Biosimilars are biologic products that are clinically similar to the government-approved reference product, or originator. They bring many benefits to patients including expanded treatment options and cost reduction.
One requirement of biosimilars is that they must have a molecular footprint that matches their originator. Any tiny difference in expression or purification methods can introduce structural alterations. Therefore, large-scale screenings are conducted early on during biosimilar development and include extensive physicochemical characterization of candidates against their reference molecule. These conventional analysis methods are laborious, low throughput, and can require large sample quantities.
In this application note, learn how scientists at UGA Biopharma used the Prometheus NT.48 system and nanoDSF technology to screen and rank their candidates during the early stages of biosimilar development. Since nanoDSF uses thermal unfolding to compare the structures of different molecules, the team was able to rank their biosimilar candidates according to the overall similarity to their reference molecule. They found that both the conventional approach and nanoDSF identified the same sample as the best match to the reference product. However, by using the Prometheus NT.48 system, they were able to use much less sample and rapidly analyze many more samples than the conventional method, making it perfect for large-scale screenings.