Anti-Human VEGF (Bevacizumab) – Fc Muted™ HRP

Anti-Human VEGF (Bevacizumab) – Fc Muted™ HRP

Product No.: LT407

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Product No.LT407
Clone
A4.6.1
Target
VEGF
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
Vascular Endothelial Growth Factor; VEGF-A; VEGFA; Vascular Permeability Factor; VPF
Isotype
Human IgG1κ
Applications
ELISA
,
FC

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Antibody Details

Product Details

Reactive Species
Human
Host Species
Human
Expression Host
HEK-293 Cells
FC Effector Activity
Muted
Immunogen
Recombinant human VEGF.
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 Adalimumab 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 Reported Applications For Relevant Conjugates ?
B
N
IP
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 biosimilar antibody uses the same variable region sequence as the therapeutic antibody Bevacizumab. Bevacizumab recognizes both native and reduced human VEGF (isoform 165). This product is for research use only.
Background
Bevacizumab is a monoclonal antibody that specifically recognizes vascular endothelial growth factor (VEGF). VEGF is a growth factor that participates in angiogenesis, vasculogenesis, and endothelial cell growth. It facilitates endothelial cell proliferation, cell migration, and the permeabilization of blood vessels. In addition, VEGF inhibits apoptosis. Bevacizumab neutralizes the biological activity of VEGF by preventing the interaction of VEGF with its receptors on the surface of endothelial cells, resulting in the regression of tumor vascularization, normalization of remaining tumor vasculature, and inhibition of the formation of new tumor vasculature, thus inhibiting tumor growth.1 Anti-Human VEGF (Bevacizumab) utilizes the same variable regions from the therapeutic antibody Bevacizumab making it ideal for research projects.
Antigen Distribution
VEGF is widely expressed in the thyroid, prostate, and various other tissues.
PubMed
NCBI Gene Bank ID
Research Area
Biosimilars

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 Bevacizumab biosimilars are commonly used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA assays to ensure quantitative measurement accuracy and assay harmonization when determining Bevacizumab concentrations in serum samples.

  • In a PK bridging ELISA, the calibration standard (the material used to generate the standard curve) provides a quantitative reference for unknown samples. For biosimilar development, this standard can be either the reference product or the biosimilar candidate, provided their assay responses have been shown to be analytically equivalent under assay conditions.

  • Best practice dictates using a single PK assay and a single analytical standard (either the reference or the biosimilar) for quantifying both products in serum samples, after validating that the standard curves and analytical behavior of both are equivalent within the assay.

  • A typical protocol involves:

    • Preparing serial dilutions of the Bevacizumab biosimilar in sample dilution buffer to generate a calibration (standard) curve—e.g., 39.06 to 2500 ng/mL.
    • Spiking known concentrations of the biosimilar or reference material into serum to make quality control (QC) samples for assay validation and accuracy assessment.
    • Using the resultant standard curve to calculate concentrations of Bevacizumab (from either reference or biosimilar) in unknown serum samples.
  • Regulatory and scientific guidelines (including ICH and FDA) require that prior to selecting the biosimilar as a calibration standard, one must demonstrate and document that both the biosimilar and the reference product behave equivalently in the assay (i.e., comparable recovery, precision, and accuracy).

  • The WHO International Standard (IS) for Bevacizumab (e.g., NIBSC code 18/210) is available to serve as a global reference for calibrating secondary standards and harmonizing bioactivity and binding assays, reducing inter-laboratory variability. However, this IS is not intended for biosimilarity determination or direct clinical assay calibration, but rather for harmonizing bioactivity assessments across products.

In summary:

  • Research-grade biosimilar: Used as the ELISA calibration standard if validated for analytical equivalence against the reference.
  • Reference controls: Can include both the biosimilar and reference to act as comparators and QC samples during validation.
  • Purpose: Ensures accurate and harmonized quantification of Bevacizumab concentration in serum, supporting pharmacokinetic and comparability studies between biosimilars and reference products.

Biopharma companies use a comprehensive set of analytical assays to confirm that a proposed biosimilar matches the structural and functional attributes of the originator (reference) biologic. These assays are mandated as part of regulatory approval pathways, as structural and functional similarity is crucial for demonstrating that the biosimilar will be as safe and effective as the original drug.

Typical Analytical Assays for Biosimilar Characterization

  • Physicochemical Assays: Assess aspects like primary structure (amino acid sequence), secondary and tertiary structure, and higher-order structure using techniques such as mass spectrometry, peptide mapping, X-ray crystallography, and nuclear magnetic resonance (NMR). These confirm the molecule's identity and conformation.
  • Post-Translational Modifications: Analyze glycosylation patterns, charge variants, and oxidation or deamidation sites, as these can impact activity or immunogenicity. Methods include HPLC, capillary electrophoresis, and mass spectrometry.
  • Impurity Profiling: Evaluate product- and process-related impurities, such as aggregates and fragments, using chromatographic and electrophoretic methods. Impurity profiles act as fingerprints of the manufacturing process and must closely match the originator drug.
  • Potency Assays: Quantify the biological activity of the biosimilar using cell-based assays or mechanism-of-action-specific functional tests. These ensure that any structural similarity translates to expected biological activity.
  • Binding Assays: For antibody-based drugs, binding to the target antigen and to Fc receptors is tested to ensure functional equivalence. Fc receptor and antigen binding are typically measured by ELISA, surface plasmon resonance (SPR), or flow cytometry.
  • Orthogonal Methods: Multiple complementary techniques are often applied to probe the same attribute from different angles, increasing confidence in similarity claims.

Critical Quality Attributes (CQAs)
All these assays focus on critical quality attributes—molecular features shown to impact clinical performance, safety, or immunogenicity. Analytical risk assessments are used to identify and prioritize these attributes for deeper analysis.

How Biosimilars (like Leinco's) Are Used in These Studies
The text provided doesn’t specify any unique characteristics or uses of the Leinco biosimilar in these analytical comparability studies. In general practice:

  • Biosimilars, including those from Leinco, are subjected to the same comprehensive panel of structural and functional assays used for any biosimilar development program, as prescribed by regulations and outlined above.
  • The biosimilar is tested head-to-head with the originator/reference product across all these assays. Assay design must ensure sensitivity to potential differences that could affect safety or efficacy.

If "Leinco biosimilar" refers to Leinco Technologies' products, it should be noted that Leinco is a supplier of recombinant antibodies and reagents. Their biosimilar products are used by developers for assay validation, method development, and reference standard purposes, but the analytic comparability principles remain the same. No specific data from your search results indicate a unique use or regulatory approach for Leinco biosimilars distinct from any other biosimilar.

Summary Table: Key Analytical Assays for Biosimilar Comparability

Assay TypeWhat It MeasuresRelevance
Mass Spectrometry/Peptide MappingPrimary structure, modificationsMolecular identity
Circular Dichroism, NMR, FTIRHigher-order structureFolding and conformation
HPLC, Capillary ElectrophoresisPurity, impurities, aggregationBatch quality and consistency
ELISA, SPR, Flow CytometryAntigen/Fc receptor bindingPotency and functional similarity
Cell-based bioassaysBiological activity (mechanism-specific)Clinical efficacy prediction

In summary, biopharma companies apply a battery of sensitive, orthogonal analytical assays—including structural (physicochemical) and functional (potency, binding) tests—to comprehensively demonstrate biosimilarity, and biosimilars like those from Leinco are characterized by these same techniques in direct comparison with the originator.

References & Citations

1. Pazdur, R. et al. (2018) Clin Cancer Res. 24(18):4365-70.
Indirect Elisa Protocol
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.