Anti-Human CD52 (Alemtuzumab) – Fc Muted™ HRP
Anti-Human CD52 (Alemtuzumab) – Fc Muted™ HRP
Product No.: LT207
Product No.LT207 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 Muted 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 RRIDAB_2893945 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 are used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA by preparing serial dilutions of the biosimilar in human serum or plasma to create a calibration curve, which is then used to quantify alemtuzumab concentrations in patient samples through comparison with these standards. Essential context and details:
Additional Relevant Information:
In summary, biosimilar-grade Alemtuzumab standards act as crucial calibration and control reagents in PK ELISA protocols, anchoring quantification and assay validation by matching lot, matrix, and concentration characteristics to those expected in real-world serum samples. Biopharma companies employ a comprehensive battery of analytical assays to confirm both structural and functional similarity between proposed biosimilars and their reference products. This analytical characterization forms the foundation of biosimilar development and regulatory approval. Structural Similarity AssaysThe structural characterization begins with primary amino acid structure analysis to confirm sequence identity between the biosimilar and reference product. Companies utilize advanced analytical techniques including circular dichroism and nuclear magnetic resonance spectroscopies to analyze higher-order protein structure. Peptide mapping serves as a crucial tool for detecting structural differences, particularly in glycosylation profiles between products. Mass spectrometry and other orthogonal methods are employed to identify posttranslational modifications, which can significantly impact protein function. Manufacturers also conduct rigorous purity and impurity profiling to ensure comparable quality between the biosimilar and reference product. The analytical approach involves head-to-head comparisons using multiple lots of both the proposed biosimilar and reference product, with results required to fall within appropriate limits, ranges, or distributions. Companies often apply multiple complementary techniques or orthogonal methods to better characterize molecular properties and more sensitively assess for potential differences. Functional Similarity AssaysFunctional assays serve as the crucial link between structural data and clinical expectations, answering whether any observed structural differences translate into functional significance. These assays fall into two primary categories: Binding Assays evaluate the biosimilar's ability to bind to its intended target with equivalent affinity. For monoclonal antibodies, this includes Fc receptor binding assays that assess binding to key immune receptors like FcγRIIIa. These assays can demonstrate that even minor structural differences, such as slight variations in glycosylation profiles, do not impact functional performance. Potency Assays measure the biological activity and mechanism-of-action bioassays that evaluate the drug's intended therapeutic function. Enzyme kinetics studies assess the catalytic activity of therapeutic enzymes, while other biological assays evaluate various functional endpoints relevant to the specific therapeutic protein. Risk-Based Approach to TestingManufacturers rank molecular properties by their risk of impact to the product's activity, pharmacokinetics and pharmacodynamics, safety, efficacy, or immunogenicity. This risk assessment determines which attributes are most critical for demonstrating biosimilarity, with particular focus placed on properties based on the protein's nature and mechanism of action. The analytical studies must demonstrate that the proposed biosimilar and reference product are highly similar, with any structural differences shown to be functionally insignificant through comprehensive functional testing. This extensive characterization of the reference product establishes the standards against which the proposed biosimilar is evaluated. Regarding the Leinco biosimilar specifically, the provided search results do not contain information about this particular product or its use in analytical studies. The analytical methods described represent general industry standards applied across all biosimilar development programs to establish the totality of evidence required for regulatory approval. References & CitationsTechnical ProtocolsCertificate of Analysis |
Formats Available
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LT200 | |
LT203 | |
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LT201 | |
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LT206 | |
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LT207 |
