Anti-Human IL-6R (Sarilumab) – Fc Muted™ HRP

Anti-Human IL-6R (Sarilumab) – Fc Muted™ HRP

Product No.: LT1707

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Product No.LT1707
Clone
Hu137
Target
IL-6
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
Interleukin-6, CDF; HGF; HSF; BSF2; BSF-2; IFNB2; IFN-beta-2
Isotype
Human IgG1κ
Applications
ELISA
,
FA
,
FC

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Antibody Details

Product Details

Reactive Species
Human
Host Species
Human
Expression Host
HEK-293 Cells
FC Effector Activity
Muted
Product Concentration
0.5 mg/ml
Formulation
This HRP-conjugated antibody is formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4, 1% BSA. (Warning: Use of sodium azide as a preservative will inhibit the enzyme activity of horseradish peroxidase)
Storage and Handling
This horseradish peroxidase conjugated monoclonal antibody is stable when stored at 2-8°C. Do not freeze.
Regulatory Status
Research Use Only (RUO). Non-Therapeutic.
Country of Origin
USA
Shipping
Next Day 2-8°C
Applications and Recommended Usage?
Quality Tested by Leinco
FC The suggested concentration for Alemtuzumab biosimilar antibody for staining cells in flow cytometry is ≤ 1.0 μg per 106 cells in a volume of 100 μl. Titration of the reagent is recommended for optimal performance for each application.
ELISA
Additional Applications Reported In Literature ?
FA
Additional Reported Applications For Relevant Conjugates ?
B
N
IHC (Paraffin)
IHC (Frozen)
WB
Each investigator should determine their own optimal working dilution for specific applications. See directions on lot specific datasheets, as information may periodically change.

Description

Description

Specificity
This non-therapeutic antibody uses the same variable region sequence as the therapeutic antibody Sarilumab. Sarilumab binds to the transmembrane and soluble forms of the IL-6 receptor. This product is for research use only.
Background
IL-6 and its signaling pathway play a part in immune response regulation, inflammation, and hematopoiesis.2 Sarilumab is a research-grade recombinant human monoclonal IL-6 receptor antagonist. It specifically binds to both the transmembrane and soluble forms of the IL-6 receptor, thus inhibiting IL-6–mediated cis and trans-signaling in a dose-dependent manner.1 Therapeutic Sarilumab, also known by the trade name Kevzara, is currently used to treat Rheumatoid Arthritis1, however, as of March 2020, The Feinstein Institute of Northwell Health publicized a study on "a human antibody that may prevent the activity" of IL-6 for the treatment of COVID-19.3 Anti-Human IL-6 (Sarilumab) utilizes the same variable regions from the therapeutic antibody Sarilumab making it ideal for research projects.
Antigen Distribution
IL-6R is ubiquitously expressed.
PubMed
NCBI Gene Bank ID
Research Area
Biosimilars
.
Cell Biology
.
Immunology
.
Innate Immunity
.
Neuroscience
.
Other Molecules

Leinco Antibody Advisor

Powered by AI: AI is experimental and still learning how to provide the best assistance. It may occasionally generate incorrect or incomplete responses. Please do not rely solely on its recommendations when making purchasing decisions or designing experiments.

Research-grade Sarilumab biosimilars are commonly used as calibration standards (analytical standards) or reference controls in PK bridging ELISA assays by preparing a dilution series with known concentrations to generate a standard curve for quantifying Sarilumab levels in serum samples.

In practice:

  • Calibration Standard Usage: Biosimilar Sarilumab is serially diluted (often in serum matrix) to create a range of concentrations that reflect expected sample values (e.g., 50–12800 ng/mL). These calibration standards are loaded onto ELISA plates alongside test samples. The concentration of Sarilumab in unknown samples is determined by interpolating their signal intensity against this standard curve.
  • Reference Controls: Biosimilars may also serve as reference controls, prepared at specific concentrations to monitor assay performance and accuracy. These controls—along with the calibrators—ensure that the ELISA can reliably detect and quantify Sarilumab across its intended range.

Key points for PK bridging ELISA with Sarilumab biosimilars:

  • A single analytical standard—usually the biosimilar—is preferred for both biosimilar and reference product quantification, minimizing variability and improving comparability between test and reference products.
  • Quality control samples, prepared from both biosimilar and reference Sarilumab, are quantified using the biosimilar standard curve to validate accuracy and precision across products.
  • Validation involves checking method performance (precision, accuracy) and ensuring equivalence of biosimilar and reference Sarilumab quantification, usually by statistical comparison of results against predefined acceptance criteria (e.g., bioanalytical equivalence intervals).
  • Standard curve preparation for PK bridging ELISA requires serial dilution of Sarilumab in human serum or buffer (as described in product literature), covering the relevant analytical range.

ELISA Procedure Summary (typical for Sarilumab):

  • Prepare reagents and standards (biosimilar Sarilumab, usually in neat human serum).
  • Dispense calibration standards, reference controls, and serum samples in designated wells.
  • Perform assay steps (adding capture and detection antibodies, wash steps, colorimetric detection).
  • Analyze results: Create the standard curve using known biosimilar concentrations, and interpolate unknowns against this curve.

This approach—using research-grade Sarilumab biosimilars for analytical standards and controls—assures robust, comparative, and regulatory-compliant measurement of drug concentrations in human serum samples in PK bridging ELISA studies.

Biopharma companies perform a comprehensive array of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to the originator (reference) biologic drug. These assays rigorously characterize both the molecular features and biological activity to ensure safety, efficacy, and regulatory compliance.

Typical analytical assays include:

  • Primary Structure Analysis: Confirms the amino acid sequence using techniques such as mass spectrometry and peptide mapping.
  • Higher-Order Structure Analysis: Evaluates protein folding with methods like circular dichroism (CD), nuclear magnetic resonance (NMR), and X-ray crystallography to verify secondary, tertiary, and quaternary structure.
  • Posttranslational Modification Characterization: Assesses glycosylation patterns, phosphorylation, and other chemical modifications that can influence function and immunogenicity.
  • Purity and Impurity Profiling: Uses methods such as high-performance liquid chromatography (HPLC), capillary electrophoresis, and SDS-PAGE to quantify protein purity, aggregates, fragments, and process-related impurities.
  • Biological and Functional Assays:
    • Potency Assays: Confirm that biological activity matches the reference (e.g., cell-based reporter assays).
    • Binding Studies: Measure the affinity and kinetics of interactions with target antigens or receptors (e.g., ELISA, surface plasmon resonance).
    • Enzyme Activity and Kinetics: Applicable to enzyme biologics.
  • Stability and Degradation Studies: Assess the stability profile under various storage and stress conditions to ensure consistency and robust shelf life.

The use of multiple, orthogonal assays—where different types of tests are used to confirm the same attribute—ensures robust and reliable evidence of similarity.

Leinco biosimilar reagents in analytical studies:

Leinco may refer to commercially available biosimilar reference standards or analytical controls, such as characterized monoclonal antibodies or proteins, that serve key roles in biosimilar analytical studies. Leinco biosimilars are used as high-quality reference materials to:

  • Benchmark analytical method performance: Serve as positive controls or comparators in binding, potency, and purity assays.
  • Establish assay sensitivity and specificity: Ensure the detection of meaningful similarities or differences in bioactivity or structure between the candidate biosimilar and authentic originator molecules.
  • Support validation of new analytical or functional assays: Confirm results are accurate and reproducible across platforms.

By providing characterized biosimilar-like molecules, Leinco biosimilars help ensure the quality, reliability, and regulatory acceptability of similarity assessments.

In summary: Analytical similarity assessment involves extensive physicochemical and functional testing—including structure, purity, modification profile, and potency—using cutting-edge, validated assays. Leinco biosimilars are often used as reference standards, assay controls, or comparators throughout this process to ensure robust, transparent, and reproducible similarity data.

References & Citations

1. Kevzara (sarilumab) injection [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals; Bridgewater, NJ: sanofi-aventis U.S.; May 2017.
2. Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int. 2014;2014:698313.
3. "Northwell Health Initiates Clinical Trials of 2 COVID-19 Drugs". 21 March 2020.
Indirect Elisa Protocol
FA
Flow Cytometry

Certificate of Analysis

Formats Available

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Disclaimer AlertProducts are for research use only. Not for use in diagnostic or therapeutic procedures.