Physicochemical characterization of biological product is a critical step in the development and quality control. It involves a series of analytical techniques to assess the physical, chemical, and biological properties of the product, ensuring their safety, efficacy, and consistency. These characterizations are essential for regulatory approval and for understanding the molecule behaviour under different conditions, including formulation and storage.
Characterizing the inherent structural heterogeneity of a therapeutic monoclonal antibody is crucial for its development. Variations in molecular weight, charge heterogeneity, and post-translational modifications can impact in vivo stability, reduce biological activity, and potentially trigger undesirable immune responses.
| Description | Our Solutions |
|---|---|
| Glycan ProfilingLiquid Chromatography Techniques |
|
| Electrophoresis Techniques |
|
| DSF & SLS |
|
| Spectroscopy Techniques* |
|
| Absolute Molar Mass & Size (MALS)* |
|