ReviewmAbs
Technical advancement and practical considerations of LC-MS/MS-based methods for host cell protein identification and quantitation to support process development.
Review in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 48 citations in OpenAlex.
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- The Production and Purification of Therapeutic Antibodies: A Comprehensive Analysis of Process- and Product-Related Contaminants.Biomolecules · 2026Review
- Article
- Application of a novel LC-MS-based proteomic workflow for host cell protein monitoring and risk control in biotherapeutics.Antibody therapeutics · 2026Article
- The Multi-Attribute Method (MAM), An Advanced LC-MS Approach for Protein A Resin Performance and Lifecycle Evaluation.Antibodies (Basel, Switzerland) · 2026Article
- LC-MS determination of Nicotiana benthamiana host plant proteins in the drug products of recombinant plant-produced pembrolizumab.Scientific reports · 2025Article
- Analytical Tools for HCP Detection, Identification, and Quantitation.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Characterization of host cell proteins in the downstream process of plant-Based biologics using LC-MS profiling.Biotechnology reports (Amsterdam, Netherlands) · 2024Article
- Carrier-Guided Proteome Analysis in a High Protein Background: An Improved Approach to Host Cell Protein Identification.Journal of proteome research · 2024Article
- 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
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 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
- Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics.The AAPS journal · 2023Review
- Nanobiosensors in neurodegenerative disease diagnosis: A promising pathway for early detection.Digital healthReview
- Use of LC-MS to characterize host cell protein removal during depth filtration.Biotechnology progressArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
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.