ArticleBiotechnology progress
A novel approach to monitor clearance of host cell proteins associated with monoclonal antibodies.
Article in Biotechnology progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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Who cites it
32 citing papers in PubMed, 131 citations in OpenAlex.
- The Production and Purification of Therapeutic Antibodies: A Comprehensive Analysis of Process- and Product-Related Contaminants.Biomolecules · 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
- A two-column process for bispecific antibody purification based on MabSelect VL resin's strong byproduct removal capability.Journal of biological methods · 2025Article
- Comparative RNA-Seq of TenMarine drugs · 2024Article
- Effect of Host Cell Protein on Chinese Hamster Ovary Recombinant Protein Production and its Removal Strategies: A Mini Review.Current pharmaceutical biotechnology · 2024Review
- Polysorbates degrading enzymes in biotherapeutics - a current status and future perspectives.Frontiers in bioengineering and biotechnology · 2024Review
- Quantitation of Host Cell Proteins by Capillary LC/IMS/MS/MS in Combination with Rapid Digestion on Immobilized Trypsin Column Under Native Conditions.Mass spectrometry (Tokyo, Japan) · 2024Article
- Identification and characterization of CHO host-cell proteins in monoclonal antibody bioprocessing.Biotechnology and bioengineering · 2024Article
- Behavior of host-cell-protein-rich aggregates in antibody capture and polishing chromatography.Journal of chromatography. A · 2023Article
- Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry.Journal of pharmaceutical analysis · 2023Article
- Alternative Excipients for Protein Stabilization in Protein Therapeutics: Overcoming the Limitations of Polysorbates.Pharmaceutics · 2022Review
- Analysis of Host Cell Proteins in Monoclonal Antibody Therapeutics Through Size Exclusion Chromatography.Pharmaceutical research · 2022Article
- Process- and Product-Related Foulants in Virus Filtration.Bioengineering (Basel, Switzerland) · 2022Review
- Identification and classification of host cell proteins during biopharmaceutical process development.Biotechnology progress · 2022Article
- Detection and quantitation of host cell proteins in monoclonal antibody drug products using automated sample preparation and data-independent acquisition LC-MS/MS.Journal of pharmaceutical analysis · 2021Article
- Exploring sample preparation and data evaluation strategies for enhanced identification of host cell proteins in drug products of therapeutic antibodies and Fc-fusion proteins.Analytical and bioanalytical chemistry · 2020Article
- A novel approach to evaluate ELISA antibody coverage of host cell proteins-combining ELISA-based immunocapture and mass spectrometry.Biotechnology progress · 2020Article
- Targeted Capture of Chinese Hamster Ovary Host Cell Proteins: Peptide Ligand Discovery.International journal of molecular sciences · 2019Article
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Co-purification of a subset of host cell proteins (HCPs) with monoclonal antibodies (mAbs) during the capture of mAbs on Protein A affinity chromatography is primarily caused by interactions of HCPs with the mAbs. To date, there is limited information about the identity of those HCPs due to the difficulty in detecting low abundance HCPs in the presence of a large amount of the mAb. Here, an approach is presented that allows identification of HCPs that specifically associate with the mAb, while avoiding interference from the mAb itself. This approach involves immobilization of purified mAb onto chromatography resin via cross-linking, followed by incubation with HCPs obtained from supernatant of non-mAb producer cells that are representative of the expression systems used in mAb manufacturing. The HCPs that bind to the mAb are recovered and identified using mass spectrometry. This approach has not only allowed a comprehensive comparison of HCP subpopulations that associate with different mAbs, but also enabled monitoring of the effects of a variety of wash modifiers on the dissociation of individual HCP-mAb interactions. The dissociation of HCPs that associated with the mAb was monitored by enzyme-linked immunosorbent assay and mass spectrometry. This approach can be utilized as a screening tool to assist the development of effective and targeted wash steps in Protein A chromatography that ensures not only reduction of HCP levels copurified with the mAb but also removal of specific HCPs that may have a potential impact on mAb structural stability and patient safety.
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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.