Application Notes

Use of self-interaction parameters derived from light scattering experiments for better developability assessment of biologic therapeutics

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©2021 NanoTemper Technologies, Inc. South San Francisco, CA, USA. All Rights Reserved. 8 APPLICATION NOTE To further validate the use of the scatting data from the EAP Panta, researchers examined if the ranking of candidates was consistent for a different Fc-fusion construct. Figure 6 shows that for all sample types and buffer formulations the trends were the same, enabling the EAP Panta to be used for candidate profiling for scalability 1 . Further refinement of the SLS optics and algorithm will enable true SLS measurements in future Panta devices. Together, these results demonstrate the importance of monitoring self-interaction of candidate protein molecules for better long-term success in the development of biologics 1 . Conclusions Protein-protein interactions are a crucial aspect for the ultimate success of a protein- based therapeutic. Accurate predictive models of high-concentration behavior of biologic therapeutics are needed to improve candidate outcomes and market success. Current 140.00 90.00 40.00 -10.00 -60.00 -110.00 Panta Plate reader Microcuvette Histidine 5.5 Histidine 5.5 + 8% Trehalose Histidine 7.0 + 8% Trehalose Histidine 7.0 Fc-fusion SLS deviation from linearity (%) Deviation from linearity (%) Figure 6: Systems that demonstrate a negative deviation from linearity via light scattering measurements are considered better candidates than those that exhibit positive deviation. The evaluated rankings of a bispecific Fc-fusion for each formulation are the same for all three instruments 1 .

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