Assessing Comparability of Higher-Order Structure of Biosimilars in Solution Using X-ray Scattering Methods
|Coordinator||SARomics Biostructures AB|
|Funding from Vinnova||SEK 500 000|
|Project duration||November 2018 - November 2019|
|Venture||Research infrastructure - utilisation and collaboration|
|Call||Industriella pilotprojekt för neutron- och fotonexperiment vid storskalig forskningsinfrastruktur 2018|
Purpose and goal
In the development of new therapeutic antibody drugs and biosimilars it is essential to demonstrate stability and solubility of the drug candidates in solution. Using small- and wide angle X-ray scattering, this project will focus on the development of methods and protocols för assessing solution state and comparability of higher order structures (HOS) of biosimilars. These data are required by regulatory agencies for approval of biosimlars as therapeutic agents. SARomics Biostructures will collaborate with Linköping University and Pfizer in the development of these methods.
Expected results and effects
With the the inclusion of low- and wide angle X-ray scattering (SAXS and WAXS) in our services, we will be able to create a platform for quick and effective characterisation of biologics drugs. This is required for biosimilars approval by regulatory agencies like FDA. Taking into account the growing market for biosimilars, these services will open new business opportunities for SARomics Biostructures.
Planned approach and implementation
The three Work packages include: (1) Biophysical characterisation of samples (2) Initial SAXS measurements at Linköping University followed by measurements at the synchrotron Petra III at DESY, Hamburg, for obtaining high quality synchrotron data (3) Data processing and modelling in collaboration between Linköping University and SARomics Biostructures. P rotocols and methods developed during these experiments will be offered on the market by SARomics Biostructures as part of a services platform for characterisation of antibodies and biosimilars - and at new beamlines at MAX IV in Lund.