Anti-Human CTLA-4 (Ipilimumab) – HRP

Anti-Human CTLA-4 (Ipilimumab) – HRP

Product No.: LT1602

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Product No.LT1602
Clone
MDX-010
Target
CTLA-4
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
CD; GSE; GRD4; ALPS5; CD152; CTLA-4; IDDM12; CELIAC3
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
Active
Immunogen
Human CTLA-4
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 Ipilimumab 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
CyTOF®
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 Ipilimumab. Ipilimumab binds to Human CTLA-4. This product is for research use only.
Background
Cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) is a protein receptor that serves as an immune checkpoint and down-regulates the immune system. CTLA-4 is constitutively expressed in regulatory T cells but is only upregulated in conventional T cells following activation. Many cancers, including Melanoma, are associated with CTLA-4 upregulation because the body’s ability to recognize and destroy cancer cells is hampered by an inhibitory mechanism. Ipilimumab targets CTLA-4 and works by turning off this inhibitory mechanism and, thus, enhances the body’s own immune response against cancer cells.”2 Emerging research suggests that combined blockade of PD-1 and CTLA-4, with Nivolumab and Ipilimumab respectively, could produce greater antitumor activity than blockade of either pathway alone.1 This cost-effective, research-grade Anti-Human CTLA-4 (Ipilimumab) utilizes the same variable regions from the therapeutic antibody Ipilimumab making it ideal for research projects.
Antigen Distribution
CTLA4 is constitutively expressed in regulatory T cells.
PubMed
NCBI Gene Bank ID
Research Area
Biosimilars
.
Immunology

Leinco Antibody Advisor

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Research-grade Ipilimumab biosimilars are used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA assays to quantify Ipilimumab drug concentrations in serum samples by providing a known, validated comparator that allows for accurate quantitation of the antibody in patient samples.

In a typical PK bridging ELISA for Ipilimumab:

  • Calibration standards are prepared by diluting research-grade Ipilimumab (the biosimilar or reference standard) into drug-free human serum or buffer across a range of concentrations.
  • These standards are run in parallel with patient samples on ELISA plates coated with a specific capture reagent (commonly the target protein, CTLA-4, or an anti-Ipilimumab antibody).
  • After the binding and washing steps, a detection reagent (such as an HRP-conjugated anti-human IgG) is applied to quantify the amount of bound Ipilimumab.
  • The resulting optical density (OD) values for the standards are used to generate a standard curve. This curve establishes the relationship between the amount of Ipilimumab and the measured signal.
  • Serum samples from patients are then analyzed in parallel. Their OD values are interpolated against the standard curve to determine the unknown concentrations of Ipilimumab.

Reference controls (known concentrations of Ipilimumab) are also included in each run to confirm assay consistency and validity.

Essential details:

  • The use of a research-grade biosimilar ensures that the standard closely mimics the structure and immunological properties of the therapeutic antibody administered to patients.
  • Calibration standards must be prepared fresh or according to kit/assay protocol to minimize potential matrix effects and ensure accuracy.
  • Calibration ensures assay linearity, sensitivity, and specificity, supporting robust quantification of serum drug levels.

Summary table: Role of Ipilimumab biosimilars in ELISA PK quantitation

FunctionDescription
Calibration standardKnown concentrations used to construct a standard curve for quantitation
Reference controlQuality control sample to monitor assay reliability and performance
Basis for drug concentration readoutPatient sample ODs are interpolated on the standard curve generated from biosimilar
Ensures comparabilityClosely matches marketed drug for reliable PK assessments

References to ELISA protocols and standards:

  • The Abcam Ipilimumab ELISA Kit, for example, uses a standard curve generated from research-grade Ipilimumab, detecting serum concentrations in the range of 30–1000 ng/mL.
  • Assay Genie and other kit protocols specify similar use of calibration standards and controls for drug quantification in PK studies.

This methodology is essential for clinical pharmacokinetic monitoring, dose rationalization, and quality assurance in Ipilimumab therapy studies.

Biopharma companies use an extensive suite of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to the originator drug. These assays include methods for characterizing primary and higher-order structure, detecting posttranslational modifications, ensuring purity, and testing biological activity and potency.

Core analytical assays commonly performed:

  • Primary structure analysis: Mass spectrometry and peptide mapping are used to confirm the amino acid sequence and detect any structural differences.
  • Higher-order structure characterization: Techniques such as circular dichroism and nuclear magnetic resonance (NMR) spectroscopies are used to assess folding and conformation.
  • Posttranslational modification analysis: Methods such as glycan profiling, SDS-PAGE, and LC-MS/MS assess modifications like glycosylation that can affect function.
  • Purity and impurity profiling: High-performance liquid chromatography (HPLC), capillary electrophoresis, and size exclusion chromatography are used to quantify aggregates, variants, and contaminants.
  • Biological assays: Potency assays, binding assays (e.g., Fc receptor binding, cell surface ligand binding), and cell-based functional assays are used to confirm functional equivalence between the biosimilar and reference product.
  • Orthogonal methods and risk ranking: Manufacturers frequently apply complementary (“orthogonal”) techniques to provide robust evidence of similarity, focusing particularly on critical quality attributes most tied to safety and efficacy.

Functional Assays Focus:Functional assessments address whether any minor structural differences impact clinical efficacy or biological activity. For example, binding assays can demonstrate that a biosimilar antibody binds its target antigen and Fc receptors with the same affinity as the originator. Multiple, orthogonal assays are used to cover all relevant biological activities because "function follows form," and the ultimate goal is no clinically meaningful differences in action.

Role of Leinco Biosimilar Products:Leinco is a provider of biosimilar antibodies and proteins commonly used as reference standards or controls in these assays. Specifically:

  • Leinco biosimilars serve as standardized comparators in functional and structural assays to assess the analytical similarity of a developer’s candidate to both the originator and industry biosimilar standards.
  • They can be used in binding, potency, and cell-based bioassays, either as direct comparators or reference controls, to establish assay validity and confirm that the analytical methods are capable of distinguishing highly similar biological products.

In summary, biosimilar development relies on a comprehensive analytical and functional comparability package, where structural and biological similarity must be proven using highly sensitive, orthogonal assays, and reference biosimilars such as those from Leinco support this rigorous benchmarking process.

References & Citations

1. Wolchok, JD. et al. (2013) N Engl J Med 369(2):122-33.
2. Soo, RA. et al. (2017) Lancet Oncol. 18(12):e731-e741.
3. Lipson, EJ. and Drake, CG. (2011) Clin Cancer Res 17(22):6958-62.
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.