ArticlemAbs
A modular and adaptive mass spectrometry-based platform for support of bioprocess development toward optimal host cell protein clearance.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed.
- Quantifying protein residues in APIs: Bradford assay mechanism and limitations, outperformed by HILIC-MS/MS.Journal of pharmaceutical analysis · 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
- Development of an Optimized LC-MS Workflow for Host Cell Protein Characterization to Support Upstream Process Development.Journal of proteome research · 2025Article
- A comparison of SWATH-MS methods for measurement of residual host cell proteins in adeno-associated virus preparations.Frontiers in bioengineering and biotechnology · 2025Article
- SWATH-MS insights on sodium butyrate effect on mAbs production and redox homeostasis in CHO cells.AMB Express · 2024Article
- Identification and characterization of CHO host-cell proteins in monoclonal antibody bioprocessing.Biotechnology and bioengineering · 2024Article
- Host cell protein quantification workflow using optimized standards combined with data-independent acquisition mass spectrometry.Journal of pharmaceutical analysis · 2023Article
- Risk control of host cell proteins in one therapeutic antibody produced by concentrated fed-batch (CFB) mode.Engineering in life sciences · 2023Article
- Changes in the Proteome Profile of People Achieving Remission of Type 2 Diabetes after Bariatric Surgery.Journal of clinical medicine · 2021Article
- A comprehensive CHO SWATH-MS spectral library for robust quantitative profiling of 10,000 proteins.Scientific data · 2020Article
- A novel approach to evaluate ELISA antibody coverage of host cell proteins-combining ELISA-based immunocapture and mass spectrometry.Biotechnology progress · 2020Article
- Host cell protein quantification of an optimized purification method by mass spectrometry.Journal of pharmaceutical and biomedical analysis · 2019Article
- Impact of a Heat Shock Protein Impurity on the Immunogenicity of Biotherapeutic Monoclonal Antibodies.Pharmaceutical research · 2019Article
- Data Independent Acquisition Mass Spectrometry Can Identify Circulating Proteins That Predict Future Weight Loss with a Diet and Exercise Programme.Journal of clinical medicine · 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
A modular and adaptive mass spectrometry (MS)-based platform was developed to provide fast, robust and sensitive host cell protein (HCP) analytics to support process development. This platform relies on one-dimensional ultra-high performance liquid chromatography (1D UHPLC) combined with several different MS data acquisition strategies to meet the needs of purification process development. The workflow was designed to allow HCP composition and quantitation for up to 20 samples per day, a throughput considered essential for real time bioprocess development support. With data-dependent acquisition (DDA), the 1D UHPLC-MS/MS method had excellent speed and demonstrated robustness in detecting unknown HCPs at ≥ 50 ng/mg (ppm) level. Combining 1D UHPLC with sequential window acquisition of all theoretical spectra (SWATH) MS enabled simultaneous detection and quantitation of all HCPs in single-digit ng/mg range within 1 hour, demonstrating for the first time the benefit of SWATH MS as a technique for HCP analysis. As another alternative, a targeted MS approach can be used to track the clearance of specific known HCP under various process conditions. This study highlights the importance of designing a robust LC-MS/MS workflow that not only allows HCP discovery, but also affords greatly improved process knowledge and capability in HCP removal. As an orthogonal and complementary detection approach to traditional HCP analysis by enzyme-linked immunosorbent assay, the reported LC-MS/MS workflow supports the development of bioprocesses with optimal HCP clearance and the production of safe and high quality therapeutic biopharmaceuticals.
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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.