuing. And we started the company in 2013.”
The technology is both revolutionary and simple.
“The specific compounds in a drug are called biologics, and that means they are produced with biological processes,” Husson says. “Because of the way they’re produced, they’re inherently impure, and our technology is used to remove impurities. The product (called the Puri disposable membrane) actually looks very much like paper, because it’s made out of cellulose, the same material you’d find in paper. But it has pores. So we pack this product into a simple column and flow the drug solution through the filter, and it’s designed to catch the protein or whatever biologic we’re targeting.”
The process is applied mainly to drugs that treat cancer, autoimmune diseases and some cardiovascular diseases. Husson says the side effects of these drugs can be drastically reduced through purification.
“There are virus particles that are inherently part of the process of making the drugs,” he says. “The FDA has very stringent regulations on the impurities that can be in a given formulation, and that’s to prevent the immunogenic response.”
An immunogenic response is a reaction by the body to an antigen in which antibodies are produced. This can cause an array of adverse effects on the body, from nausea to insomnia to a host of more serious responses.
For Husson and Zhou, the hard part wasn’t developing the technology, though that did take a lot of work; instead, it was figuring out who to sell it to and how to make them aware of what Purilogics does.
“During the process of starting the business, we spent a lot of time talking to potential customers,” Zhou says. “We spoke with over 140 people in the pharmaceutical industry to find out what their purification problems were.”
One of the things that Scott and Zhou learned early was to concentrate on drugs that are in the development and testing stages, because introducing a new purification process to an established medication was a non-starter.
“We didn’t appreciate when we started that when you have an established drug that might be a billion-dollar-a-year-product, you also have an FDA-approved method of purifying it, “ Scott says. “So if there’s a change in that process with a new product, the company would have to re-file all their regulatory paperwork in order to use it.”
“So there’s a lot of resistance to doing that,” he adds with a laugh.
The decision was quickly made to stick to drugs in the clinical testing phase, but there’s no shortage of potential customers. Husson says that in the United States alone, there are currently around 900 drugs in that phase, treating more than 100 disease types. However, Zhou is quick to add that it’s not quite as simple as applying the Puri disposable membrane to one drug.
“To get one drug to the market, you’re starting with many,” he says. “So it’s not necessarily used for the drug that’s going to get approved because nobody knows what that is. It doesn’t make very much sense to put energy and time into focusing on one particular drug. It’s up to the customers to tell us how we can help.”
The issue now for Purilogics is growth. They’re funded largely through a grant from the National Institutes of Health, with additional help from SC Launch and SC Bio, an organization designed to advance the life science industry. And though they’ve been working with Charleston Pharma, LLC and Bristol-Meyers Squibb, there’s still a lot of room to expand.
“We’re a very early stage company,” Scott says. “So we’re still forming bonds with particular pharma companies and working to get them to evaluate our products. It would really be nice to have investment from outside organizations. For us to grow we would need investment from beyond the grants.”
For more information, visit www.purilogics.com