Antibody injections are a extremely fascinating therapy for folks with persistent ailments reminiscent of most cancers, psoriasis, Crohn’s illness and arthritis. And lately, antibodies have been within the information as a promising therapy for extreme instances of COVID-19.
However the expensive, time-consuming manufacturing course of to provide antibodies prevents these therapies from being accessible to most sufferers.
Andrew Zydney, Bayard D. Kunkle Chair and professor of chemical engineering at Penn State, has recognized a brand new methodology to fabricate antibodies, which might drive down the manufacturing value. His analysis outcomes have been lately revealed in Biotechnology Progress.
“If you happen to take a look at the highest 10 best-selling medicines, by annual gross sales, eight are within the class of monoclonal antibodies,” Zydney mentioned. “And yearly, people and insurance coverage corporations spend upwards of $100 billion on antibodies, with prices to deal with a single affected person typically exceeding $50,000. There stays an enormous unmet want for these merchandise in treating a rising vary of ailments.”
Generally known as precipitation, Zydney’s new protein purification course of entails including zinc chloride and polyethylene glycol, a water-soluble polymer, to an answer containing the antibody. This causes the antibody to precipitate in order that the impurities could be washed away.
Although the precipitation course of has been used for 70 years in blood plasma processing, it has by no means been used for the business manufacturing of antibodies, based on Zydney.
“To precipitate means ‘to return out’ of an answer in a stable type,” he mentioned. “For instance, while you put salt in heat water, it dissolves. However for those who put quite a lot of salt into chilly water, a few of that salt will stay as stable crystals. In the identical approach, proteins would usually dissolve in an answer, however you will discover sure situations the place they arrive out as stable.”
Zydney defined that the zinc chloride utilized in precipitation is an easy salt, making it less expensive than different purification strategies. It additionally saves time, as it’s doable to yield giant portions of proteins briefly durations of time.
Presently, antibodies are produced utilizing a course of referred to as Protein A affinity chromatography, the place the antibody binds to Protein A, which is immobilized in a chromatography column. The impurities could be washed away from the certain antibody, after which the pH degree is adjusted to get better the purified antibody product. A single Protein A chromatography column can value greater than $10 million.
“That is only one step within the present manufacturing course of, and it’s what makes antibody manufacturing so costly,” Zydney mentioned. “The entire main biotechnology corporations are large gamers on this area.”
The precipitation course of eliminates the necessity for the expensive chromatography course of, as antibodies are purified straight from the answer by filtration via hole fiber membranes.
“What we do in our analysis group is comparatively small scale,” He mentioned. “However the precipitation course of has the potential to be simply scaled up, probably enabling biopharmaceutical corporations to provide lower-cost antibodies for the sufferers who want them.”
Todd Przybycien, professor of chemical and organic engineering at Rensselaer Polytechnic Institute, contributed to this analysis.
The Nationwide Science Basis’s Grant Alternatives for Educational Liaison with Business (GOALI) program supported this work. As a part of the grant, Zydney’s analysis group collaborated with Boehringer Ingelheim, a serious biopharmaceutical firm that produces antibodies.