A recent Notre Dame study conducted by the College of Engineering has developed an improved method of analyzing monoclonal antibodies, which can be used to treat various diseases.
Monoclonal antibodies are often used to treat cancers and arthritis because of their ability to boost the immune system.
Merlin Bruening, a professor of engineering at Notre Dame, worked as principal investigator in this study.
“We’re working on capturing specific monoclonal antibodies that you might be taking for a treatment for some diseases,” Bruening said.
The project has been ongoing for over five years, but the researchers made more significant progress in the last few. Monoclonal antibodies have only recently risen as a viable source of treatment and became especially relevant due to the outbreak of COVID-19. Bruening said their process could be used in analyzing antibodies to treat this virus.
“It’s amazing to me that antibody proteins are now drugs,” Bruening said.
Because monoclonal antibody drugs are harder to produce than other small molecule drugs, they take more time to develop. Junyan Yang, a fourth-year doctoral student in the chemical and biomolecular engineering department, has played an active role in conducting the experiments surrounding the antibodies and refining the process of capturing them.
He said the researchers analyze antibodies by first flowing a “fermentation broth” through a membrane filter in order to capture the monoclonal antibody. From there, they use a secondary antibody that binds to the captured one and measures its fluorescence in the form of a light signal so they can determine its concentration.
“We want to make sure this batch of the monoclonal antibody has enough concentration that people are looking for so that they are safe,” Yang said.
Once they determine that the monoclonal antibody has the correct conditions, it is ready for patient use and can go out from the lab.
In the future, the research group aims to develop tests that can quickly test the fermentation broth for the right characteristics, such as the correct concentration and functional groups. By doing so, adjustments can be made to reach the right conditions in a matter of minutes rather than days.
The project has important ramifications for the manufacturing process of monoclonal antibodies. According to Bruening, instead of creating a new system for every new monoclonal antibody that a pharmaceutical company may develop, these filters may be applied to any process, making it far more efficient.
While this process has come a long way, Bruening clarified that it is constantly evolving. In fact, the research group hope to eventually make it publicly available. They have a National Science Foundation (NSF) grant, which opens the doors to the commercialization of the membranes. They are also currently working with a company to bring it to the market, because it is too difficult for people to make themselves.
In the meantime, improvements continue to be made, and the group plans to further refine and develop the process while remaining optimistic about the future.
“We need to improve it first,” Bruening said. “And then hopefully commercialize it.”