Dr. Yongchao Su Profile

Dr. Yongchao Su

at Merck Research Labs

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Proceedings Article | 6 March 2023 Presentation + Paper

Imaging protein aggregation in biopharmaceutical formulation with stimulated Raman scattering microscopy

Brian Wong, Xi Zhao, Yongchao Su, Dan Fu

Proceedings Volume 12368, 123680E (2023) https://doi.org/10.1117/12.2648675

KEYWORDS: Particles, Proteins, Image segmentation, Therapeutics, Raman spectroscopy, Raman scattering, Microscopy

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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.

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