Mass Spectrometry Method for the Detection of HCP Residues

Mass spectrometry is a highly sensitive qualitative and quantitative analysis method that has developed rapidly in recent years. Its application fields include biopharmaceuticals, environmental monitoring, food safety testing, and many other fields. In the field of biopharmaceuticals, it has a unique advantage in the analysis of proteins and peptide drugs. This article mainly discusses the application of mass spectrometry in the detection of host cell protein (HCP) residues.

 

Host cell protein (HCP) refers to proteins derived from the host cells of the expression system in the process of biopharmaceutical production. Since HCP can affect the safety, purity, and efficacy of drugs during biopharmaceutical production, strict control of HCP during drug production is necessary. The traditional HCP detection method is an enzyme-linked immunosorbent assay (ELISA), but the specificity and coverage of antibodies limit this method, which may lead to bias in the detection results.

 

Applications

Mass spectrometry is a method of qualitative and quantitative analysis of samples by ionizing sample molecules and measuring the mass and relative abundance of ions. In HCP residue detection, mass spectrometry can provide more comprehensive and accurate analysis results.

 

Analysis Workflow

1. Sample Preparation

Extract the biopharmaceutical sample to be detected, and perform protein extraction and concentration.

 

2. Protein Separation and Detection

Use liquid chromatography to separate the proteins in the sample, and then detect them with a mass spectrometer.

 

3. Data Analysis

Use mass spectrometry data processing software for protein qualitative and quantitative analysis.

 

The use of mass spectrometry in HCP residue detection is characterized by high sensitivity, high accuracy, and high throughput. It can achieve comprehensive detection of HCP, which is of great significance for improving the quality control level of biopharmaceuticals. However, there are still some problems in the practical application of mass spectrometry, such as complex sample processing and the need for high-level operation skills. In the future, it is necessary to improve and optimize the technology to make its application in the HCP residue detection of biopharmaceuticals more widespread.