REVIEW article
Front. Microbiol.
Sec. Microbiotechnology
Volume 16 - 2025 | doi: 10.3389/fmicb.2025.1658366
Residual Host Cell Proteins: Sources, Properties, Detection methods and Data acquisition modes
Provisionally accepted
- 1China State Institute of Pharmaceutical Industry Co Ltd, Shanghai, China
- 2School of Food and Biological Engineering, Jiangsu University, Zhenjiang, China
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Host cell proteins (HCPs) are process-related impurities derived from host organisms used for recombinant protein production in biopharmaceutical manufacturing. The generation of HCPs may lead to potential safety risks, such as immunogenicity, reduced drug efficacy and long-term side effects. Therefore, in the biopharmaceutical process, even trace amounts of HCPs need to be strictly regulated and controlled. The main bottlenecks associated with the detection of HCPs include a wide dynamic range of detection and instability of HCPs. Due to its high sensitivity and high resolution, mass spectrometry has attracted more and more attention in HCP detection, but it still cannot completely replace enzyme-linked immunosorbent assay (ELISA). The research in the future includes the development of more efficient sample pretreatment methods and data processing techniques to improve the sensitivity and accuracy of detection. At the same time, combined with risk assessment and process optimization, it is expected to further reduce the residual risk of HCP. This review discusses the sources, properties, pretreatment and detection of residual HCPs in therapeutic products, along with current regulatory considerations and future advancements.
Keywords: Host cell proteins, sources, characterization, pretreatment, detection
Received: 02 Jul 2025; Accepted: 29 Jul 2025.
Copyright: © 2025 Yao, Wen, Pan and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Hongjuan Pan, China State Institute of Pharmaceutical Industry Co Ltd, Shanghai, China
Ziwei Chen, School of Food and Biological Engineering, Jiangsu University, Zhenjiang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.