Anti-Human CD20 (Rituximab) [Clone 10F381] — Fc Muted™
Anti-Human CD20 (Rituximab) [Clone 10F381] — Fc Muted™
Product No.: LT905
Product No.LT905 Clone 10F381 Target CD20 Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Rituximab, CD20, MS4A1, Isotype Human IgG1κ Applications ELISA , FA , FC , IP , WB |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Muted Immunogen Human CD20 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. 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_2894035 Additional Applications Reported In Literature ? ELISA, 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 Rituximab. Clone 10F381 recognizes human CD20. This product is for research use only. Background CD20 is a nonglycosylated 33-37 kDa transmembrane-spanning phosphoprotein that is a member of the MS4A family which is widely expressed on normal B cell surfaces during all stages of development as well as by most B cell malignancies1, 2. The biological role of CD20 remains poorly understood; however, it is thought to be involved in calcium ion influx. CD20 has no natural ligand and is not immediately internalized upon antibody binding. Thus, mAbs directed against CD20 depend on the recruitment of a host response. CD20 is a popular target for mAb therapy because depleting developing B-cells generally does not cause permanent side effects (due to the fact that mature plasma cells and B-cell progenitors do not express CD20 and that there is limited expression of CD20 among other cell lineages).
Rituximab is a chimeric monoclonal antibody that binds to CD20. Rituximab is used to treat some autoimmune diseases and types of cancer such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis among others. The Fc portion of Rituximab mediates antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Rituximab increases MHC II and adhesion molecules LFA-1 and LFA-3 (lymphocyte function-associated antigen) and also induces apoptosis of CD20+ cells. This ultimately results in the elimination of B cells (including the cancerous ones) from the body, and thus allows a new population of healthy B cells to develop from lymphoid stem cells. Anti-Human CD20 (Rituximab) utilizes the same variable regions from the therapeutic antibody Rituximab making it ideal for research projects. Antigen Distribution CD20 is primarily found on the surface of immune system B cells. CD20 is highly expressed in the lymph node, and to a lesser extent, the spleen and appendix. Ligand/Receptor Src family tyrosine kinases, MHC class I, II, CD53, CD81, CD82 PubMed NCBI Gene Bank ID UniProt.org Research Area Biosimilars . Cancer . Immuno-Oncology . Immunology 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. Use of Research-Grade Rituximab Biosimilars as Calibration Standards in PK Bridging ELISAPharmacokinetic (PK) bridging ELISA is a standard method for quantifying therapeutic monoclonal antibodies like rituximab in serum, supporting both original and biosimilar development. Here’s how research-grade biosimilars function as calibration standards or reference controls in these assays: Calibration and Reference Role of Biosimilars
Assay Validation and Biosimilar Equivalence
Practical Protocol for PK Bridging ELISAA typical PK bridging ELISA protocol involves:
The detection range is broad (e.g., 0.1–1,000 ng/ml) to cover expected serum levels post-administration. Standards, whether originator or biosimilar, should cover this full range, including a zero concentration for background subtraction. Summary Table: Key Aspects of Using Biosimilars as Standards
ConclusionResearch-grade rituximab biosimilars, when analytically validated, are routinely used as calibration standards and reference controls in PK bridging ELISAs to measure drug concentration in serum samples. They must demonstrate equivalence to the originator in critical assay performance parameters and can be cross-referenced to international standards for traceability. This approach supports robust, comparable pharmacokinetic assessments for both originator and biosimilar rituximab products in clinical and research settings. The primary in vivo models for studying the effects of research-grade anti-CD20 antibody on tumor growth inhibition and characterization of tumor-infiltrating lymphocytes (TILs) are predominantly syngeneic mouse tumor models engineered to express human CD20, as well as fully murine models using species-specific anti-CD20 antibodies. Key model types:
Syngeneic vs. Humanized Model Comparison Table
Supporting Details:
In summary, syngeneic mouse models engineered to express human CD20 are the principal preclinical systems for in vivo administration of research-grade anti-CD20 antibodies to analyze tumor growth and TILs. Humanized models are occasionally used for higher translational relevance but are less frequently reported in these mechanistic studies. Researchers use Rituximab biosimilars alongside other checkpoint inhibitors such as anti-CTLA-4 or anti-LAG-3 biosimilars to study potential synergistic effects in complex immune-oncology models by employing combination strategies that target both B cell-mediated immunity (via CD20) and T cell regulation (via immune checkpoints). Key approaches and supporting details:
Limitations and considerations:
Summary Table: Rituximab Biosimilar + Checkpoint Inhibitor Combination
This combinatorial approach allows researchers to test hypotheses about synergistic anti-tumor immunity arising from simultaneous targeting of both arms of the immune system—B cells and T cells—using cost-effective, research-grade biosimilars as surrogates for clinical antibodies. A Rituximab biosimilar is commonly used in a bridging anti-drug antibody (ADA) ELISA as both the capture and detection reagent to specifically identify patient-generated antibodies against the therapeutic drug (Rituximab or its biosimilar). In a typical bridging ADA ELISA for Rituximab:
Why a Rituximab biosimilar is used:
This format is especially sensitive because ADAs are typically bivalent, permitting the “bridging” formation necessary for detection. Importantly, this method can distinguish between true anti-drug antibodies and other serum components, provided appropriate controls and specificity reagents are included. In summary, a Rituximab biosimilar serves as the key antigen in the bridging ADA ELISA: immobilized on the plate for capture and labeled for detection, enabling identification and quantitation of patient antibodies against the therapeutic Rituximab. References & Citations1. Middleton O, Wheadon H, Michie AM. Classical Complement Pathway. In MJH Ratcliffe (Ed.), Reference Module in Biomedical Sciences Encyclopedia of Immunobiology Volume 2 (pp. 318-324). Elsevier. 2016.
2. Freeman CL, Sehn LH. Br J Haematol. 182(1):29-45. 2018. 3. Mato, A. et al. (2018) Oncologist. 23(3):288-296. 4. Richards, K. et al. (2018) Front Oncol. 8: 163. Technical ProtocolsCertificate of Analysis |
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