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.

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