Assessing Comparability of Higher-Order Structure of Biosimilars in Solution Using X-ray Scattering Methods
| Reference number | |
| Coordinator | Saromics Biostructures AB |
| Funding from Vinnova | SEK 424 512 |
| Project duration | November 2018 - January 2021 |
| Status | Completed |
| Venture | Research infrastructure - utilisation and collaboration |
| Call | Research infrastructure - utilisation and collaboration: Industrial pilot projects for neutron and photon experiments at large scale research infrastructures - 2018 |
| End-of-project report | 2018-04421_SARomicsBiostructures.pdf (pdf, 360 kB) |
Purpose and goal
The higher order structure (HOS) of biosimilars may affect their quality characteristics, including their safety, efficacy, and pharmacokinetic properties. For this reason, regulatory agencies require the assessment of the HOS of biosimilars as a step in their validation to ensure that new products adhere to patient safety principles. This project is focused on developing procedures and protocols for the characterization and comparison of antibodies and their biosimilars in solution using synchrotron small-angle X-ray scattering (SAXS).
Expected results and effects
The project gave us the opportunity to gain our own experience and evaluate the use of synchrotron-SAXS to compare antibodies and biosimilars. Collected data for the structure of the tested antibody and biosimilars could be analyzed and provided valuable insights into the system. A surprise in this context was that the scattering curves for the samples in the formulation solutions (the solutions used in injection in humans) show clear differences. This observation will be verified with new experiments and possibly published.
Planned approach and implementation
During the initial optimization process, several buffer solutions were tested using dynamic light scattering (DLS), the best solutions were selected for the following SAXS measurements. This work was carried out in close collaboration with Linköping University. Prof. Maria Sunnerhagen´s group has extensive experience in optimizing samples for SAXS experiments. For the SAXS data collection, we received help from Dr. D. Svergun´s group at the Synchrotron in Hamburg (DESY). In the future, the experience gained will be of the utmost importance in the execution of customer projects.