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Rapid Characterization of Biosimilars

Precise Biosimilar Candidate Profiling by nanoDSF

Dennis Breitsprecher, Florian Beck and Lukasz Kacprzyk

Biosimilar profiling using nanoDSF: Thermal unfolding of the originator and 17 biosimilar candidates

Comparison of triplicate thermal unfolding signals from the F350/F330 ratio and the single wavelength at 350 nm

Quantitative similarity profiling of nanoDSF data: Comparison of the unfolding signals and corresponding first derivative traces of the best match (sample #11) and the worst match (sample #01)

N-linked glycan analysis of the reference product and a candidate

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.

Facts, background information, dossiers
  • glycans
  • thermal unfolding profiling
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