Test Introduction

The production of biomedicine uses the same subculture, but contamination occurs as the protein inside the host cell is refined simultaneously with the medicine during the production process. Because the residual host cell protein (HCP) negatively affects the drug stability, it is essential to detect and the 동정 HCP contamination during the biopharmaceutical development process. In order to supplement the ELISA-based HCP analysis, the orthogonal detection and monitoring technologies including LC-MS/MS and CESI-MS/MS are used. For instance, LC-MS/MS not only detects and performs the characteristic analysis of the HCP inside the substance used for biopharmaceutical production, but also provides the direct import of the individual protein equivalency information from the entire data instead of the total HCA, which is the limitation of the current ELISA-based analysis method.

Sample

• Antibody
• Antibody-drug conjugates
• Recombinant protein
• Toxine
• Vaccine

Analysis Process

Analysis Result