Certolizumab Pegol Cimzia®
Certolizumab pegol is a PEGylated humanised Fab′ fragment directed against tumour necrosis factor alpha. Its Fc-free structure distinguishes it from full-length anti-TNF monoclonal antibodies and creates specific analytical questions for drug-concentration, anti-drug antibody and neutralising-antibody research. Three SHIKARI® assays address these complementary research domains.
Why Certolizumab is relevant to biological-drug monitoring research
Certolizumab has clinically important target biology, indication-specific dosing and measurable systemic exposure, making drug concentration and immunogenicity relevant research variables. Scientific source ↗ · EMA source ↗
Molecular Target & Structure
Certolizumab pegol is a PEGylated humanised Fab′ fragment directed against TNF-α. Unlike full IgG anti-TNF antibodies it lacks an Fc region. Source ↗
Approved Indications
EMA-authorised uses include rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis in defined adult patients. EMA source ↗
Loading-Phase Exposure
Where a general therapeutic trough range is not established, regulator pharmacokinetic data can provide regimen-specific exposure context:
Regulatory exposure values are regimen- and population-specific and are not therapeutic targets. Values vary with dose, timing, formulation and study population. This page is for RUO product information and does not provide clinical guidance.
Three complementary research assays
Enzyme immunoassay for the quantitative determination of certolizumab in human serum and plasma. Developed for concentration measurement across the Cmin–Cmax range in trough-level, pharmacokinetic and biosimilar research.
Enzyme immunoassay for the quantitative determination of antibodies to certolizumab in human serum and plasma, with confirmation. Designed for anti-drug antibody quantification and longitudinal immunogenicity research.
Qualitative enzyme immunoassay for detecting free neutralising antibodies to certolizumab in human serum and plasma. The kit includes positive, negative, cut-off and non-neutralising-antibody controls. No standard curve is shown because this is a qualitative assay.
Kit Specifications at a Glance
| Kit Name | Catalog Code | Type | Analyte | ELISA Format | Tests | Storage |
|---|---|---|---|---|---|---|
| SHIKARI® Q-CERT | CER-FD-CIM | Drug Levels | Certolizumab concentration | Quantitative enzyme immunoassay | 96 | 2–8°C |
| SHIKARI® S-ATCER | CER-QNS-CIM | Quantitative ADA | Anti-certolizumab ADA | Quantitative immunoassay with confirmation | 96 | 2–8°C |
| SHIKARI® T-CAP NAb Assay™ | CER-TCAP-NAb-CIM | T-CAP NAb™ | Free neutralising antibodies to certolizumab | Target Capture NAb Assay | 96 | 2–8°C |
* Store at +4°C and refer to the current protocol supplied with the kit. Shipping: room temperature.
Which kit fits your research question?
Choose the assay by analyte and measurement mode rather than treating drug, binding-antibody and neutralising-antibody results as equivalent.
Publications Using SHIKARI® Certolizumab Kits 1
All journal publications below are drawn from the Matrix Biotek Publications library and are shown newest first. Records are included when the publication database identifies the biological drug and SHIKARI® product use.
Ready to order, or need technical guidance?
Matrix Biotek can help identify the appropriate Certolizumab assay and prepare regional quotation and delivery information. SHIKARI® products are developed and manufactured in Ankara and supported through our European headquarters in Barcelona.