Anti-Human CD3 x CD19 Blinatumomab [Clone AMG103]
Anti-Human CD3 x CD19 Blinatumomab [Clone AMG103]
Product No.: C2530
Product No.C2530 Clone AMG103 Target CD3 x CD19 Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names CD3E: T-cell surface antigen T3/Leu-4 epsilon chain, T3E CD19: B-lymphocyte surface antigen B4, T-cell surface antigen Leu-12 Isotype Human IgG1κ Applications FA , FC , IP , WB |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Active Immunogen CD19 murine parental clone is HD37. CD3E murine parental clone is L2K-07. 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 biosimilar 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 -80°C. Avoid Repeated Freeze Thaw Cycles. Regulatory Status Research Use Only Country of Origin USA Shipping 2 – 8° C Wet Ice Additional Applications Reported In Literature ? FA, FC, IP, 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 Blinatumomab. Blinatumomab simultaneously binds human CD19 on B
cells and CD3E on T cells. Background Blinatumomab is a Bispecific T cell Engager (BiTE) antibody developed as a cancer immunotherapeutic drug1,2,3,4. Blinatumomab induces apoptosis of target B cells by binding simultaneously to the C19 surface antigen of all B cells (healthy and malignant) as well as the epsilon subunit of the CD3 invariant antigen of the T cell TCR (T cell receptor)4. Binding is achieved via two large single-chain variable fragments arranged in tandem, with the CD19-binding fragment at the N-terminal and the CD3 binding fragment at the C-terminal. The fragments are linked by a flexible, non-immunogenic, non-glycosylated five amino acid peptide (four glycine and one serine), which confers a high degree of rotational flexibility to facilitate simultaneous epitope binding. In this way, blinatumomab targets malignant B cells for apoptosis via CD19, a B-lymphocyte-specific receptor responsible for promoting activation and differentiation of normal B cells that functions as a costimulatory molecule of the B cell receptor2. Blinatumomab binding forces the colocalization of cytotoxic T lymphocytes and B cells expressing CD194. A structurally normal cytolytic immune synapse is formed, and, in T cells, activation events trigger the delivery of granzyme and perforin into the synaptic space, inducing apoptosis of the targeted B cells. Recruitment and activation of T cells occurs after the second arm of blinatumomab binds to the target cell antigen. An activated T cell can kill several B cells. Blinatumomab is a B lineage-specific antitumor mouse monoclonal antibody4. The CD19-targeting fragment is derived from the parental murine monoclonal antibody HD37, while the CD3-binding fragment is derived from the parental murine monoclonal antibody L2K-071,3,4. Blinatumomab is only one-third the size of traditional antibodies at 504 amino acids and a molecular weight of 55 kDa4. Other names for blinatumomab are MT103, MEDI‐538, bscCD19xCD3, and AMG103. Blinatumomab is a non-glycosylated fusion protein. Antigen Distribution CD19 is a surface antigen present on all B cells (healthy and malignant)
except hematopoietic stem cells and plasma cells; it is highly conserved in B-cell malignancies.
CD3E is a T cell surface glycoprotein. Ligand/Receptor CD3E: CD3D, CD3G, TCRalpha, TCRbeta, CD3Z CD19: B-cell antigen receptor complex, CR2/CD21, CD81, IFITM1/CD225, GRB2, SOS, PLCG2, LYN Research Area Adaptive Immunity . Apoptosis . Cancer . Immuno-Oncology 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 Blinatumomab biosimilars are used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA assays by providing a well-characterized, quantitative reference to generate a standard curve against which unknown drug concentrations in serum samples are measured. In PK ELISA assays specifically designed for Blinatumomab:
Critical points about using research-grade biosimilars as controls:
Summary Table: Role of Blinatumomab Biosimilars in PK Bridging ELISA
Using this approach, the ELISA can provide quantitative measurement of Blinatumomab in serum, essential for pharmacokinetic profiling and bridging studies. The primary models used to administer research-grade anti-CD3 x CD19 antibodies in vivo to study tumor growth inhibition and characterize tumor-infiltrating lymphocytes (TILs) are humanized xenografts and, less frequently, syngeneic models modified to enable CD19 targeting. Key model systems:
Summary Table:
Context on TIL analysis: References for further reading:
Researchers investigate synergistic anti-tumor effects by combining the Blinatumomab biosimilar—a bispecific antibody that engages CD3-positive T cells with CD19-expressing B-cell tumor cells—with other checkpoint inhibitors such as anti-CTLA-4 or anti-LAG-3 biosimilars, using preclinical and complex immune-oncology models to study how different immune pathways collaborate or compensate for each other. Key approaches and contexts:
Emerging biosimilars enable cost-effective study replication and exploration of personalized immunotherapy, though published results specifically using Blinatumomab biosimilars in combination with checkpoint inhibitor biosimilars are still limited. Summary Table
In summary: A blinatumomab biosimilar—a research-grade version of the therapeutic bispecific antibody—can be used as either the capture or detection reagent in a bridging anti-drug antibody (ADA) ELISA to monitor patient immune responses by detecting antibodies developed against blinatumomab or its biosimilar. How It Works in a Bridging ADA ELISA
Why a Biosimilar is Used
Assay Workflow Summary
Adaptations and Considerations
Context from the LiteratureThis approach—using a therapeutic antibody or biosimilar as both capture and detector in a bridging ELISA—is standard for ADA detection in biotherapeutics and has been reported for many monoclonal antibody drugs. For bispecific T-cell engagers (like blinatumomab), this method also allows the assessment of immunogenicity across both binding domains. In summary: A blinatumomab biosimilar is utilized as a capture or detection reagent in bridging ADA ELISA by immobilizing it on an assay plate (capture) and/or using a labeled version (detection) to identify patient-derived ADAs that bridge between the two, reflecting the immune response to blinatumomab therapy. References & Citations1 Löffler A, Kufer P, Lutterbüse R, et al. Blood. 95(6):2098-2103. 2000. 2 Portell CA, Wenzell CM, Advani AS. Clin Pharmacol. 5(Suppl 1):5-11. 2013. 3 Nagorsen D, Kufer P, Baeuerle PA, et al. Pharmacol Ther. Dec;136(3):334-342. 2012. 4 Mocquot P, Mossazadeh Y, Lapierre L, et al. J Clin Pharm Ther. 47(9):1337-1351. 2022. 5 Dreier T, Lorenczewski G, Brandl C, et al. Int J Cancer. 100(6):690-697. 2002. 6 Löffler A, Gruen M, Wuchter C, et al. Leukemia. 17(5):900-909. 2003. 7 Hoffmann P, Hofmeister R, Brischwein K, et al. Int J Cancer. 115(1):98-104. 2005. 8 Schlereth B, Quadt C, Dreier T, et al. Cancer Immunol Immunother. 55(5):503-514. 2006. 9 Mølhøj M, Crommer S, Brischwein K, et al. Mol Immunol. 44(8):1935-1943. 2007. 10 Brandl C, Haas C, d'Argouges S, et al. Cancer Immunol Immunother. 56(10):1551-1563. 2007. 11 Kantarjian H, Stein A, Gökbuget N, et al. N Engl J Med. 376(9):836-847. 2017. Technical ProtocolsCertificate of Analysis |
Formats Available
Prod No. | Description |
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C2530 | |
C2535 |
