ArticleJournal of industrial microbiology & biotechnology2019
Impact of mammalian cell culture conditions on monoclonal antibody charge heterogeneity: an accessory monitoring tool for process development.
Article in Journal of industrial microbiology & biotechnology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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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.
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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
18 citing papers in PubMed, 34 citations in OpenAlex.
- Review
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- Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants.Molecular pharmaceutics · 2024Article
- Effects of process intensification on homogeneity of an IgG1:κ monoclonal antibody during perfusion culture.Applied microbiology and biotechnology · 2024Article
- Two-Layer Inkjet-Printed Microwave Split-Ring Resonators for Detecting Analyte Binding to the Gold Surface.Sensors (Basel, Switzerland) · 2024Article
- Selectivity and Resolving Power of Hydrophobic Interaction Chromatography Targeting the Separation of Monoclonal Antibody Variants.Analytical chemistry · 2024Article
- Identification of sorbitol esterification of glutamic acid by LC-MS/MS in a monoclonal antibody stability assessment.PloS one · 2024Article
- Soft-sensor model development for CHO growth/production, intracellular metabolite, and glycan predictions.Frontiers in molecular biosciences · 2024Article
- Article
- Added Value of Internal Fragments for Top-Down Mass Spectrometry of Intact Monoclonal Antibodies and Antibody-Drug Conjugates.Analytical chemistry · 2023Article
- Pertuzumab Charge Variant Analysis and Complementarity-Determining Region Stability Assessment to Deamidation.Analytical chemistry · 2023Article
- Risk-Based Control Strategies of Recombinant Monoclonal Antibody Charge Variants.Antibodies (Basel, Switzerland) · 2022Review
- Site-Specific Glycan Microheterogeneity Evaluation of Aflibercept Fusion Protein by Glycopeptide-Based LC-MSMS Mapping.International journal of molecular sciences · 2022Article
- Structural and Functional Analysis of CEX Fractions Collected from a Novel AvastinPharmaceutics · 2022Article
- Efficacy of minute virus of mice (MVM) inactivation utilizing high temperature short time (HTST) pasteurization and suitability assessment of pasteurized, concentrated glucose feeds in Chinese hamster ovary (CHO) cell expression systems.Engineering in life sciences · 2021Article
- Quantification of glycated IgG in CHO supernatants: A practical approach.Biotechnology progress · 2021Article
- Model Transferability and Reduced Experimental Burden in Cell Culture Process Development Facilitated by Hybrid Modeling and Intensified Design of Experiments.Frontiers in bioengineering and biotechnology · 2021Article
- Animal-derived free hydrolysate in animal cell culture: Current research and application advances.Journal of tissue engineeringReview
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
Recombinant monoclonal antibodies are predominantly produced in mammalian cell culture bioprocesses. Post-translational modifications affect the micro-heterogeneity of the product and thereby influence important quality attributes, such as stability, solubility, pharmacodynamics and pharmacokinetics. The analysis of the surface charge distribution of monoclonal antibodies provides aggregated information about these modifications. In this work, we established a direct injection pH gradient cation exchange chromatography method, which determines charge heterogeneity from cell culture supernatant without any purification steps. This tool was further applied to monitor processes that were performed under certain process conditions. Concretely, we were able to provide insights into charge variant formation during a fed-batch process of a Chinese hamster ovary cell culture, in turn producing a monoclonal antibody under varying temperatures and glucose feed strategies. Glucose concentration impacted the total emergence of acidic variants, whereas the variation of basic species was mainly dependent on process temperature. The formation rates of acidic species were described with a second-order reaction, where a temperature increase favored the conversion. This platform method will aid as a sophisticated optimization tool for mammalian cell culture processes. It provides a quality fingerprint for the produced mAb, which can be tested, compared to the desired target and confirmed early in the process chain.
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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.