In the pre-formulation study, we find the optimal formulation conditions for your biopharmaceuticals. The stability of a biopharmaceutical in solution is considered to be controlled by the pH and ionic strength of the solution, as well as the presence of sugars and surfactants. During the formulation process, these combinations are comprehensively explored to select the most stable conditions for storage.
U-Medico screens formulation conditions in a high-throughput and small-scale manner by combining physicochemical parameters such as colloidal stability, which is an indicator of the tendency of protein molecules to aggregate with each other, and protein structural stability, with efficient accelerated testing.
DynaPro (Wyatt Technology)
|Physicochemical parameters||Example: Colloidal stability (kDiff), Aggregation onset temperature (Tagg), Second virial coefficient (B22)|
|Analytical techniques||Example: pH, concentration, turbidity, solubility, size exclusion chromatography (SEC), viscosity, flow imaging analysis (FIA), SDS-PAGE, ion-exchange chromatography (IE), analytical ultracentrifugation (AUC), mass spectrometry (MS)|