Anti-Human CD52 (Alemtuzumab) – HRP

Anti-Human CD52 (Alemtuzumab) – HRP

Product No.: LT202

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Product No.LT202
Clone
Campath-1H
Target
CD52
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
HE5; CDW52; EDDM5 CDW52; Cambridge pathology 1 antigen
Isotype
Human IgG1κ
Applications
ELISA
,
FA
,
FC

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Antibody Details

Product Details

Reactive Species
Cynomolgus Monkey
Rhesus Monkey
Human
Host Species
Human
Expression Host
HEK-293 Cells
FC Effector Activity
Active
Immunogen
Human lymphocytes.
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.
Additional Applications Reported In Literature ?
FA
ELISA
Additional Reported Applications For Relevant Conjugates ?
CyTOF®
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 Alemtuzumab. Clone Campath-1H recognizes human CD52. This product is for research use only.
Background
Clone Campath-1H is a monoclonal antibody that specifically binds to CD52, a protein present on the surface of mature lymphocytes. However, this protein is not present on the stem cells that generated these lymphocytes. Alemtuzumab is targets and destroys mature lymphocytes containing CD-52, and is used to treat chronic lymphocytic leukemia (CLL) and multiple sclerosis. Anti-Human CD52 (Alemtuzumab) utilizes the same variable regions from the therapeutic antibody Alemtuzumab making it ideal for research projects.
Antigen Distribution
CD52 is primarily expressed on the surface of mature lymphocytes. Additionally, CD52 is present on most lymphoid derived malignancies. However, variable expression on Myeloma cells should be noted.
PubMed
NCBI Gene Bank ID
Research Area
Biosimilars

Leinco Antibody Advisor

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The use of research-grade Alemtuzumab biosimilars as calibration standards or reference controls in a pharmacokinetic (PK) bridging ELISA involves several key steps and considerations:

Calibration Standards Preparation

  1. Preparation of Calibration Standards: Research-grade Alemtuzumab biosimilars are prepared in human serum to reflect the biological matrix in which the drug will be measured. This helps to ensure that the assay accurately reflects the drug's concentration in the serum samples of patients.

  2. Standardization: Calibration standards are typically prepared across a range of concentrations, including the expected therapeutic range of Alemtuzumab. These standards are often compared against each other to ensure consistency between different batches of the drug.

  3. Validation: The calibration standards are validated to ensure precision and accuracy according to international guidelines such as those from the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). This validation includes assessing the linearity of the assay, its sensitivity, and its ability to detect the drug at low concentrations.

Assay Design and Execution

  1. ELISA Assay Format: The ELISA for Alemtuzumab typically uses a sandwich format, where capture antibodies are bound to a plate, and detection antibodies are used to quantify the drug concentration. This format ensures specificity and sensitivity.

  2. Quality Controls: In addition to calibration standards, quality control samples are prepared and analyzed to monitor assay performance and ensure that the results are reliable and consistent.

  3. Sample Dilution: Since Alemtuzumab concentrations can vary significantly, serum samples are often diluted before analysis to ensure they fall within the assay's dynamic range. The dilution factor is taken into account when calculating the final concentration.

Use in Pharmacokinetic Studies

  1. Pharmacokinetic Analysis: The primary goal of using Alemtuzumab biosimilars as calibration standards in PK ELISA is to accurately measure drug concentrations in serum samples over time. This allows for the calculation of pharmacokinetic parameters such as peak concentration (Cmax) and area under the concentration-time curve (AUC).

  2. Bridging Studies: PK bridging studies are conducted to compare the pharmacokinetic profiles of a biosimilar and its reference drug. By using standardized calibration standards, these studies can ensure that any differences in pharmacokinetics between the biosimilar and the originator drug are accurately detected.

By employing these methods, researchers can confidently use Alemtuzumab biosimilars as calibration standards to support PK studies and ensure the equivalent efficacy and safety of biosimilar drugs compared to their reference counterparts.

Biopharma companies typically perform a wide range of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to the originator drug. These analytical assays are crucial for establishing the comparability of the biosimilar, which is essential for regulatory approval. Here's a breakdown of the typical analytical assays used:

Structural Analytical Assays

  • Physicochemical Assays: These include primary, secondary, and higher-order structure analysis, as well as assessments of post-translational modifications such as glycosylation patterns. Techniques like mass spectrometry and chromatography are used to evaluate product-related impurities and process impurities.
  • Characterization of Aggregates and Variants: This involves identifying and quantifying product-related variants, such as aggregates, precursors, fragments, or other modified forms.

Functional Analytical Assays

  • Binding Assays: These assess how well the biosimilar binds to its target, which is crucial for its biological function. For example, Fc receptor binding assays can evaluate the interaction with immune receptors.
  • Biological Potency Assays: These determine the biological activity of the biosimilar, often using cell-based assays to mimic the biological environment.
  • Enzyme Kinetics and Other Functional Studies: These might include enzyme activity assays or other methods to assess the biosimilar's functional capabilities compared to the originator.

Leinco Biosimilar Role

The query does not provide specific information about how Leinco biosimilars are used in these studies. However, in general, biosimilars like those from Leinco would undergo the same rigorous testing as any other biosimilar, focusing on demonstrating structural and functional similarity to their respective originator drugs.

Regulatory and Quality Control Considerations

The choice of assays is guided by regulatory considerations, such as those outlined in ICH Q6B. It is essential to use orthogonal methods—multiple complementary techniques—to ensure comprehensive characterization and to mitigate any uncertainties arising from minor differences in structure or function. The analytical similarity assessment must also include a rigorous comparison of purity and impurity profiles to ensure consistency with the originator product.

Overall, the analytical assays used in biosimilar development are designed to provide a robust basis for demonstrating similarity and ensuring that the biosimilar is safe and effective for clinical use.

References & Citations

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.