Anti-Human IL-6R (Sarilumab) – HRP

Anti-Human IL-6R (Sarilumab) – HRP

Product No.: LT1702

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Product No.LT1702
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
Active
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 used as calibration standards (analytical standards) or reference controls in pharmacokinetic (PK) bridging ELISA assays to enable accurate and reproducible measurement of Sarilumab concentrations in serum samples.

Essential context and supporting details:

  • Calibration Standards:
    In a PK bridging ELISA, the assay requires a standard curve constructed from known concentrations of Sarilumab biosimilar prepared in a relevant matrix, typically human serum. These standards allow for quantification of Sarilumab drug concentrations by interpolating the absorbance values of unknown serum samples against the standard curve.

  • Reference Controls:
    Biosimilar Sarilumab is also used as positive controls and quality control (QC) samples to ensure the assay's accuracy, precision, and reproducibility across runs. These controls are tested alongside unknown samples to verify the assay’s performance parameters.

  • Assay Process Overview:
    The ELISA involves adding both standards (biosimilar Sarilumab at defined concentrations) and unknown serum samples to a microplate where they are captured by immobilized target (e.g., IL-6Rα for Sarilumab) and detected by labeled secondary antibodies specific to Sarilumab or its light chain. The completed sandwich generates a signal (colorimetric) proportional to the amount of Sarilumab present.

  • Single Analytical Standard for Bridging PK:
    Regulatory and industry best practice for biosimilar development is to use a single PK assay with one analytical standard (typically the biosimilar itself), to quantify both the biosimilar and reference (originator) product concentrations in serum samples. This approach minimizes assay variability, simplifies method validation, and ensures direct comparability of results.

  • Method Validation:
    Prior to use in clinical sample testing, the PK ELISA method is validated using Sarilumab biosimilar standards and QC samples prepared at multiple concentrations (e.g., 50–12,800 ng/mL) to demonstrate precision, accuracy, linearity, and specificity. Statistical analysis is applied to confirm the equivalence of biosimilar and reference product detection within the assay.

  • Summary Table: Roles in PK Bridging ELISA

ApplicationBiosimilar Sarilumab providesExample Usage
Calibration StandardKnown concentration for standard curveQuantification of samples
Reference/ControlAssay validation, performance checksQC samples, routine controls
Method ComparabilityEnsures both biosimilar & originator are measurable in same assayPK bridging studies
  • Why Biosimilars?
    Biosimilar versions are highly similar to the originator in sequence, structure, and functional activity, making them suitable as analytical comparators and standards in research and preclinical development.

In summary, research-grade Sarilumab biosimilars are central to PK bridging ELISAs as both calibration standards and reference controls, enabling sensitive, accurate, and validated quantification of Sarilumab concentration in serum samples for pharmacokinetic studies of biosimilars versus reference biologics.

Biopharma companies typically perform a comprehensive array of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to its originator drug, focusing on critical quality attributes (CQAs) such as physiochemical properties, structural features, biological potency, and impurity profiles.

Essential context and supporting details:

  • Structural Similarity Assays:

    • Primary structure: Amino acid sequencing and peptide mapping via mass spectrometry.
    • Secondary and higher order structure: Circular dichroism, differential scanning calorimetry, NMR, and X-ray crystallography.
    • Post-translational modifications: Glycosylation analysis, disulfide bond mapping.
    • Physicochemical properties: Chromatography (HPLC, SEC), electrophoresis (SDS-PAGE, CE).
    • Aggregate analysis: SEC, analytical ultracentrifugation.
    • Impurity profiling: Mass spectrometry, HPLC, and characterization of product- and process-related impurities.
  • Functional Similarity Assays:

    • Biological potency: Cell-based assays measuring drug activity.
    • Binding assays: ELISA, surface plasmon resonance, Fc receptor or target-binding affinity.
    • Enzyme kinetics tests: To confirm equivalent enzymatic activity.
    • Mechanism-specific assays: Depending on the biotherapeutic, e.g., ADCC, CDC, Fc-mediated effector functions.
  • Assessment approach:

    • Biosimilar developers employ head-to-head comparison studies using orthogonal methods—multiple complementary analytical techniques—to identify and evaluate any differences between the biosimilar and the reference product.
    • These assays must demonstrate that observed differences do not impact clinical performance, safety, or efficacy.

Leinco biosimilars:
While the specific use of Leinco biosimilars in biosimilarity studies is not detailed in the retrieved sources, Leinco is known in industry as a supplier of high-quality biosimilar reference standards and antibodies. Such reagents are typically used by biopharma companies for:

  • Establishing reference standards for comparative analytical testing.
  • Serving as controls in binding and cell-based bioassays.
  • Supporting the qualification and calibration of analytical platforms used in biosimilarity assessment.

Thus, Leinco biosimilars are commonly employed as trusted comparators or assay reagents in the analytical packages designed to demonstrate biosimilarity. These reagents help ensure the validity and reliability of the comparative analytical results essential for regulatory approval. However, specific details about the role of Leinco biosimilars in published biosimilarity studies were not provided in the search results, and this explanation is based on industry practice.

Key additional information:

  • The primary regulatory standard guiding analytical similarity, ICH Q6B, emphasizes the requirement for detailed and validated comparative studies, with an evolving landscape of advanced analytical tools.
  • The published literature catalogues biosimilarity assessment studies and analytical platforms used for various recombinant biotherapeutics, supporting best practices in the field.

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.