Progress in analysis of host residual proteins in biological products
10.13200/j.cnki.cjb.004447
- VernacularTitle:生物制品宿主残余蛋白分析的研究进展
- Author:
FAN Peipei
- Publication Type:Journal Article
- Keywords:
Biological products;
Host residual proteins;
Electrophoresis;
Mass spectrometry
- From:
Chinese Journal of Biologicals
2025;38(03):373-378+383
- CountryChina
- Language:Chinese
-
Abstract:
Host cell proteins(HCPs) of biological products are endogenous host proteins expressed by host cells or produced when they die during the production of biological products. Incomplete elimination of HCPs is the main factor causing allergy or other adverse reactions. The analytical methods for HCPs mainly include SDS-PAGE, Western blot(WB), two-dimensional gel electrophoresis(2DE), ELISA, liquid chromatography, mass spectrometry and so on. Electrophoresis can provide qualitative and semi-quantitative determination for proteins, but the resolution and accuracy are low. ELISA has good reproducibility and high sensitivity, and is most widely used at present. Chromatography and mass spectrometry have high separation and resolution as well as accurate quantification, but high application cost. ELISA was used to determine HCPs in recombinant biological products in the general rules <3412>, <3413> and <3414> of Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition)and United States Pharmacopoeia(USP) <1132>. Analysis of HCPs components is helpful to improve the coverage of antiHCPs antibody and the sensitivity and specificity of detection methods. Traditional analytical methods can only qualitatively analyze HCPs, but cannot perform quantitative determination and characterization. Based on electrophoresis technology and mass spectrometry technology, combined with the development trend of HCPs component analysis at home and abroad, this paper summarizes the relevant HCPs analysis method to provide a reference for the verification of HCPs in the research and production process of biological products.
