| Autor: |
Delia Li, Feng Yang, Donald E. Walker |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Therapeutic Antibodies ISBN: 9781071614495 |
| Popis: |
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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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