Structure and thermal stability of therapeutic proteins in solid state formulations: Analysis of the SAXS/WAXS data
| Reference number | |
| Coordinator | MALMÖ UNIVERSITET - Department of Biomedical Science |
| Funding from Vinnova | SEK 287 881 |
| Project duration | February 2020 - October 2020 |
| Status | Completed |
| Venture | Research infrastructure - utilisation and collaboration |
| Call | Industrial pilot projects for the utilisation of neutron and photon based techniques at large-scale infrastructures - Autumn 2019 |
| End-of-project report | 2019-05280_SwedishOrphanBiovitrum.pdf (pdf, 454 kB) |
Important results from the project
In this project, synchrotron SAXS/WAXS was used to investigate the structure changes of proteins in the dry state and the effects of excipients on protein stability in these conditions. The structural analysis of proteins in solid states is novel and challenging since most of the available tools are only valid for dilute aqueous systems. Therefore, our goal is to develop new strategies in data analysis to be able to fully understand the structure of the proteins in solid state. A toolbox for processing of large data sets from large scale infrastructures has been developed succesfully.
Expected long term effects
We have successfully created a set of MatLab scripts to perform different steps in the data processing in order to identify quantitatively the changes of various structure origins of the protein during the dehydration and rehydration processes. This will provide a better understanding of the relation between material structure and stability, thus, contribute in the development of novel formulation platforms that improve convenience and therapeutic outcome for the patients. For the industry partner Sobi this is critical knowledge to to produce fully stable biological drugs.
Approach and implementation
The project results will be further developed together with other results collected in the collaborative project NextBioForm to provide guides for formulation of solid forms of proteins. Moreover, we also plan to incorporate the software in the data analysis pipeline of CoSAXS at Max IV to make it available for all users.