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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...

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Detalles Bibliográficos
Autores principales: Kim, Minkyung, Ma, Youlong, Srinivasan, Charudharshini, O’Connor, Thomas, Telikepalli, Srivalli N., Ripple, Dean C., Lute, Scott, Bhirde, Ashwinkumar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2023
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