Introduction
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 nanoDSF (miniaturized differential scanning fluorimetry), a novel method of thermal unfolding profiling, to rapidly screen a variety of Fc-fusion protein biosimilar candidates. This study shows that this technology has the potential to revolutionize similarity screening processes in biosimilar profiling. The best-in-class precision, reproducibility and data quality of the NanoTemper Technologies Prometheus nanoDSF instruments delivers high-quality thermal unfolding profiles which show even smallest differences between biosimilar variants. Thus, nanoDSF allows 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. Employing the Prometheus NT.48, up to 48 samples, each with a volume of just 10 μl and less than 1 μg of protein, can be measured in parallel. nanoDSF is therefore two orders of magnitude faster than the complimentary screening methods used here, which require ~ 1 week of lab work. Moreover, 150-times less protein is used for the analysis, rendering nanoDSF the perfect tool for large-scale screenings at early stages of biosimilar development.Optional automation allows for unattended analysis of hundreds of samples per day, resulting in previously unknown productivity. The flexibility, low consumable costs and maintenance-free operation of the system allows for its integration into virtually every step in the biosimilar development process. This enables scientists to perform quick and meaningful screenings with minimal time and material requirements to select candidates with similar structural properties based on their unfolding patterns.nanoDSF 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.
Abstract
The development of biosimilars requires extensive physicochemical characterization of biosimilar candidate molecules which should match the quality profile of the reference molecule (originator). This study shows that nanoDSF (miniaturized differential scanning fluorimetry), a novel method of thermal unfolding profiling, has the potential to revolutionize similarity screening processes. Download the full application note to learn more about nanoDSF in biosimilar development.
Contact Information:
Heide Marie Resch
Phone: +49 89 45 22 895 25
E-mail: [email protected]
Visit website
>> Download the full Application Note as PDF
Newsletters
Receive the latest analytical scientist news, personalities, education, and career development – weekly to your inbox.
