Anti-Human CD52 (Alemtuzumab) – Biotin
Anti-Human CD52 (Alemtuzumab) – Biotin
Product No.: LT201
Product No.LT201 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 |
Antibody DetailsProduct DetailsReactive 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 Biotinylated antibody is formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.4, 1% BSA and 0.09% sodium azide as a preservative. Storage and Handling This biotinylated 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 RRIDAB_2893938 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. DescriptionDescriptionSpecificity 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 UniProt.org Research Area Biosimilars Leinco Antibody AdvisorPowered 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 alemtuzumab biosimilars serve as critical calibration standards and reference controls in pharmacokinetic bridging ELISA assays through a carefully validated approach that ensures accurate quantification of drug concentrations in serum samples. Calibration Standard Preparation and ValidationIn pharmacokinetic bridging ELISAs, alemtuzumab biosimilars are prepared as calibration standards using multiple batches to establish reliability. Research has demonstrated that three different alemtuzumab calibration standards from different batches are compared to exclude concentration differences between batches, with accuracy ranging from 91% to 104%. The calibration standards are typically prepared in neat pooled human serum to match the matrix of clinical samples. Dynamic Range and Sensitivity RequirementsThe calibration standards establish a dynamic range that accommodates the expected therapeutic concentration range. For alemtuzumab ELISA assays, the dynamic range typically spans from 0.78 to 25 ng·mL⁻¹, with a lower limit of quantification (LLoQ) of 0.5 ng·mL⁻¹. This sensitivity range is crucial for measuring both peak concentrations and concentrations below the lympholytic level (<0.1 mcg·mL⁻¹), requiring patient serum samples to be prediluted 20-400 times according to expected alemtuzumab concentrations. Quality Control and ReproducibilityBatch-to-Batch Consistency: Multiple biosimilar batches are used as reference standards to validate consistency across different production lots. Complete calibration curves are measured multiple times over extended periods to analyze reproducibility based on precision (coefficient of variation) and accuracy compared to theoretical concentrations. Performance Specifications: The calibration standards must meet stringent accuracy and precision criteria, with overall within-run accuracy between 96% and 105%, and within-run precision (coefficient of variation) between 3% and 9%. Between-run assessments provide overall accuracy between 86% and 95% and coefficient of variation between 5% and 14%. Anti-Idiotypic Antibody ApproachModern biosimilar ELISA assays employ anti-idiotypic monoclonal antibodies in a sandwich assay format, which provides exceptional specificity and sensitivity in drug detection, even at low concentrations. These assays are calibrated against innovator drugs to ensure high accuracy, with standards provided in kits that are calibrated against commercially sourced drugs and alternate recombinant biosimilars. Regulatory Compliance and ValidationThe use of biosimilar calibration standards follows strict regulatory guidelines, with validation performed according to European Medicines Agency (EMA) guidelines on bioanalytical method validation. Commercial assays are validated against ICH/EMA guidelines under ISO 13485 certification, ensuring inter and intra-assay coefficients of variation remain below 10% in accordance with FDA and EMEA requirements. Matrix Effect ConsiderationsTo ensure no matrix interference and reproducible dilutional linearity, multiple serum and plasma spiking experiments are conducted at various dilutions during optimization. This approach validates that the biosimilar standards perform consistently across different sample types and dilution factors, which is essential for accurate pharmacokinetic analysis in clinical samples. The integration of research-grade alemtuzumab biosimilars as calibration standards enables precise therapeutic drug monitoring and pharmacokinetic analysis, providing clinicians with the accurate concentration data needed to optimize treatment strategies and dosing regimens. Standard flow cytometry protocols using a conjugated Alemtuzumab biosimilar (such as PE, APC, or Alexa Fluor 647-labeled) to validate CD52 expression levels or binding capacity typically follow these structured steps:
Key technical details drawn from protocols:
Fluorochrome Options:
Use-case examples:
References to standard protocols and datasheets:
In summary: Biopharma companies perform a comprehensive suite of analytical assays to demonstrate that a proposed biosimilar is structurally and functionally similar to its originator drug. These include rigorous comparative studies of physicochemical properties, structural features, post-translational modifications, impurity profiles, and a range of functional (biological) assays. Analytical Assays for Biosimilar CharacterizationStructural Characterization:
Functional Characterization:
Orthogonal and Risk-Based Approaches:
Role of Leinco Biosimilars in Analytical StudiesLeinco Technologies provides research-grade biosimilar antibodies and reagents often used as surrogates or standards within biosimilar analytical comparability programs.
In summary, the typical analytical strategy combines extensive physicochemical, structural, and functional testing with sensitive, validated methods; Leinco biosimilars play a supporting role in assay calibration and development but are not a substitute for head-to-head analytical assessment with the regulatory reference (originator) product. References & CitationsTechnical ProtocolsCertificate of Analysis |
Formats Available
Prod No. | Description |
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LT200 | |
LT203 | |
LT204 | |
LT202 | |
LT201 | |
LT211 | |
LT206 | |
LT205 | |
LT207 |
