It's been circulating in the news recently that antibody injection which is used as a treatment for people with chronic diseases like cancer, psoriasis, arthritis, and Crohn's disease; is also a rising treatment for severe cases of COVID-19. But, the manufacturing procedure for these antibodies is time-consuming and costly which hinders the production to most patients.
In recent research published in Biotechnology Progress conducted by Andrew Zydney, Bayard D. Kunkle Chair, and professor of chemical engineering at Penn State, a new method in manufacturing antibodies was established which could drive down the cost for production.
Applying the process of conversion of a chemical substance into a solid from a solution by converting the substance into an insoluble form or a supersaturated solution, known as precipitation causes the antibody to precipitate so that the impurities can be washed away. This is Zydney's new protein purification process that involves adding zinc chloride and polyethylene glycol, a water-soluble polymer, to a solution containing the antibody.
Zydney clarified that the zinc chloride utilized in precipitation is a basic salt, making it a lot less expensive than other sanitization techniques. It likewise saves time, as it is feasible to yield huge amounts of proteins in brief timeframes.
Currently, antibodies are produced using a process called Protein A affinity chromatography, where the antibody binds to Protein A, which is immobilized in a chromatography column. The impurities can be washed away from the bound antibody, after which the pH level is adjusted to recover the purified antibody product. A single Protein A chromatography column can cost more than $10 million.
"If you look at the top 10 best-selling medications, by annual sales, eight are in the category of monoclonal antibodies," Zydney said. "And every year, individuals and insurance companies spend upwards of $100 billion on antibodies, with costs to treat a single patient often exceeding $50,000. There remains a huge unmet need for these products in treating a growing range of diseases."
"That is just one step in the current manufacturing process, and it is what makes antibody manufacturing so expensive," Zydney said. "All of the major biotechnology companies are big players in this space."
"What we do in our research group is relatively small scale," He said. "But the precipitation process has the potential to be easily scaled up, potentially enabling biopharmaceutical companies to produce lower-cost antibodies for the patients who need them."
Todd Przybycien, professor of chemical and biological engineering at Rensselaer Polytechnic Institute, contributed to this research.
The National Science Foundation's Grant Opportunities for Academic Liaison with Industry (GOALI) program upheld this work. As a component of the award, Zydney's exploration bunch teamed up with Boehringer Ingelheim, a significant biopharmaceutical organization that produces antibodies.