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

Jia Guoa Protein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USACorrespondence[email protected]
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Regina Kuferb Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyView further author information

Delia Lia Protein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USAView further author information

Stefanie Wohlrabb Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyView further author information

Midori Greenwood-Goodwinc Biological Technologies, Genentech, A Member of the Roche Group, South San Francisco, CA, USAView further author information

Feng Yanga Protein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USACorrespondence[email protected]
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Regina Kufer, Vincent Larraillet, Sabrina Thalhauser, Tobias Graf, Manuel Endesfelder & Stefanie Wohlrab. (2024) Ubiquitin: Characterization of a Host Cell Protein Covalently Attached to a Monoclonal Antibody Product by LC-MS/MS. Journal of Pharmaceutical Sciences 113:6, pages 1470-1477.
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Patanachai K. Limpikirati, Sorrayut Mongkoltipparat, Thinnaphat Denchaipradit, Nathathai Siwasophonpong, Wudthipong Pornnopparat, Parawan Ramanandana, Phumrapee Pianpakt, Songsak Tongchusak, Maoxin Tim Tian & Trairak Pisitkun. (2023) Basic Regulatory Science Behind Drug Substance and Drug Product Specifications of Monoclonal Antibodies and Other Protein Therapeutics. Journal of Pharmaceutical Analysis.
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Kirk Haltaufderhyde, Brian J. Roberts, Sundos Khan, Frances Terry, Christine M. Boyle, Mitchell McAllister, William Martin, Amy Rosenberg & Anne S. De Groot. (2023) Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics. The AAPS Journal 25:5.
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Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development

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

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