Analysis of polysorbate in GMP compliance
Coriolis Pharma offers its know-how in polysorbate quantification also as a GMP compliant service
Polysorbate is used as the most common surfactants in biopharmaceutical products in particular to protect proteins against interfacial stress. Coriolis has built up several years of experience in quantification of polysorbate content and profiling. With this know-how, we have also established this service under GMP. Following product-specific method optimization, our scientists validate methods for the specific purpose based on Liquid chromatography with charged aerosol detection (LC-CAD). This technique allows, in connection with an established LC-protocol, to resolve the main subclasses of polysorbate.
The tendency for degradation is an interrelated feature found in commercial polysorbates with a direct impact on the functional properties in biopharmaceutical products. LC-CAD is capable of following degradation kinetics in a straightforward way.
We have published several peer-reviewed journal articles about surfactant characterization:
- Kranz W. et al., Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation. J Pharm Sci. 2019 Jun
- Grabarek A. et al., What makes polysorbate functional? Impact of polysorbate 80 grade and quality on IgG stability during mechanical stress. J Pharm Sci. 2019 Oct
- Martos A. et al., Novel high-throughput assay for polysorbate quantification in biopharmaceutical products by using the fluorescent dye DiI. J Pharm Sci. 2019 Oct
- Martos a. et al., Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations. J Pharm Sci. 2017 Jul
We also offer surfactant characterization services under R&D. Read more