Innovative approach to support therapeutic proteins' similarity in hydrodynamic size using high-throughput dynamic light scattering and forced degradation.
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| Title: | Innovative approach to support therapeutic proteins' similarity in hydrodynamic size using high-throughput dynamic light scattering and forced degradation. |
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| Authors: | Bhirde A; Division of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. ashwinkumar.bhirde@fda.hhs.gov., Harish S; Division of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Trunfio N; Division of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., de Luna IF; Division of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Smith W; Division of Product Quality Research V, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Fu Q; Division of Product Quality Assessment XIV, Office of Pharmaceutical Quality Assessment III, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. |
| Source: | Scientific reports [Sci Rep] 2025 Nov 22; Vol. 15 (1), pp. 41481. Date of Electronic Publication: 2025 Nov 22. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 2045-2322 |
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| DOI: | 10.1038/s41598-025-97377-6 |
