Direct and Automated Surfactant Quantitation in Biologics Formulations
Quantifying nonionic surfactants (NISs) like polysorbates and poloxamers in biologic formulations has long been a bottleneck. A fully automated workflow combining Bruker Fourier 80 benchtop NMR, Multisupp acquisition software package and Advanced Chemical Profiling (ACP) offers a compelling alternative that can address traditional challenges. This setup enables direct analysis of formulations without any sample preparation, surfactant-specific standards, extensive manual intervention, or in-depth expertise for result interpretation. This methodology was shown to deliver accurate, precise and reproducible results for the quantitation of the main NISs PS80, PS20, and P188. In addition, it proved robust against matrix variability and scalable for routine analysis, making streamlined NISs testing a practical reality.