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

• Main Authors: Jia Guo (Author), Regina Kufer (Author), Delia Li (Author), Stefanie Wohlrab (Author), Midori Greenwood-Goodwin (Author), Feng Yang (Author)
• Formato: Livro
• Publicado em: Taylor & Francis Group, 2023-12-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: Connect to this object online.

ABSTRACTHost 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. Theref...