It is a regulatory requirement to provide data that confirms the identity and purity of your biopharmaceutical. Several of the techniques that BioPharmaSpec scientists utilizes in a characterization study yield orthogonal data that can be used for these purposes. Size-based gel electrophoresis is perhaps the most common methodology employed for the determination of identity and purity.
- Sodium Dodecyl Sulfate Poly-Acrylamide Gel Electrophoresis (SDS-PAGE)
- Capillary Electrophoresis – Sodium Dodecyl Sulfate Poly-Acrylamide (CE-SDS)
In many instances, CE- based separation techniques offer advantages over conventional electrophoretic separation methods, including high resolution, reproducibility and enhanced quantitation capabilities. Contact BioPharmaSpec to discuss the best technique for your biopharmaceutical product.