Anti-Human HER-2 (Trastuzumab) – Dylight® 488
Anti-Human HER-2 (Trastuzumab) – Dylight® 488
Product No.: LT1511
Product No.LT1511 Clone 4D5-8 Target HER-2/neu Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names ErbB-2, NEU, NGL, HER2, TKR1, CD340, MLN 19, HER-2/neu Isotype Human IgG1κ Applications FC , IHC |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Active Immunogen Human epidermoid carcinoma cells (A431) over-expressing EGFR. 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_2893918 Applications and Recommended Usage? Quality Tested by Leinco FC The suggested concentration for Trastuzumab 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 Additional Reported Applications For Relevant Conjugates ? CyTOF® ELISA 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 Trastuzumab. Clone 4D5-8 recognizes human erbB-2. This product is for research use only. Background Trastuzumab is a monoclonal antibody targeting HER2, a 185 kDa transmembrane glycoprotein that contains an extracellular domain and intracellular tyrosine kinase activity. When it is functioning normally, the HER2 pathway supports cell growth and division. On the other hand, the over expression of HER2 propels cell growth beyond its typical range. This overexpression is associated with some cancers, namely breast and stomach, in which the HER2 protein can be expressed up to 100 times more than in typical cells. Trastuzumab induces an immune-mediated response that triggers the internalization and downregulation of HER2 making it an excellent target for immunotherapy. Several clinical studies are under way which show that anti-HER-2/neu antibodies inhibit the growth and proliferation of these tumor cells In vitro as well as In vivo. Antigen Distribution Ubiquitous expression with highest expression levels found in the kidney, skin, esophagus, and small intestine. 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 Trastuzumab biosimilars are used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA by serving as the quantitative reference against which drug concentrations in serum samples are measured and compared. This approach allows direct and accurate measurement of both the biosimilar and reference trastuzumab (originator) products within the same assay, ensuring consistency and minimizing analytical variability. Context and Supporting Details:
Summary of Best Practice:
This approach allows accurate, precise, and regulatory-compliant measurement of drug concentrations throughout biosimilar development and clinical testing. Standard flow cytometry protocols that use a PE- or APC-conjugated Trastuzumab biosimilar for validating HER-2/neu expression or binding capacity typically follow these steps:
Key Protocol Example (from literature)
Applications & Notes
In summary: The standard flow cytometry protocol is based on cell surface staining with PE/APC-labeled Trastuzumab biosimilar, proper controls, and MFI quantitation for HER2 expression or antibody binding assessment. Each lab may optimize conditions for their particular cell system and application. Biopharma companies employ a comprehensive battery of analytical assays to establish that a proposed biosimilar is highly similar to the reference originator drug. This analytical similarity assessment serves as the foundation for biosimilar approval and focuses on demonstrating structural and functional equivalence through rigorous comparative testing. Structural Characterization AssaysThe structural analysis begins with primary structure assessment, which includes testing for similarity in amino acid sequence and composition. Companies utilize advanced analytical techniques such as circular dichroism and nuclear magnetic resonance spectroscopies to analyze higher-order protein structure, ensuring the biosimilar maintains the same three-dimensional conformation as the reference product. Posttranslational modification detection represents another critical component, as these modifications can significantly impact protein function. This includes comprehensive analysis of glycosylation patterns, deamidation, oxidation, and other chemical modifications that occur during protein processing. Peptide mapping techniques are commonly employed to identify and quantify these modifications, with any differences requiring careful evaluation of their potential clinical significance. Functional Characterization AssaysFunctional testing serves as the crucial bridge between structural data and clinical expectations, answering whether any observed structural differences translate into meaningful biological impact. The functional characterization program encompasses multiple orthogonal assays designed to probe all known biological activities of the molecule. Binding assays constitute a fundamental component, particularly for monoclonal antibodies and other target-specific biologics. These assays evaluate the biosimilar's ability to bind to its intended target with equivalent affinity compared to the reference product. For antibody-based therapeutics, this includes Fc receptor binding assays that assess interaction with immune system receptors like FcγRIIIa. Potency assays measure the biological activity and functional capacity of the biosimilar. These typically include enzyme kinetics studies for enzyme-based therapeutics, cell-based assays for growth factors and cytokines, and other functional readouts specific to the molecule's mechanism of action. Purity and Impurity AssessmentThe analytical similarity assessment must include rigorous comparison of purity and impurity profiles between the biosimilar and reference product. This involves testing for aggregates, precursors, fragments, and other modified forms that may represent product-related variants. Companies analyze both the types and levels of impurities to ensure they fall within acceptable ranges established by the reference product. Analytical Strategy and Data IntegrationManufacturers typically employ multiple complementary analytical techniques or orthogonal methods to comprehensively characterize both products and support conclusions of high similarity. The molecular properties identified through these assays are ranked by their risk of impact on the product's activity, pharmacokinetics, pharmacodynamics, safety, efficacy, or immunogenicity. This risk-based approach helps identify critical quality attributes (CQAs) that require particular focus during the biosimilarity assessment. The analytical studies involve head-to-head comparisons where results must fall within appropriate limits, ranges, or distributions established through extensive characterization of the reference product. Highly sensitive analytical methods enable measurement of molecular properties across multiple lots of both the proposed biosimilar and reference product, providing robust statistical comparisons. Regarding the Leinco biosimilar specifically mentioned in your query, the provided search results do not contain information about this particular biosimilar or its use in analytical studies. The search results focus on general principles and methodologies for biosimilar analytical characterization rather than specific commercial products or case studies involving Leinco biosimilars. References & Citations1. Fendly, B. et al. (1990) Cancer Research 50: 1550-1558. 2. McBride, H. et al. (2019) Pharm Res. 36(12): 177. 3. Zielinski, C. et al. (1997) Int. J. Cancer 73: 875–879 4. Valone, FH. et al. (1995) J. Clin. Oncology 13 (9): 2281-92. 5. Hynes, NE. et al. (1993) Br J Cancer. 68(6): 1140–1145. Technical ProtocolsCertificate of Analysis |
Formats Available
Prod No. | Description |
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LT1500 | |
LT1508 | |
LT1503 | |
LT1504 | |
LT1502 | |
LT1501 | |
LT1511 | |
LT1506 | |
LT1505 | |
LT1507 |
