Analysis of polysorbate in GMP compliance

Coriolis Pharma offers its know-how in polysorbate quantification also as a GMP compliant service

Polysorbate (PS) 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 now also established this service under GMP. Following product-specific method optimization we can 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 PSs with a direct impact on the functional properties in biopharmaceutical products. LC-CAD is capable of following degradation kinetics in a straightforward way.

Relevant Coriolis publications:

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., Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations. J Pharm Sci. 2017 Jul

Further explore our analytical capabilities under GMP and get in contact with our experts today.

Contact us

For enquiries related to GMP analytics please contact Dr. Jörg Müller

Jörg Müller
HUND