Detection of Residual Host Cell Proteins in Biotherapeutic Drugs by Concatenated 2D LC-MS/MS.
| Autor: | Yang F; Protein Analytical Chemistry, Genentech, South San Francisco, CA, USA. yang.feng@gene.com., Li D; Protein Analytical Chemistry, Genentech, South San Francisco, CA, USA., Walker DE; Protein Analytical Chemistry, Genentech, South San Francisco, CA, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Methods in molecular biology (Clifton, N.J.) [Methods Mol Biol] 2022; Vol. 2313, pp. 269-279. |
| DOI: | 10.1007/978-1-0716-1450-1_16 |
| Abstrakt: | A sensitive and reliable two-dimensional LC-MS/MS method is described, which detects low level (≥10 ppm) host cell proteins (HCPs) in monoclonal antibody (mAb) drug products. This method applies a high pH-low pH two-dimensional reversed phase (RP) LC-MS/MS approach in conjunction with offline fraction concatenation, and uses a tandem column configuration for the second dimension RPLC. Direct database searching of MS/MS data through data-dependent acquisition (DDA) can be performed to identify the residual HCPs. The method impacts pharmaceutical company practices by using advanced LC-MS/MS technology to ensure product quality and patient safety. (© 2022. Springer Science+Business Media, LLC, part of Springer Nature.) |
| Databáze: | MEDLINE |
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