Analysis of polysorbate in GMP compliance


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

Surfactant characterization under GMP

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:

We also offer surfactant characterization services under R&D. Read more

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

Dr, Jörg Müller