Detection of Residual Host Cell Proteins in Biotherapeutic Drugs by Concatenated 2D LC-MS/MS
Feng Yang1, Delia Li2, Donald E Walker2
1Protein Analytical Chemistry, Genentech, South San Francisco, CA, USA. yang.feng@gene.com.
Abstract:
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.
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