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Analysis of residual CHO host cell protein in human erythropoietin products by UHPLC-MS*

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  • 1. Key Laboratory of the Ministry of health for Research on Quality and standardization of Biotech Products, National Institute of Food and Drug Control, Beijing 100050, China;
    2. Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201210, China

Received date: 2023-06-06

  Online published: 2024-06-24

Abstract

Objective: To analyze residual CHO host cell protein (HCP) in human erythropoietin (hEPO) products by UHPLC-MS. Methods: The hEPO bulks and internal protein standard were denatured, reduced, alkylated and digested; Accucore Vanquish C18 column connected with UHPLC and Q Exactive Plus Hybrid Quadrupole-Orbitrap Mass Spectrometer were employed to separate and detect the samples; qualitation and quantitation of HCP were performed using HCP workflow in BioPharma Finder 4.1 software. Results: Ten HCPs were detected in all 4 batches of hEPO bulks, and the HCP amounts varied between different samples, ranging from 25×10-6 to approximately 1 000×10-6; the CV% were below 10% for the HCPs above 50×10-6. Conclusions: The method of UHPLC-MS could be used for qualitative and quantitative analysis of HCP in hEPO products expressed in CHO system, and the HCP types and amounts in different samples varied considerably.

Cite this article

YU Lei, QIN Xi, ZHANG Xiao-xi, SHI Xin-chang, LI Xiang, ZHOU Yong . Analysis of residual CHO host cell protein in human erythropoietin products by UHPLC-MS*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(8) : 1402 -1407 . DOI: 10.16155/j.0254-1793.2023.08.16

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