Revolutionizing the Manufacture of Medicine and More

November 30, 2021

Making new drugs, vaccines and gene therapy can take up to a decade or longer, and cost hundreds of millions of dollars or more. The process is complex and it requires many steps to go from conception to market. And a new platform from ChromaTan, a startup with roots in Happy Valley, is poised to change a significant part of that process, streamlining chromatography and enhancing efficiencies while decreasing costs. 

“We have a very unique platform that’s especially relevant nowadays,” notes Oleg Shinkazh, CEO and founder of ChromaTan. “Finally, after all this time, we’re going to be launching our platform to market next year. We had the market launch delayed because of COVID.”

ChromaTan was born in 2010, after Shinkazh witnessed significant problems within biomanufacturing. “There were many cost and processing inefficiencies at the time, and I was lucky enough to come up with an elegant solution,” he says.

“Our process eliminated the columns,” says Shinkazh. “We turned it from a batch operation to a continuous operation. Instead of the resin being packed, it’s rapidly cycled like a conveyor belt, while all the chromatographic operations are performed continuously on a moving slurry — like a conveyor belt.”

Once Shinkazh had that solution, he patented it on his own time and started planning his next steps. But what he discovered was the catch-22 situation that so many entrepreneurs come up against: You need money to generate data and you need data to raise money.

To navigate his way through that catch-22, Shinkazh partnered with Penn State University and the strong relationships he had already established there, including with Andrew Zydney, now Distinguished Professor of Chemical Engineering. Together, the two teamed up and were able to generate critical initial data in Zydney’s lab. 

“We then used that data to co-publish and to apply for grants from the National Institutes of Health and, in parallel, I applied for funding from Ben Franklin Technology Partners. 

When I got the NIH grant, it was matched by Ben Franklin’s investment and I incubated the company for a while in the State College area,” Shinkazh explains.  

With the initial funding secure, Shinkazh hired his first employees. From there, the fledgling startup got to work raising additional funding from investors and other grants. 

A Complex Process In Need of Enhanced Efficiency

The way a lot of modern drugs are made is in bioreactors via gene programming. You basically have a genetically-engineered cell that’s programmed to produce a certain protein. Those cells are cultured and grown in a bioreactor. As you’re growing them, they make the product you want. At the end of the process, you end up with a complex “soup” in the bioreactor. That soup is made up of cells, cell debris, DNA, RNA, contaminating proteins and all kinds of things you don’t need. 

As Shinkazh explains, “Out of that soup, one product has to be extracted that you need. And you need to be able to make it 99.9% pure so it becomes a medicine.”

It’s a very complicated downstream process that’s made up of many operations. Several of those operations fall under the umbrella of chromatography, which takes that molecule of interest and, based on some chemical properties, affinities or molecular charge, binds the molecule of interest while letting everything else flow through. Then the chemistry gets changed up a bit and the molecule of interest can be recovered. 

“It’s essential for the ecosphere to have the kind of support Ben Franklin provides,” notes Shinkazh. “In the early stages, companies really struggle to raise money. It’s very difficult and risky for entrepreneurs, especially those who don’t have a business background. I didn’t have a business background and had to learn, which is yet another way Ben Franklin helped me get my start.”

The process is currently done within cylindrical columns packed with tiny resin particles that capture the molecules of interest. The process is very inefficient and expensive.

“Our process eliminated the columns,” says Shinkazh. “We turned it from a batch operation to a continuous operation. Instead of the resin being packed, it’s rapidly cycled like a conveyor belt, while all the chromatographic operations are performed continuously on a moving slurry — like a conveyor belt.”

This makes the process much more efficient. ChromaTan’s platform uses about 20% of the resin volume that’s needed in a traditional column. It’s also much faster. 

Shinkazh explains, “The platform we’re developing can make a significant impact, increasing process efficiencies and decreasing the cost of manufacturing life-saving therapies and drugs, including expensive biologics such as the COVID antibody cocktails and drugs like cancer medicines, autoimmune disease drugs and vaccines. We’re also getting into the gene therapy market as well, and we’re really excited about that.”

A Ben Franklin Success Story in State College and Beyond

From inception to ChromaTan’s launch, it took more than two years. Shinkazh opened his location in Innovation Park in 2012, a move that may have been impossible without the help of Ben Franklin Technology Partners. 

“We are so grateful for Ben Franklin — they do such important work,” says Shinkazh. “Without them it would have been really, really tough. They really helped us so much. There are great people, not just in the State College and central branch, but also in other branches as well. When we moved to Philadelphia we raised money from the Southeast Ben Franklin and they have some great folks there, too.”

The first investment from Ben Franklin was $150,000 and, over the years, Ben Franklin invested an additional $500,000 into the company. The economic development program didn’t just help with funding. It also helped Shinkazh secure space in Innovation Park and it introduced him to local investors and helped him with networking. 

“It’s essential for the ecosphere to have the kind of support Ben Franklin provides,” notes Shinkazh. “In the early stages, companies really struggle to raise money. It’s very difficult and risky for entrepreneurs, especially those who don’t have a business background. I didn’t have a business background and had to learn, which is yet another way Ben Franklin helped me get my start.”

To learn more about ChromaTan, visit https://www.chromatan.com/ 

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