Research at Clemson University that seeks to help lower the cost of expensive drugs has received a $6 million boost from the National Science Foundation’s Established Program to Stimulate Competitive Research, or EPSCoR.
Clemson bioengineering professor Sarah Harcum leads a team of researchers seeking better ways of engineering Chinese hamster ovary cells, which are used to manufacture more than half of biopharmaceuticals, according to a news release. Products from these cells represent more than $70 billion in sales each year and include drugs for Crohn’s disease, severe anemia, breast cancer and multiple sclerosis.
The focus for Harcum and her team will be on the Chinese hamster ovary “cell line,” which is developed from a single cell culture and starts with uniform genetic composition that would ideally remain unchanged. But that genetic composition drifts as the cells reproduce, and they become less effective at creating the drug they have been engineered to create. As a result, manufacturing becomes more expensive, Harcum said.
“We expect by the end of the study we will have identified some genes that cause the instability,” she said, in the release. “What would be even better is if we can prove by modifying those genes we can make a genome that is more stable. With success, the Chinese hamster ovary cell line will stay more stable during the manufacturing. We hope to get that drift to be reduced-- that’s the ultimate goal.”
The research addresses one of the toughest challenges in manufacturing biopharmaceuticals, the release said. Biopharmaceuticals are different from more conventional drugs, such as ibuprofen and acetaminophen, which are based on what researchers call “small molecules” and are relatively easy to manufacture.
Biopharmaceuticals, however, are 1,000 times larger than the small molecules and have structures that are more complicated. While biopharmaceuticals can treat disease that small-molecule drugs cannot, manufacturing these large-molecule drugs are more difficult. They require more monitoring, control and analysis throughout the manufacturing process.