Anti-Human CD257 (BAFF) (Tabalumab) – Fc Muted™ Biotin
Anti-Human CD257 (BAFF) (Tabalumab) – Fc Muted™ Biotin
Product No.: LT1406
Product No.LT1406 Clone Tabalumab Target BAFF Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Tabalumab, CD257, BAFF, TNFSF13b, BLYS Isotype Human IgG1κ |
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 0.5 mg/ml Formulation This Biotinylated antibody 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. State of Matter Liquid Storage and Handling This biotinylated antibody is stable when stored at 2-8°C. Do not freeze. Regulatory Status Research Use Only (RUO). Non-Therapeutic. Country of Origin USA Shipping 2-8°C Wet Ice RRIDAB_2893907 Additional Reported Applications For Relevant Conjugates ? N IP WB 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. Use of Research-Grade Tabalumab Biosimilars as Calibration Standards in PK Bridging ELISABiosimilars are laboratory-made versions of existing biologic drugs designed to be highly similar, but not necessarily identical, to the reference product. In the context of pharmacokinetic (PK) studies—especially those supporting biosimilar development—calibration standards and reference controls play a crucial role in ensuring the accuracy, precision, and reliability of drug concentration measurements in biological matrices like serum. Role of Biosimilars as Calibration Standards
Bridging ELISA for Drug Measurement
Step-by-Step Application in PK Studies
Scientific and Regulatory Considerations
Summary Table
ConclusionResearch-grade tabalumab biosimilars are used as calibration standards and reference controls in PK bridging ELISAs by serving as the primary material for constructing the assay's standard curve and quality controls. This ensures that the pharmacokinetic profiles of both the biosimilar and reference product can be compared directly and accurately within the same assay system, supporting robust bioequivalence assessments required for regulatory approval. This approach minimizes variability, enhances data reliability, and is aligned with current industry and regulatory best practices for biosimilar development. Standard flow cytometry protocols using a conjugated Tabalumab biosimilar (e.g., PE or APC-labeled) for validating BAFF expression levels or binding capacity typically involve direct staining of cells expressing BAFF and analysis of fluorescence intensity to quantify binding or expression. Essential protocol steps and context:
Key considerations:
Typical applications for these protocols include:
If using a labeled Tabalumab biosimilar directly (PE/APC conjugate), the protocol is streamlined by eliminating secondary detection steps, maintaining sensitivity and specificity in flow cytometric assays. Biopharma companies perform a comprehensive battery of analytical assays to establish the structural and functional similarity of biosimilars to their reference products. This analytical similarity assessment is the foundation of biosimilar development and regulatory approval. Structural Characterization AssaysThe structural assessment encompasses multiple levels of protein analysis. Primary structure evaluation includes amino acid sequencing and peptide mapping to confirm the correct protein sequence. Secondary and higher-order structure analysis utilizes techniques such as circular dichroism spectroscopy and nuclear magnetic resonance to assess protein folding patterns. Mass spectrometry and chromatographic techniques are extensively deployed to evaluate post-translational modifications, including glycosylation patterns, which can significantly impact protein function. Physicochemical characterization involves determining molecular weight, charge variants, and thermal stability profiles. These properties are ranked by their potential risk of impact on the product's activity, pharmacokinetics, pharmacodynamics, safety, efficacy, or immunogenicity. Functional Assessment MethodsFunctional assays serve as the crucial bridge between structural data and clinical expectations, answering whether observed structural differences translate into functional significance. The functional characterization program typically includes two main categories of assays. Binding assays evaluate the biosimilar's ability to interact with its intended targets, including antigen binding for monoclonal antibodies and receptor binding studies. For antibody-based biosimilars, Fc receptor binding assays assess interaction with immune receptors like FcγRIIIa, which is critical for antibody-dependent cellular cytotoxicity. Cell-based biological assays measure the actual biological activity of the molecule in relevant cellular systems. These include potency assays that assess the functional activity of the biosimilar compared to the reference product, enzyme kinetics studies, and bioassays that measure specific biological responses. Purity and Impurity ProfilingThe analytical assessment includes rigorous comparison of purity and impurity profiles, which serves as a sensitive fingerprint of the entire manufacturing process. This analysis focuses on product-related variants such as aggregates, fragments, precursors, and other modified forms that may arise during manufacturing or storage. Process-related impurities are also evaluated, including host cell proteins, DNA, and residual solvents that could impact safety or efficacy. The impurity profile comparison provides indirect evidence that the biosimilar developer has successfully replicated critical manufacturing process controls. Analytical Strategy and ImplementationManufacturers conduct head-to-head comparisons of the proposed biosimilar's properties against the reference product, with results required to fall within appropriate limits, ranges, or distributions. The approach often employs multiple complementary or orthogonal methods to better characterize product properties and more sensitively assess potential differences. The analytical studies utilize highly sensitive analytical methods that allow measurement of molecular properties across multiple lots of both the biosimilar and reference product. This extensive characterization of the reference product establishes the standards against which the proposed biosimilar is evaluated. Critical Quality Attributes FocusThe analytical similarity assessment involves identification of critical quality attributes (CQAs) that are relevant to clinical outcomes. The objective is to demonstrate a highly similar profile with respect to variations in these CQAs, with variations required to lie within the range established by the innovator product. Regarding the specific question about Leinco biosimilars, the search results do not contain any information about Leinco or how their biosimilars are specifically used in analytical similarity studies. The information available focuses on general analytical approaches and regulatory requirements for biosimilar assessment rather than specific company products or applications. 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. |
Formats Available
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LT1400 | |
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LT1401 | |
LT1411 | |
LT1406 | |
LT1405 | |
LT1407 |
