Anti-Human EGFR (Cetuximab) [Clone C225] – Fc Muted™
Anti-Human EGFR (Cetuximab) [Clone C225] – Fc Muted™
Product No.: LT605
Product No.LT605 Clone C225 Target EGFR Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names ErbB-1; HER1; epidermal growth factor receptor Isotype Human IgG1κ Applications CyTOF® , FA , FC |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Muted Immunogen Human EGFR/ErbB1 Product Concentration ≥ 5.0 mg/ml Endotoxin Level < 1.0 EU/mg as determined by the LAL method Purity ≥95% by SDS Page ⋅ ≥95% monomer by analytical SEC Formulation This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration. State of Matter Liquid Product Preparation Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates. Pathogen Testing To protect mouse colonies from infection by pathogens and to assure that experimental preclinical data is not affected by such pathogens, all of Leinco’s recombinant biosimilar antibodies are tested and guaranteed to be negative for all pathogens in the IDEXX IMPACT I Mouse Profile. Storage and Handling Functional grade preclinical antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at ≤ -70°C. Avoid Repeated Freeze Thaw Cycles. Regulatory Status Research Use Only (RUO). Non-Therapeutic. Country of Origin USA Shipping 2-8°C Wet Ice RRIDAB_2893975 Applications and Recommended Usage? Quality Tested by Leinco FC The suggested concentration for Cetuximab biosimilar antibody for staining cells in flow cytometry is ≤ 0.25 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 CyTOF® 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 Cetuximab. This product is for research use only. Cetuximab activity is directed against Human EGFR. Background EGFR is a 170 kD transmembrane glycoprotein that is part of the ErbB family of receptors within the protein kinase superfamily. EGFR is one of four closely related receptor tyrosine kinases: EGFR (ErbB-1), HER2/c-neu (ErbB-2), Her 3 (ErbB-3) and Her 4 (ErbB-4). EGFR is essential for various processes including controlling cell growth and differentiation and ductal development of the mammary glands. Ligand binding induces dimerization and autophosphorylation. It consists of a glycosylated extracellular domain which binds to EGF and an intracellular domain with tyrosine-kinase activity necessary for signal transduction. TGFα, vaccinia virus growth factor, and related growth factors can also bind to and signal through EGFR. Abnormal EGFR signaling has been implicated in inflammatory diseases such as psoriasis, eczema and atherosclerosis. Alzheimer's disease is linked with poor signaling of the EGFR and other receptor tyrosine kinases. Furthermore, over-expression of the EGFR is linked with the growth of various tumors. EGFR has been identified as an oncogene, a gene which in certain circumstances can transform a cell into a tumor cell, which has led to the therapeutic development of anticancer EGFR inhibitors. EGFR is a well-established target for both mAbs and specific tyrosine kinase inhibitors. Anti-Human EGFR (Cetuximab) utilizes the same variable regions from the therapeutic antibody Cetuximab making it ideal for research projects. Antigen Distribution EGFR is ubiquitously expressed and found in the plasma membrane. 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 Cetuximab biosimilars are used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA assays to ensure accurate, reproducible measurement of drug concentration in serum samples by closely mimicking the reference product (such as Erbitux) and providing an analytically equivalent comparator. Essential Context and Supporting Details:
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Summary Table: Use of Research-Grade Cetuximab Biosimilars in PK Bridging ELISA
In summary: Research-grade Cetuximab biosimilars are routinely used as calibration standards or reference controls in PK bridging ELISA, enabling accurate measurement of drug concentrations in serum by serving as analytically equivalent substitutes to the original reference product. The primary models for studying research-grade anti-EGFR antibodies in vivo for tumor growth inhibition and TIL characterization fall into several key categories, though the available literature shows more development in certain areas than others. Syngeneic ModelsMelanoma ModelsA notable advancement is the development of the first mouse syngeneic melanoma model with preserved in vivo expression of human EGFR. This model addresses a critical gap in research, as most existing syngeneic models either lack melanoma origin or don't express human EGFR, which is essential for testing anticancer agents that specifically recognize human receptors. Other Established Syngeneic LinesSeveral tumorigenic mouse cell lines expressing significant EGFR levels have been utilized for in vivo studies, including hepatocellular carcinoma CBO140C12, metastatic Lewis lung carcinoma variant 3LLD122, mouse breast carcinoma 4T1, and mouse colon carcinoma CT26. However, availability and quality control issues limit some of these models, and EGFR expression levels can vary significantly between studies. Glioblastoma ModelsSyngeneic C57BL/6 mice have been successfully used for glioblastoma studies, where CAR T cells targeting NKG2D (rather than EGFR directly) demonstrated the ability to migrate to tumor sites, increase survival, and cure a fraction of glioma-bearing mice. This model's success led to human clinical trials, demonstrating the translational potential of well-designed syngeneic studies. Xenograft ModelsA431 Cell Line StudiesThe most detailed characterization comes from studies using A431-derived solid tumors in athymic nude mice. In these studies, anti-EGFR Nanobodies were administered at high doses (1 mg per mouse per injection, twice weekly for 4 weeks) and successfully demonstrated significant delays in tumor outgrowth. This represents the first reported successful use of unconjugated Nanobodies to inhibit solid tumor growth in vivo. Human Colon Cancer XenograftsRAS wild-type human colon cancer xenografts serve as relevant models for EGFR inhibitor-sensitive tumors, particularly for studying triple monoclonal antibody approaches. Key Considerations for Model SelectionImmunocompetent vs. Immunocompromised SystemsSyngeneic models offer the advantage of a fully functional immune system, which is crucial for evaluating immune checkpoint inhibitor efficacy and characterizing tumor-immune interactions. These models are particularly valuable for understanding TIL dynamics, as they preserve the natural immune microenvironment that influences T cell infiltration and activation. Species-Specific Receptor ExpressionA significant challenge in anti-EGFR research is that many established syngeneic models lack human EGFR expression, limiting their utility for testing human-specific therapeutic antibodies. The development of transgenic approaches using genetic knock-in of human antigens into murine cells represents a promising solution. Functional Validation RequirementsEffective models require not just EGFR expression but also functional responsiveness to EGF signaling. The most successful approaches have utilized functional selection strategies to identify antibodies that compete for EGF binding and effectively block downstream signaling pathways. The field continues to evolve toward more sophisticated syngeneic models that combine human target expression with intact immune systems, enabling comprehensive evaluation of both direct anti-tumor effects and immune-mediated responses including TIL characterization. Researchers use Cetuximab biosimilars in combination with immune checkpoint inhibitors (ICIs), such as anti-CTLA-4 or anti-LAG-3 biosimilars, to explore synergistic antitumor effects in complex immune-oncology models by leveraging their complementary mechanisms to recruit and activate immune cells and to relieve immunosuppressive checkpoints. Key mechanisms of synergy and research approaches include:
Immunogenicity and Biosimilar Considerations:
Summary Table: Cetuximab + Checkpoint Inhibitors Research Focus
Thus, Cetuximab biosimilars in combination with anti-CTLA-4 or anti-LAG-3 biosimilars are investigated in immune-oncology models to dissect and enhance the multiple layers of anti-tumor immunity, mainly by escalating both innate and adaptive immune responses while blocking adaptive resistance mechanisms. Ongoing clinical and translational studies aim to refine these combinations and validate their safety, immune impact, and clinical benefit. In a bridging ADA ELISA for immunogenicity testing of a Cetuximab biosimilar, the biosimilar is used both as the capture and detection reagent to specifically detect anti-drug antibodies (ADAs) generated against Cetuximab in patient serum. Assay Principle and Workflow:
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This approach is standard for ADA monitoring across various monoclonal antibody therapies, with the biosimilar substituting wherever regulatory and analytical comparability have been established. References & Citations1. Tortora, G. et al. (1999) Clin Cancer Res. 5(4):909-16. 2. Myers, J. et al. (2006) Clin Cancer Res. 12(2): 600–607. Technical ProtocolsCertificate of Analysis |
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