An assay to detect anti-tocilizumab antibodies in the presence of high levels of circulating target and drug is needed for immunogenicity assessment in comparative clinical studies. An assay was developed and validated using a combination of blocking agents and dilutions to overcome target interference challenges. No false-positive signal was detected in serum samples spiked with 350-500 ng/ml of IL-6 receptor. As low as 50 ng/ml of positive control antibodies could be detected in the presence of either 500 ng/ml of IL-6 or 250 μg/ml of the drug product. Assay also demonstrated high sensitivity, selectivity and precision. A robust, easy to perform immunogenicity assay was developed and validated for detecting anti-tocilizumab antibodies.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11352699 | PMC |
| http://dx.doi.org/10.1080/17576180.2024.2349417 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Mitigating target interference challenges in bridging immunogenicity assay to detect anti-tocilizumab antibodies.
Bioanalysis
August 2024
Clinical Bioanalytics, Biological Sciences, Biologics, Dr. Reddy's Laboratories Ltd., 8-2-337, Road No.3, Banjara Hills, Hyderabad 500034, Telangana, India.
An assay to detect anti-tocilizumab antibodies in the presence of high levels of circulating target and drug is needed for immunogenicity assessment in comparative clinical studies. An assay was developed and validated using a combination of blocking agents and dilutions to overcome target interference challenges. No false-positive signal was detected in serum samples spiked with 350-500 ng/ml of IL-6 receptor.
View Article and Find Full Text PDFMechanism-based approach using a biomarker response to evaluate tocilizumab subcutaneous injection in patients with rheumatoid arthritis with an inadequate response to synthetic DMARDs (MATSURI study).
J Clin Pharmacol
January 2014
Taga General Hospital, Ibaraki, Japan; Oasis Clinic, Ibaraki, Japan.
A multicenter, open-label, dose-escalation phase 1/2 study was undertaken to evaluate the optimal subcutaneous tocilizumab dose that would result in exposure comparable to the intravenous tocilizumab 8-mg/kg approved dose in patients with rheumatoid arthritis. A pharmacokinetic and biomarker approach was used to estimate the clinical optimal dose regimen of subcutaneous tocilizumab. Safety and efficacy of subcutaneous tocilizumab were assessed as secondary end points.
View Article and Find Full Text PDFEvaluation of a biosensor immunoassay for simultaneous characterization of isotype and binding region of human anti-tocilizumab antibodies with control by surrogate standards.
Anal Biochem
July 2009
Pharma Research Penzberg, Department of Bioanalytics, Roche Diagnostics, 82377 Penzberg, Germany.
This article describes the simultaneous Biacore analysis of human anti-human antibodies (HAHAs) with respect to the binding region and the isotype by a combination of 11 single measurements per sample. The multiplexing single assay setup made efficient use of the four parallel flow cells on one biosensor chip by immobilization of full-length antibody and its constant (Fc) and antigen binding (Fab) fragments for differential binding analysis of anti-drug antibodies (ADAs). Thereby, a complete time-specific immunogenicity profile (intensity, isotype, specificity, and kinetics) of a patient could be obtained by assessing the response patterns of serially collected samples analyzed in a single measurement run.
View Article and Find Full Text PDFTocilizumab, a humanized anti-interleukin-6 receptor antibody, ameliorates joint swelling in established monkey collagen-induced arthritis.
Biol Pharm Bull
June 2008
Product Research Department, Chugai Pharmaceutical Co., Ltd., Gotemba, Shizuoka, Japan.
We examined if tocilizumab, humanized anti-interleukin-6 receptor (IL-6R) antibody, can ameliorate joint swelling after the onset of arthritis in collagen-induced arthritis (CIA). CIA was induced by the immunization of bovine type II collagen in female cynomolgus monkeys. Tocilizumab (30 mg/kg) was administered weekly for 4 weeks after the onset of arthritis.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!