Antibody injection is a very useful treatment for people with breast diseases such as cancer, psoriasis, Crohn’s disease and arthritis. And recently, antibodies have been in the news as a promising treatment for severe cases of COVID-19.
But the costly, time-consuming manufacturing process for producing antibodies prevents these treatments from being accessible to most patients.
Andrew Zydney, Chairman of Bayard D. Kunkle and professor of chemical engineering at Penn State, has identified a new way to produce antibodies, which could reduce the cost of production. His research findings were published in Advances in Biotechnology.
If you look at the top 10 best-selling medications, with annual sales, there are eight in the category of monoclonal antibodies. And every year, individuals and insurance companies spend more than $ 100 billion on antibodies, with costs for treating one patient often exceeding $ 50,000. These results are still in great unmet need in the treatment of a growing range of diseases. “
Andrew Zydney, Chairman of Bayard D. Kunkle and Professor of Chemical Engineering, Penn State
Known as precipitation, Zydney’s new protein cleaning process involves the addition of zinc chloride and polyethylene glycol, a water-soluble polymer, to a solution containing the antibody. This causes the antibody to shut down until the inconsistencies are washed away.
Although the spraying process has been used for 70 years in blood plasma processing, it has never been used for commercial production of antibodies, according to Zydney.
“Blocking means ‘coming out’ of a solution in solid form,” he said. “For example, when you put salt in warm water, it melts. But if you add a lot of salt to cold water, some of that salt will remain as hard crystals. Similarly, proteins would normally dissolve in solution. but you get special situations where they come out as hard stuff. “
Zydney explained that zinc chloride is a simple salt used in spraying, making it much cheaper than other cleaning methods. It also saves time, as it is possible to extract large amounts of protein in a short time.
Currently, antibodies are extracted using a process called Protein A chromatography, where the antibody binds to Protein A, which is transferred into a chromatography column. The inconsistencies can be washed away from the bound antibody, after which the pH level is adjusted to regain a purified antibody product. One column A chromatography column can cost over $ 10 million.
“That’s just one step in the conventional manufacturing process, and that’s what makes antibody manufacturing so expensive,” Zydney said. “Every major biotechnology company is a big player in this space.”
The spraying process eliminates the need for the costly chromatography process, as antibodies are cleared directly from the solution by filtration through a hollow fiber membrane.
“What we do in our research group is relatively small,” he said. “But the spraying process has the potential to be easily scaled up, enabling biopharmaceutical companies to have antibodies at a lower price. to produce for the patients who need them. “
Li, Z., et al. (2021) Improved filtration performance by the use of feed and bleed preparations for antibody primer clearance. Advances in Biotechnology. doi.org/10.1002/btpr.3082.