Anti-Human CD257 (BAFF) (Tabalumab) – Fc Muted™
Anti-Human CD257 (BAFF) (Tabalumab) – Fc Muted™
Product No.: LT1405
Product No.LT1405 Clone Tabalumab Target BAFF Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Tabalumab, CD257, BAFF, TNFSF13b, BLYS Isotype Human IgG1κ Applications ELISA , FA , FC , IF , IP , N , WB |
Antibody DetailsProduct DetailsReactive Species Cynomolgus Monkey ⋅ Human ⋅ Rabbit Host Species Human Expression Host HEK-293 Cells FC Effector Activity Muted Immunogen Original antibody was raised against soluble human BAFF. 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_2893906 Additional Applications Reported In Literature ? FA N IP WB ELISA IF 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 Tabalumab. Tabalumab neutralizes soluble human, cynomolgus monkey, and rabbit BAFF. Additionally, Tabalumab neutralizes membrane-bound BAFF. This product is for research use only. Background Tabalumab is a human monoclonal anti-B-cell activating factor (BAFF) antibody intended for the treatment of autoimmune diseases and B cell malignancies.1 BAFF is a membrane-bound, type II transmembrane protein that belongs to the tumor necrosis factor (TNF) ligand family and is the ligand for BR3, TACI, and BCMA. BAFF is an immunostimulant necessary for maintaining normal immunity. This cytokine has also been shown to play an important role in the proliferation and differentiation of B cells. An inadequate level of BAFF leads to immunodeficiency whilst an elevated level of BAFF causes unusually high antibody production that results in the development of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. Additionally, BAFF has been found in renal transplant biopsies with acute rejection.2 Furthermore, BAFF may be a mediator of food-related inflammation, and is associated with multiple dietary ailments including celiac disease, insulin resistance, diabetes, and obesity.3 Interestingly, it is suspected that BAFF may be involved in non-IgE-mediated reactions because there is no known correlation between BAFF and IgE.4 More research is needed to unlock the enormous therapeutic potential for BAFF antagonists. This cost-effective, research-grade Anti-Human CD257 (BAFF) (Tabalumab) utilizes the same variable regions from the therapeutic antibody Tabalumab making it ideal for research projects. Antigen Distribution BAFF is expressed on various cell types including monocytes, dendritic cells and bone marrow stromal cells. Ligand/Receptor TACI, BCMA,APRIL ligand, BAFFR/BR3 PubMed NCBI Gene Bank ID UniProt.org Research Area Biosimilars . Cancer . Cell Biology . Costimulatory Molecules . Immuno-Oncology . Immunology . Signal Transduction . Stem Cell 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 Tabalumab biosimilars serve critical roles as calibration standards and reference controls in pharmacokinetic bridging ELISAs through a scientifically rigorous approach that ensures accurate and reliable drug concentration measurements in serum samples. Single Assay Methodology Using Biosimilar StandardsThe optimal bioanalytical strategy employs a single PK assay approach using a unified analytical standard for quantitative measurement of both biosimilar and reference products. This methodology offers significant advantages by decreasing inherent variability associated with multiple testing methods and eliminating the need for crossover analysis during blinded clinical studies. The approach begins with a comprehensive method qualification study that generates precision and accuracy data sets for both biosimilar and reference products, followed by statistical analysis to determine bioanalytical equivalence within the method. Calibration Standards and Quality Control PreparationFor Tabalumab PK assays, calibration standards are prepared using validated ELISA methodology with specific concentration ranges optimized for therapeutic monitoring. The standard curves typically include nine independent concentration points, such as 50, 100, 200, 400, 800, 1600, 3200, 6400, and 12800 ng/mL, prepared in human serum matrix. These standards undergo rigorous validation across multiple assays performed over several days by different analysts to ensure reproducibility and accuracy. Quality control samples are prepared independently using both biosimilar and reference products at strategic concentrations including low (50 ng/mL), medium (150 ng/mL and 1250 ng/mL), and high (9600 ng/mL and 12800 ng/mL) levels. These QC samples serve as internal references to monitor assay performance and detect any drift or systematic errors during sample analysis. Bridging ELISA Configuration and DetectionThe bridging ELISA format utilizes capture and detection antibodies specifically designed to recognize Tabalumab while avoiding cross-reactivity with other therapeutic antibodies or endogenous proteins. The assay employs validated enzyme-linked immunosorbent methodology with defined lower and upper limits of quantification, typically ranging from 25 ng/mL to 800 ng/mL for Tabalumab measurements. Inter-assay precision and accuracy parameters are rigorously established during validation, with acceptable ranges for relative error (-15.2% to 5.97%) and relative standard deviation (4.41% to 19.8%). This ensures consistent performance across different analytical runs and operators. Bioanalytical Equivalence AssessmentThe biosimilar standards undergo bioanalytical comparability testing to demonstrate equivalence with reference products. Statistical analysis compares 90% confidence intervals to predefined equivalence criteria [0.8, 1.25], combining multiple lines of evidence to establish bioanalytical equivalence. This stringent approach minimizes confounding variability and ensures the method's suitability for supporting PK similarity studies. Practical Implementation in Sample AnalysisDuring routine sample analysis, the biosimilar-derived calibration curve serves as the quantitative backbone for determining Tabalumab concentrations in unknown serum samples. Each analytical run includes freshly prepared standards, quality control samples at multiple concentration levels, and study samples, all processed under identical conditions to ensure data integrity. The validated method demonstrates high specificity with no cross-reactivity to other therapeutic monoclonal antibodies or endogenous serum proteins, ensuring accurate measurement of free, biologically active Tabalumab concentrations. This specificity is particularly important for therapeutic drug monitoring where multiple biologics may be present in patient samples. This comprehensive bioanalytical framework enables reliable pharmacokinetic characterization of Tabalumab biosimilars, providing the concentration-time data essential for demonstrating bioequivalence and supporting regulatory submissions for biosimilar drug development. Based on the research literature, both syngeneic and humanized models are utilized for studying anti-BAFF antibody effects on tumor growth and tumor-infiltrating lymphocytes, though the specific model choice depends on the research objectives and the particular anti-BAFF antibody being investigated. Syngeneic Models for Anti-BAFF StudiesSyngeneic tumor models represent the primary approach for evaluating anti-BAFF antibodies in immunocompetent settings. These models are particularly valuable because they maintain a fully functional immune system that closely mimics the natural tumor-immune interactions seen in human disease. The key advantages of syngeneic models for anti-BAFF research include their ability to evaluate immune checkpoint inhibitor efficacy and provide comprehensive analysis of how treatments interact with the immune system to target cancer cells. These models are especially beneficial for developing and testing immunotherapeutic agents, as they offer detailed insights into tumor-infiltrating lymphocyte populations and their responses to BAFF inhibition. Common syngeneic models used in this research include well-characterized systems like MC38 and more challenging models such as TC-1, which are fully characterized for gene expression, baseline TIL populations, and responses to common immune modulators. Humanized Models and Clinical ApplicationsWhile the search results don't provide extensive detail on humanized models specifically, clinical studies with anti-BAFF antibodies like belimumab and atacicept have demonstrated significant effects on human B cell populations. These studies show that BAFF inhibition results in rapid expansion of the memory B cell pool in humans, though the mechanism behind this phenomenon remains under investigation. Mechanistic Considerations for Model SelectionThe choice between syngeneic and humanized models often depends on the specific BAFF receptor interactions being studied. BAFF interacts with multiple receptors including BAFF-R, TACI, and BCMA, each with distinct roles in B cell biology and survival. For studies focusing on membrane-bound BAFF inhibition, both model types can be informative, as research has shown that anti-BAFF antibodies like belimumab and atacicept can effectively inhibit both soluble and membrane-bound forms of BAFF in cellular systems. Tumor Microenvironment CharacterizationRegardless of the model system chosen, anti-BAFF studies typically involve comprehensive characterization of the tumor microenvironment, including quantification of tumor-infiltrating lymphocytes and assessment of immune cell functionality. This characterization is crucial for understanding how BAFF inhibition modulates immune responses within the tumor context and affects overall therapeutic efficacy. The selection of appropriate models ultimately depends on whether the research aims to understand fundamental immune mechanisms (favoring syngeneic models) or to evaluate clinical translatability of specific therapeutic antibodies (potentially favoring humanized approaches). Tabalumab in Immune-Oncology: Context and MechanismTabalumab is a human monoclonal antibody that targets B-cell activating factor (BAFF), a cytokine crucial for B-cell survival and differentiation. Its primary application has been in autoimmune diseases, where blocking BAFF reduces B-cell proliferation and associated immune activities. In cancer, the rationale for targeting BAFF is less established compared to well-known immune checkpoint inhibitors like anti-CTLA-4, anti-PD-1, or anti-LAG-3, which are directly involved in T-cell regulation and tumor immune evasion. Synergy in Immune Checkpoint Inhibitor CombinationsImmune checkpoint inhibitors—such as anti-CTLA-4, anti-PD-1, and anti-LAG-3—are often combined to enhance antitumor immune responses by targeting non-redundant pathways. For example:
Combining these agents can lead to synergistic effects, as seen in clinical trials where dual checkpoint blockade (e.g., ipilimumab + nivolumab) improved outcomes in certain patient subsets. Importantly, the specific immune cell subsets activated (e.g., CD8+, CD4+, Tregs) and the mechanisms of action differ between regimens, even when targeting similar pathways. This underscores the need for careful preclinical and clinical evaluation of novel combinations. Potential Role of Tabalumab in Combination StudiesThere is no evidence in the provided literature that Tabalumab or its biosimilars are being used in combination with classic checkpoint inhibitors (anti-CTLA-4, anti-PD-1, anti-LAG-3) in immune-oncology models. The clinical and preclinical focus of Tabalumab has been on autoimmune diseases, not cancer immunotherapy. Hypothetical Rationale for Tabalumab in Cancer ImmunotherapyIf researchers were to explore Tabalumab in immune-oncology, the rationale might include:
Research Design Considerations
Current Limitations and Knowledge Gaps
Summary Table: Checkpoint Inhibitor vs. BAFF-Targeted Therapy
ConclusionThere is no current evidence that researchers are using Tabalumab or its biosimilars in combination with checkpoint inhibitors like anti-CTLA-4 or anti-LAG-3 to study synergistic effects in immune-oncology models. The rationale for such studies would be speculative, based on the potential for B-cell modulation to influence the TME and T-cell responses. Any such research would require careful preclinical validation to assess both efficacy and safety, given the distinct mechanisms of action between B-cell– and T-cell–targeted therapies. Use of Tabalumab Biosimilar in Bridging ADA ELISA for Immunogenicity TestingBridging ELISA is a widely used method for detecting anti-drug antibodies (ADAs) in patient samples, which is critical for monitoring the immunogenicity of therapeutic biologics, including biosimilars. In this assay, the drug (or a biosimilar) can be used both as the capture and detection reagent to specifically bind and identify ADAs present in patient serum. Role of the Tabalumab Biosimilar in the Assay
Why Use a Biosimilar?
Considerations in Immunogenicity Assessment
In summary, a Tabalumab biosimilar is used as both the capture and detection reagent in a bridging ADA ELISA to specifically monitor patient immune responses against the biosimilar. This setup ensures the assay is tailored to detect antibodies that may impact the safety and efficacy of the biosimilar therapy, supporting both clinical decision-making and pharmacovigilance. References & Citations1. Manetta, J. et al. (2014) J Inflamm Res. 7: 121–131 2. Clatworthy, MR. et al. (2013) Transplantation. 96(4): 413–420. 3. Lied, GA. and Berstad, A. (2011) Scand J Immunol. 73(1):1-7. 4. Büchler, JR. and Cano, MN. (1986) Jpn Heart J. 27(1):117-22. Technical ProtocolsCertificate of Analysis |
Formats Available
Prod No. | Description |
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LT1400 | |
LT1404 | |
LT1401 | |
LT1411 | |
LT1406 | |
LT1405 | |
LT1407 |
