Sha Guo

Dr. Sha Guo


Research Focus & Metrics

Academic Career Length

1Year (2026-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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7 January 2026 in Pharmaceuticals
Verified
Journal Article
Open access
PDF file
ZZZhenhao Zhou
Zhenhao Zhou
SGSha Guo
Sha Guo
YTYouli Tian
Youli Tian
HLHanhan Li
Hanhan Li
ZQZhiyun Qi
Zhiyun Qi
HWHao Wu
Hao Wu
Background/Objectives: The rapid development of biopharmaceuticals has heightened attention from both industry and regulatory agencies toward product quality, particularly regarding subvisible particles as a critical quality attribute. Existing pharmacopoeial methods, Light Obscuration (LO) and Microscopic Particle Count (MC), exhibit limitations in meeting increasingly refined analytical requirements. Flow Imaging Microscopy (FIM) technology shows promise as an alternative, yet its standardized methodologies are still under development. Methods: This study employed polystyrene microsphere standard beads and intravenous immunoglobulin to perform instrument standardization and consistency evaluations on FIM instruments sharing the same operating principles but from different manufacturers. The consistency and transferability of particle counting across platforms were assessed. Additionally, particle images obtained from parallel testing on two platforms were classified using confusion matrices based on convolutional neural networks and the Unified Manifold Approximation and Projection (UMAP) dimensionality reduction method. Results: This study investigated the consistency and developed a transfer strategy for particle counting results across different FIM platforms. Analysis of particle image classification confirmed the consistency of image-based categorization while also revealing the complexity associated with cross-platform image recognition. Conclusions: The findings provide valuable insights for the further standardization of Flow Imaging Microscopy, supporting its potential as a reliable analytical tool for subvisible particle analysis in biopharmaceutical quality control.

24 February 2026 in Journal of Pharmaceutical Sciences
Verified
Journal Article
Closed access
YCYunjiao Chi
Yunjiao Chi
XJXingchun Jiang
Xingchun Jiang
JLJun Li
Jun Li
YCYanli Cao
Yanli Cao
XQXiaoling Qi
Xiaoling Qi
HWHao Wu
Hao Wu