Anti-Human CD52 (Alemtuzumab) – Dylight® 488
Anti-Human CD52 (Alemtuzumab) – Dylight® 488
Product No.: LT211
Product No.LT211 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 FA , FC , IHC FF , IHC FFPE |
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 0.2 mg/ml Formulation This DyLight® 488 conjugate 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 DyLight® 488 conjugate 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 Excitation Laser Blue Laser (493 nm) RRIDAB_2893946 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 ? IHC FFPE (Formalin-fixed paraffin-embedded tissue) IHC FF (Fresh Frozen) FA 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 are used as calibration standards and reference controls in PK bridging ELISA assays to establish accurate, reproducible measurement of alemtuzumab concentration in serum samples. These biosimilar standards provide a quantifiable reference curve for unknown patient samples and quality controls throughout assay validation and sample analysis. Key details on their application in PK ELISA:
Summary of workflow:
In essence, research-grade alemtuzumab biosimilars serve as both calibration standards for quantitative PK analysis and as reference controls to validate assay accuracy, precision, and comparability across batches and studies. When using a conjugated Alemtuzumab biosimilar (e.g., PE or APC-labeled) in flow cytometry to validate the expression levels or binding capacity of the CD52 target, the following standard protocols are typically involved: Protocol Overview
Additional Considerations
Example Code for Flow Cytometry SettingsWhile specific code varies by software, here is a general idea of how to set up in FCSExpress:
This is a simplified example and actual code will depend on the specific software and hardware used for flow cytometry analysis. Use of QuantiBRITE BeadsQuantiBRITE PE Beads are used to construct a standard curve relating fluorescence intensity to the number of PE molecules per cell. This allows for the quantification of the antibody binding capacity (ABC) per cell.
Biopharma companies employ a comprehensive suite of analytical assays to establish the structural and functional similarity of proposed biosimilars to their reference products. This analytical similarity assessment forms the foundation of biosimilar development and regulatory approval. Structural Characterization AssaysPhysicochemical Properties Analysis encompasses primary, secondary, and higher-order structural assessments. These studies include detailed peptide mapping to evaluate amino acid sequences, mass spectrometry techniques to assess molecular weight and structural integrity, and chromatographic methods to examine protein folding patterns. Post-Translational Modifications are critically evaluated through specialized analytical techniques. Companies assess glycosylation profiles, deamidation patterns, oxidation states, and other chemical modifications that occur during protein production. These modifications can significantly impact the biological activity and safety profile of the biosimilar. Impurity Profiling involves comprehensive assessment of both process-related and product-related impurities. Mass spectrometry and chromatographic techniques are deployed to evaluate impurity profiles, including aggregates, precursors, fragments, and other modified forms that may be present in the biosimilar compared to the reference product. Functional Characterization AssaysBiological Potency Assessments represent the crucial link between structural similarity and clinical expectation. These assays answer whether minor structural differences observed during characterization have any functional significance. Cell-based assays are employed to measure the biological activity of the biosimilar in comparison to the reference product. Binding Assays constitute a critical component of functional testing. For monoclonal antibodies, Fc receptor binding assays demonstrate whether the biosimilar binds with equivalent affinity to key immune receptors like FcγRIIIa, even if slight glycosylation differences exist. Target binding assays confirm that the biosimilar maintains the same binding specificity and affinity as the originator drug. Enzyme Kinetics studies are performed for biosimilars with enzymatic activity, measuring catalytic efficiency, substrate binding, and reaction rates to ensure functional equivalence. Analytical Strategy and Risk AssessmentOrthogonal Methods are extensively utilized to provide complementary data and enhance the confidence in similarity assessments. Manufacturers apply multiple analytical techniques to better characterize molecular properties and more sensitively assess potential differences between the biosimilar and reference product. Risk-Based Approach guides the analytical strategy, where molecular properties are ranked by their potential impact on activity, pharmacokinetics, pharmacodynamics, safety, efficacy, or immunogenicity. Critical quality attributes receive particular focus based on the protein's nature and mechanism of action. Head-to-Head Comparisons are conducted across multiple lots of both the proposed biosimilar and reference product, with results required to fall within appropriate limits, ranges, or distributions. This approach ensures statistical robustness in the similarity assessment. Regulatory FrameworkThe analytical characterization programs are based on criteria outlined in ICH Q6B guidelines. These comprehensive assessments must demonstrate that the biosimilar and reference product are "highly similar" with no clinically meaningful differences. The analytical data serves as the foundation for reducing the clinical trial burden typically required for new biological entities, making biosimilars more accessible and affordable. Regarding the specific use of Leinco biosimilar in these studies, the search results do not contain information about this particular biosimilar product. The analytical methods and approaches described above represent the standard industry practices applied to all biosimilar development programs, regardless of the specific manufacturer or product name. References & CitationsTechnical ProtocolsCertificate of Analysis |
Formats Available
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LT200 | |
LT203 | |
LT204 | |
LT202 | |
LT201 | |
LT211 | |
LT206 | |
LT205 | |
LT207 |
