This article examines the method for fully automated, direct quantification of nonionic surfactants in biologic drug formulations, utilizing no sample preparation or compound-specific standards.
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Benefits and significance of the solution
This article describes a completely automated, benchtop NMR-based approach for directly quantifying nonionic surfactants (NISs) such as polysorbates and poloxamer 188 in biologic drug formulations.
By combining the Fourier 80 NMR spectrometer with the Advanced Chemical Profiling (ACP) software, this novel technology enables the direct analysis of neat formulations, eliminating the need for sample preparation, complex chromatographic processes, or batch-specific surfactant standards.
The entire procedure, from acquisition to reporting, is automated and requires no user input other than sample loading. The method is reliable, precise, and scalable, making it suitable for frequent usage in both CMC and QC environments. It may also be used to test other organic excipients for several attributes.
Main highlights
End-to-end automation: The workflow combines the Fourier 80 benchtop NMR with the ACP software to create a true sample-to-report procedure that does not require any NMR experience or manual intervention. Both data collection and quantitative analysis are performed autonomously, with user interaction limited to submitting samples according to the stated procedure.
Excellent accuracy and precision: Across numerous surfactants and model formulations, the approach yielded recoveries of 90-110% and relative standard deviations of less than 5%, which are well within the average performance range for chromatography, while significantly simplifying the analysis workflow.
Robust and scalable platform: Results were consistent across multiple instruments, sample series, and matrix compositions, indicating high resilience to matrix variability, spectrum interference, and system transfer.
Download the complete article to see how this automated NMR workflow may streamline surfactants in biologics, shorten time-to-result, and support platform operations for routine quality control and development.
Download the full article here
Acknowledgments
This article was produced using materials originally written by Valentin Poirier.
About Bruker BioSpin Group
The Bruker BioSpin Group designs, manufactures, and distributes advanced scientific instruments based on magnetic resonance and preclinical imaging technologies. These include our industry-leading NMR and EPR spectrometers, as well as imaging systems utilizing MRI, PET, SPECT, CT, Optical and MPI modalities. The Group also offers integrated software solutions and automation tools to support digital transformation across research and quality control environments.
Bruker BioSpin’s customers in academic, government, industrial, and pharmaceutical sectors rely on these technologies to gain detailed insights into molecular structure, dynamics, and interactions. Our solutions play a key role in structural biology, drug discovery, disease research, metabolomics, and advanced materials analysis. Recent investments in lab automation, optical imaging, and contract research services further strengthen our ability to support evolving customer needs and enable scientific innovation.
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