Biologics, which are drugs made of biochemical compounds produced by living organisms, are becoming more common to treat a variety of conditions, including rheumatoid arthritis, chronic plaque psoriasis, and breast cancer. They’re usually proteins that are immensely easier to produce by plant or animal cells than synthesizing them from scratch in a complex chemical process. Yet, the same difference in manufacturing is a reason for the difficulty of maintaining quality control of such drugs: synthesizing allows for purity of production, but letting nature do it can lead to imperfect results.
Researchers at MIT have now developed a new approach for screening biologic proteins as soon as they’re produced, an approach that can also be applicable to testing the proteins just before an injection to more thoroughly guarantee safety. It relies on filters that can screen the proteins produced based on their size, an important physical quality that can point to protein molecules sticking to each other, a common problem during biologic protein production.
Their microfluidic device consists of an array of filters that let proteins of only a certain size through, resulting in an arrangement in which the proteins are positioned in a line based on size. Different size pores can be used within the filter system, allowing for the quality testing of proteins of widely different sizes.
The MIT team tested three commonly used biologics, including human growth hormone and interferon alpha-b, a promising cancer medication, and showed that the proteins that they purposely damaged were able to be filtered out by their device.
Study in Nature Nanotechnology: Nanofluidic device for continuous multiparameter quality assurance of biologics…
Via: MIT…
