ArticleThe AAPS journal2016
Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics.
Article in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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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
42 citing papers in PubMed, 95 citations in OpenAlex.
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- From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development.Bioanalysis · 2026Review
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products.The AAPS journal · 2026Article
- Current regulatory requirements for assessment of immunogenicity for gene therapy medicinal products.Cell reports. Medicine · 2025Review
- Hydrogels in the Immune Context: In Vivo Applications for Modulating Immune Responses in Cancer Therapy.Gels (Basel, Switzerland) · 2025Review
- Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review.Biotechnology and bioengineering · 2025Review
- Computational Immunogenetic Analysis of Botulinum Toxin A Immunogenicity and HLA Gene Haplotypes: New Insights.Toxins · 2025Article
- T cell assays for non-clinical immunogenicity risk assessment: best practices recommended by the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Residual host cell proteins: sources, properties, detection methods and data acquisition modes.Frontiers in microbiology · 2025Review
- Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Recombinant Adeno-Associated Virus Vectors for Gene Therapy of the Central Nervous System: Delivery Routes and Clinical Aspects.Biomedicines · 2024Review
- Tenecteplase: biochemical and clot lysis activity comparisons.Frontiers in pharmacology · 2024Article
- Assessing MAPPs assay as a tool to predict the immunogenicity potential of protein therapeutics.Life science alliance · 2024Article
- Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics.The AAPS journal · 2023Review
- Risk control of host cell proteins in one therapeutic antibody produced by concentrated fed-batch (CFB) mode.Engineering in life sciences · 2023Article
- Thermostable chaperone-based polypeptide biosynthesis: Enfuvirtide model product quality and protocol-related impurities.PloS one · 2023Article
- Analysis of Host Cell Proteins in Monoclonal Antibody Therapeutics Through Size Exclusion Chromatography.Pharmaceutical research · 2022Article
- Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology.Journal for immunotherapy of cancer · 2022Review
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A potential risk factor for immunogenicity of a biotherapeutic is the low levels of host cell protein (HCP) impurities that remain in the product following the purification process. During process development, significant attention has been devoted to removing HCPs due to their potential safety risk. Samples from different purification steps of several monoclonal antibodies (mAbs) purified by one type of platform were evaluated for their residual Chinese Hamster Ovary (CHO) cell-derived HCP content. HCPs in both in-process (high levels of HCP) and highly purified (low levels of HCP) samples were identified and quantitated by proteomic analysis via mass spectrometry. The responses to HCPs were evaluated in an in vitro assay using PBMC from a population of healthy and disease state individuals. Results indicated that samples with up to 4000 ppm HCP content (levels 200 times greater than the drug substance) did not pose a higher immunogenicity risk than highly purified mAb samples. As an orthogonal method to predict immunogenicity risk, in silico algorithms that probe amino acid sequence for foreign epitope content were used to evaluate over 20 common HCPs (identified in the different mAb samples). Only a few HCPs were identified as high risk by the algorithms; however, the in vitro assay results indicated that the concentration of these HCPs from in-process biotherapeutic mAb samples was not sufficient to stimulate an immune response. This suggests that high levels of HCP in mAb biotherapeutics purified by this type of platform do not increase the potential risk of immunogenicity of these molecules. Insights from these studies can be applied to HCP control and risk assessment strategies.
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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.