Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development

Host cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect product quality, stability, efficacy, or safety. Therefore, rem...

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Detalles Bibliográficos
Autores principales: Guo, Jia, Kufer, Regina, Li, Delia, Wohlrab, Stefanie, Greenwood-Goodwin, Midori, Yang, Feng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2023
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10208169/
https://www.ncbi.nlm.nih.gov/pubmed/37218066
http://dx.doi.org/10.1080/19420862.2023.2213365

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