ArticlemAbs
Host cell protein profiling of commercial therapeutic protein drugs as a benchmark for monoclonal antibody-based therapeutic protein development.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 53 citations in OpenAlex.
- Purification of Advanced Therapeutics by Flow-Through Pseudo-Affinity Chromatography: Bi-Specific mABs, Fc Fusion Proteins, and Adeno-Associated Viruses.Biotechnology and bioengineering · 2026Article
- From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars.Bioanalysis · 2026Article
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Quantitative Host Cell Protein Analysis of Antibody-Based Protein Therapeutics Using the Orbitrap Astral Mass Spectrometer.Journal of the American Society for Mass Spectrometry · 2026Article
- Article
- Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review.Biotechnology and bioengineering · 2025Review
- Analytical Tools for HCP Detection, Identification, and Quantitation.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Residual host cell proteins: sources, properties, detection methods and data acquisition modes.Frontiers in microbiology · 2025Review
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs.International journal of molecular sciences · 2024Article
- Identification and characterization of CHO host-cell proteins in monoclonal antibody bioprocessing.Biotechnology and bioengineering · 2024Article
- Effect of Host Cell Protein on Chinese Hamster Ovary Recombinant Protein Production and its Removal Strategies: A Mini Review.Current pharmaceutical biotechnology · 2024Review
- Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics.The AAPS journal · 2023Review
- Behavior of host-cell-protein-rich aggregates in antibody capture and polishing chromatography.Journal of chromatography. A · 2023Article
- Comparability strategy and demonstration for post-approval production cell line change of a bevacizumab biosimilar IBI305.Antibody therapeutics · 2023Article
- Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry.Journal of pharmaceutical analysis · 2023Article
- Analysis of Host Cell Proteins in Monoclonal Antibody Therapeutics Through Size Exclusion Chromatography.Pharmaceutical research · 2022Article
- Characterization of a SARS-CoV-2 spike protein reference material.Analytical and bioanalytical chemistry · 2022Article
- Article
- Review
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Therapeutic proteins including monoclonal antibodies (mAbs) are usually produced in engineered host cell lines that also produce thousands of endogenous proteins at varying levels. A critical aspect of the development of biotherapeutics manufacturing processes is the removal of these host cell proteins (HCP) to appropriate levels in order to minimize risk to patient safety and drug efficacy. During the development process and associated analytical characterization, mass spectrometry (MS) has become an increasingly popular tool for HCP analysis due to its ability to provide both relative abundance and identity of individual HCP and because the method does not rely on polyclonal antibodies, which are used in enzyme-linked immunosorbent assays. In this study, HCP from 29 commercially marketed mAb and mAb-based therapeutics were profiled using liquid chromatography (LC)-MS/MS with the identification and relative quantification of 79 individual HCP in total. Excluding an outlier drug, the relative levels of individual HCP determined in the approved therapeutics were generally low, with an average of 20 ppm (µmol HCP/mol drug) measured by LC-MS/MS, and only a few (<7 in average) HCP were identified in each drug analyzed. From this analysis, we also gained knowledge about which HCP are frequently identified in mAb-based products and their typical levels relative to the drugs for the identified individual HCP. In addition, we examined HCP composition from antibodies produced in house and found our current development process brings HCP to levels that are consistent with marketed drugs. Finally, we described a specific case to demonstrate how the HCP information from commercially marketed drugs could inform future HCP analyses.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.