Imaging protein aggregation in biopharmaceutical formulation with stimulated Raman scattering microscopy

Brian Wong; Xi Zhao; Yongchao Su; Dan Fu

doi:10.1117/12.2648675

6 March 2023 Imaging protein aggregation in biopharmaceutical formulation with stimulated Raman scattering microscopy

Brian Wong, Xi Zhao, Yongchao Su, Dan Fu

Proceedings Volume 12368, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XXI; 123680E (2023) https://doi.org/10.1117/12.2648675
Event: SPIE BiOS, 2023, San Francisco, California, United States

Abstract

Particles in biopharmaceutical products present high risks due to their detrimental impacts on product quality and safety. Quantification and identification of particles in drug products are important to understand particle formation mechanisms, which could help control strategy development on particle formation during formulation development and manufacturing process. However, existing analytical techniques such as MFI and HIAC lack the sensitivity and resolution to detect particles with sizes smaller than 2 μm. More importantly, there is no chemical information available for determining particle content. In this work, we develop a Stimulated Raman Scattering (SRS) microscopy technique that overcomes these challenges by monitoring the C-H Raman stretching modes of the proteinaceous particles and a common contaminant (silicone oil). By comparing the relative signal intensity and spectral features of each component, most particles can be classified as protein, protein-silicone oil, or silicone oil. Our method has the capacity to quantify aggregation in protein therapeutics with chemical and spatial information in a label-free manner, potentially allowing high throughput screening or investigation of aggregation mechanisms.

Conference Presentation

Citation Download Citation

Brian Wong, Xi Zhao, Yongchao Su, and Dan Fu "Imaging protein aggregation in biopharmaceutical formulation with stimulated Raman scattering microscopy", Proc. SPIE 12368, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XXI, 123680E (6 March 2023); https://doi.org/10.1117/12.2648675

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