ArticleThe AAPS journal2017
Specific Immune Response to Phospholipase B-Like 2 Protein, a Host Cell Impurity in Lebrikizumab Clinical Material.
Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 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
34 citing papers in PubMed, 113 citations in OpenAlex.
- 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
- Elucidation of Proteoforms of Chinese Hamster Ovary (CHO) Phospholipase B-Like 2 (PLBL2) Captured From a Monoclonal Antibody.Biotechnology and bioengineering · 2026Article
- A quality evaluation strategy for residual host cell proteins based on orthogonal analysis.Frontiers in bioengineering and biotechnology · 2026Article
- The immunogenicity database collaborative: a standardized, publicly available database for clinical immunogenicity observations and insights.Frontiers in immunology · 2026Article
- Towards a cleaner CHO chassis: systematic knockout of host cell proteins for efficient biopharmaceutical manufacturing.Frontiers in bioengineering and biotechnology · 2026Article
- Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review.Biotechnology and bioengineering · 2025Review
- Studying host cell protein based on 2D nano-LC-MS/MS: comparison between the removal and the reservation of the main antibody components.Analytical and bioanalytical chemistry · 2025Article
- Analytical Tools for HCP Detection, Identification, and Quantitation.Methods in molecular biology (Clifton, N.J.) · 2025Article
- T cell assays for non-clinical immunogenicity risk assessment: best practices recommended by the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Optimising Monoclonal Antibody Drug Development for Inflammatory Bowel Disease.Clinical and experimental gastroenterology · 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
- Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 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
- Effect of Host Cell Protein on Chinese Hamster Ovary Recombinant Protein Production and its Removal Strategies: A Mini Review.Current pharmaceutical biotechnology · 2024Review
- 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
- Analysis of Host Cell Proteins in Monoclonal Antibody Therapeutics Through Size Exclusion Chromatography.Pharmaceutical research · 2022Article
- Review
- The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation.Antibody therapeutics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Host cell proteins are manufacturing process-related impurities that may co-purify with the product despite extensive efforts to optimize the purification process. The risks associated with these impurities can vary and may be patient and/or therapeutic dependent. Therefore, it is critical to monitor and control the levels of these impurities in products and their potential impact on safety and efficacy. Lebrikizumab is a humanized immunoglobulin G4 monoclonal antibody (mAb) that binds specifically to soluble interleukin 13. This mAb is currently in phase III clinical development for the treatment of asthma. Following initial phase III studies, the material used in lebrikizumab clinical trials was found to have a process-related impurity identified as Chinese hamster ovary phospholipase B-like 2 (PLBL2) which co-purified with lebrikizumab. The immunogenic potential of PLBL2 and its potential impact on the immunogenicity of lebrikizumab in clinical studies were therefore evaluated. Data from the clinical studies demonstrated that ∼90% of subjects developed a specific and measurable immune response to PLBL2. Given the high incidence of antibodies to PLBL2 as well as the comparable safety profile observed between placebo- and drug-treated subjects, no correlation between safety events and anti-PLBL2 antibodies could be made. Additionally, no impact on the incidence of anti-lebrikizumab antibodies was observed, suggesting the lack of an adjuvant effect from PLBL2. Interim analysis from ongoing phase III studies using material with substantially reduced levels of PLBL2 with patients having had longer exposure shows significantly less and dose-dependent frequency of immune responses to PLBL2.
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.