Rapid Characterization of Biosimilars

The development of biosimilars requires extensive physicochemical characterization of biosimilar candidate molecules, which should match the quality profile of the reference molecule (originator).

Here we use a novel method of thermal unfolding profiling to rapidly screen a variety of Fc-fusion protein biosimilar candidates. The best-in-class precision of the NanoTemper Technologies Prometheus nanoDSF instrument allowed for the ranking of biosimilar candidates according to the comparability of their unfolding profiles to the reference molecule. The results were in excellent agreement with conventional screening methods, while dramatically reducing sample consumption and measurement times. Thus, nanoDSF (miniaturized differential scanning fluorimetry) is a new and powerful tool for rapid screening approaches in biosimilar development. It enables narrowing down the number of promising candidates in hours instead of days or weeks.