{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:43:29Z","timestamp":1787168609648,"version":"build-2736575974"},"reference-count":46,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T00:00:00Z","timestamp":1767744000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Drug Standards Improvement Project","award":["2025Y07"],"award-info":[{"award-number":["2025Y07"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/ph19010107","type":"journal-article","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T12:34:21Z","timestamp":1767789261000},"page":"107","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Machine Learning-Enabled Image Comparability Assessment for Flow Imaging Microscopy Across Platforms"],"prefix":"10.3390","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-6444-0183","authenticated-orcid":false,"given":"Zhenhao","family":"Zhou","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sha","family":"Guo","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youli","family":"Tian","sequence":"additional","affiliation":[{"name":"School of Automation and Intelligence Sensing, Shanghai Jiao Tong University, Shanghai 200240, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanhan","family":"Li","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2062-9994","authenticated-orcid":false,"given":"Zhiyun","family":"Qi","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"},{"name":"WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoying","family":"Chen","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"},{"name":"WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaxin","family":"Li","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongjiao","family":"Li","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Shenyang 110016, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pengfei","family":"He","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug 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