Direct and Automated Surfactant Quantitation in Biologics Formulations
How to achieve fully automated, direct quantitation of nonionic surfactants in biologic drug formulations - without sample preparation or compound-specific standards.
Author(s)
Valentin Poirier
Key benefits and significance of the solution
This whitepaper presents a fully automated, benchtop NMR-based workflow for the direct quantitation of nonionic surfactants (NISs) such as polysorbates (PS80, PS20) and poloxamer 188 (P188) in biologic drug formulations. By integrating the Fourier 80 NMR spectrometer with the Advanced Chemical Profiling (ACP) software, this new methodology enables direct analysis of neat formulations - eliminating the need for sample preparation, complex chromatographic methods, or batch-specific surfactant standards. The entire process, from acquisition to reporting, is automated and requires no user input beyond sample loading. The approach is robust, precise, and scalable, supporting routine use in both CMC and QC environments, and can be extended to multi-attribute testing of other organic excipients.
Key points
- End-to-end automation: The workflow combines the Fourier 80 benchtop NMR, and the ACP software to deliver a true sample-to-report process, requiring no NMR expertise or manual intervention. Both data acquisition and quantitative analysis are carried out autonomously, with user involvement limited to submitting samples via the predefined method.
- High accuracy and precision: Across multiple surfactants and model formulations, the method achieved recoveries within 90–110% and relative standard deviations (RSDs) below 5%, well within the typical performances typically achieved with chromatography while significantly simplifying the analytical workflow.
- Robust and scalable platform: Results were shown to be reproducible across different instruments, sample series, and matrix compositions, demonstrating strong robustness to matrix variability, spectral interference, and system transfer.
Download the detailed whitepaper to learn how this automated NMR workflow can streamline surfactant in biologics, reduce time-to-result, and support platform procedures for routine QC and development.