Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development
Host cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect product quality, stability, efficacy, or safety. Therefore, rem...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2023.2213365 |
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| author | Jia Guo Regina Kufer Delia Li Stefanie Wohlrab Midori Greenwood-Goodwin Feng Yang |
| author_facet | Jia Guo Regina Kufer Delia Li Stefanie Wohlrab Midori Greenwood-Goodwin Feng Yang |
| author_sort | Jia Guo |
| collection | DOAJ |
| description | Host cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect product quality, stability, efficacy, or safety. Therefore, removal of HCPs to appropriate levels is critical for the bioprocess development of biotherapeutics. Liquid chromatography-mass spectrometry (LC-MS) analysis has become an important tool to identify, quantify, and monitor the clearance of individual HCPs. This review covers the technical advancement of sample preparation strategies, new LC-MS-based techniques, and data analysis approaches to robustly and sensitively measure HCPs while overcoming the high dynamic range analytical challenges. We also discuss our strategy for LC-MS-based HCP workflows to enable fast support of process development throughout the product life cycle, and provide insights into developing specific analytical strategies leveraging LC-MS tools to control HCPs in process and mitigate their potential risks to drug quality, stability, and patient safety. |
| format | Article |
| id | doaj-art-273decb2ae694d2098838e32ef9d9bf5 |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj-art-273decb2ae694d2098838e32ef9d9bf52025-08-20T03:25:59ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2213365Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process developmentJia Guo0Regina Kufer1Delia Li2Stefanie Wohlrab3Midori Greenwood-Goodwin4Feng Yang5Protein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USAPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyProtein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USAPharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, GermanyBiological Technologies, Genentech, A Member of the Roche Group, South San Francisco, CA, USAProtein Analytical Chemistry, Genentech, A Member of the Roche Group, South San Francisco, CA, USAHost cell proteins (HCPs) are process-related impurities derived from the manufacturing of recombinant biotherapeutics. Residual HCP in drug products, ranging from 1 to 100 ppm (ng HCP/mg product) or even below sub-ppm level, may affect product quality, stability, efficacy, or safety. Therefore, removal of HCPs to appropriate levels is critical for the bioprocess development of biotherapeutics. Liquid chromatography-mass spectrometry (LC-MS) analysis has become an important tool to identify, quantify, and monitor the clearance of individual HCPs. This review covers the technical advancement of sample preparation strategies, new LC-MS-based techniques, and data analysis approaches to robustly and sensitively measure HCPs while overcoming the high dynamic range analytical challenges. We also discuss our strategy for LC-MS-based HCP workflows to enable fast support of process development throughout the product life cycle, and provide insights into developing specific analytical strategies leveraging LC-MS tools to control HCPs in process and mitigate their potential risks to drug quality, stability, and patient safety.https://www.tandfonline.com/doi/10.1080/19420862.2023.2213365Host cell protein (HCP)identificationimpuritiesliquid chromatography tandem mass spectrometry (LC-MS/MS)process developmentquantitation |
| spellingShingle | Jia Guo Regina Kufer Delia Li Stefanie Wohlrab Midori Greenwood-Goodwin Feng Yang Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development mAbs Host cell protein (HCP) identification impurities liquid chromatography tandem mass spectrometry (LC-MS/MS) process development quantitation |
| title | Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development |
| title_full | Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development |
| title_fullStr | Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development |
| title_full_unstemmed | Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development |
| title_short | Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development |
| title_sort | technical advancement and practical considerations of lc ms ms based methods for host cell protein identification and quantitation to support process development |
| topic | Host cell protein (HCP) identification impurities liquid chromatography tandem mass spectrometry (LC-MS/MS) process development quantitation |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2023.2213365 |
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