Abstract
The discovery and development of therapeutic proteins depend on reliable computational and biophysical characterization. Improvement of this process requires knowledge and understanding of protein structure and behaviour as a function of solution conditions. Here, we share a dataset on a diverse group of therapeutically relevant proteins, including their primary sequences, purity data, and an extensive computational and biophysical characterization as a function of solution pH and ionic strength. We find only weak correlations between many of
the determined biophysical parameters, indicating that these are not interchangeable. Further, we comment that a stability comparison of diverse therapeutic protein candidates should be based on biophysical characterization in multiple solvent conditions. Finally, we use the presented dataset to calculate several stability risk scores obtained with an increasing level of analytical effort and show how they correlate with storage stability data.
the determined biophysical parameters, indicating that these are not interchangeable. Further, we comment that a stability comparison of diverse therapeutic protein candidates should be based on biophysical characterization in multiple solvent conditions. Finally, we use the presented dataset to calculate several stability risk scores obtained with an increasing level of analytical effort and show how they correlate with storage stability data.
Original language | English |
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Pages (from-to) | 426-440 |
Number of pages | 15 |
Journal | Molecular Pharmaceutics |
Volume | 17 |
Issue number | 2 |
Early online date | 2 Dec 2019 |
DOIs | |
Publication status | Published - Feb 2020 |
Keywords
- developability assessment
- protein characterization
- protein formulation
- therapeutic proteins