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Morphologically-Directed Raman Spectroscopy as an Analytical Method for Subvisible Particle Characterization in Therapeutic Protein Product Quality
Subvisible particles (SVPs) are a critical quality attribute of injectable therapeutic proteins (TPs) that needs to be controlled due to potential risks associated with drug product quality. The current compendial methods routinely used to analyze SVPs for lot release provide information on particle...
Autores principales: | Kim, Minkyung, Ma, Youlong, Srinivasan, Charudharshini, O’Connor, Thomas, Telikepalli, Srivalli N., Ripple, Dean C., Lute, Scott, Bhirde, Ashwinkumar |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10665318/ https://www.ncbi.nlm.nih.gov/pubmed/37993487 http://dx.doi.org/10.1038/s41598-023-45720-0 |
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