Anti-Human CD49D (Integrin alpha 4) (Natalizumab) – Dylight® 488
Anti-Human CD49D (Integrin alpha 4) (Natalizumab) – Dylight® 488
Product No.: LT1111
Product No.LT1111 Clone Hu114 Target CD49D Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names CD49D; alpha 4 subunit of VLA-4 receptor; ITGA4; Integrin alpha-IV Isotype Human IgG4κ Applications FC |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Active Immunogen RAMOS cell line injected into mice. Product Concentration 0.2 mg/ml Formulation This DyLight® 488 conjugate 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. Storage and Handling This DyLight® 488 conjugate is stable when stored at 2-8°C. Do not freeze. Regulatory Status Research Use Only (RUO). Non-Therapeutic. Country of Origin USA Shipping Next Day 2-8°C Excitation Laser Blue Laser (493 nm) RRIDAB_2893892 Applications and Recommended Usage? Quality Tested by Leinco FC The suggested concentration for Natalizumab biosimilar antibody for staining cells in flow cytometry is ≤ 1.0 μg per 106 cells in a volume of 100 μl. Titration of the reagent is recommended for optimal performance for each application. Additional Reported Applications For Relevant Conjugates ? B 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 Natalizumab. Natalizumab binds to the alpha 4 subunit of α4β1 and α4β7 integrins. This product is for research use only. Background Natalizumab is characterized as a disease-modifying therapy for multiple sclerosis (a disease of the central nervous system (CNS)), and inflammatory bowel disease. It works by inhibiting the migration of leukocytes to inflammation sites. The VCAM-1 and α4β1-integrin interaction is necessary for leukocyte adhesion, firm attachment, and transmigration across the blood-brain barrier into the CNS. Natalizumab, a recombinant, humanized antibody, binds to α4β1 -integrin and blocks its interaction with VCAM-1. Hence, leukocyte migration into brain tissue is inhibited, thereby reducing inflammation and preventing the formation of multiple sclerosis lesions.1 Inflammation in the gut pertaining to inflammatory bowel disease can be controlled in a similar fashion. Blocking α4β7-integrin with a humanized, monoclonal antibody, specific to the α4β7 heterodimer inhibits the migration of leukocytes into the inflamed intestinal tissue, thus, reducing inflammation in the gut.2 This cost-effective, research-grade Anti-Human CD49D (Natalizumab) utilizes the same variable regions from the therapeutic antibody Natalizumab making it ideal for research projects. Antigen Distribution CD49D is a subunit of the integrin VLA-4, which is expressed on the cell surfaces of stem cells, progenitor cells, T and B cells, monocytes, natural killer cells, eosinophils, and neutrophils. PubMed NCBI Gene Bank ID UniProt.org Research Area Biosimilars . Cell Adhesion . Cell Biology . Immunology . Innate Immunity 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 natalizumab biosimilars play a crucial role as calibration standards and reference controls in pharmacokinetic (PK) bridging ELISA assays designed to measure drug concentrations in serum samples. The implementation follows a scientifically rigorous approach that ensures accurate quantification of both biosimilar and reference products. Single PK Assay StrategyThe most optimal approach for biosimilar natalizumab PK studies is to develop a single PK assay using a single analytical standard for quantitative measurement of both the biosimilar and reference products. This strategy offers significant advantages by decreasing inherent variability that would be associated with running multiple methods and eliminating the need for crossover analysis when conducting blinded clinical studies. Method Development and Validation ProcessThe development process begins with a comprehensive method qualification study that generates precision and accuracy data sets of both the biosimilar and reference natalizumab products. Statistical analysis is then applied to determine if the test products are bioanalytically equivalent within the method. If the test products demonstrate bioanalytical comparability, the data supports conducting validation of the method using a single analytical standard as the assay calibrator to quantify sets of Quality Control (QC) samples prepared with both the biosimilar and reference products. With bioanalytical comparability established across test products, the biosimilar is typically selected as the analytical standard for the single method. ELISA Technical ImplementationThe natalizumab PK ELISA follows a sandwich ELISA format where natalizumab is captured by anti-idiotype antibody and subsequently detected by anti-human antibody. For research-grade assays, the method utilizes solid phase enzyme-linked immunosorbent assay based on the sandwich principle, where standards and samples are incubated in microtiter plates coated with the reactant for natalizumab. The technical process involves:
Assay Performance CharacteristicsResearch-grade natalizumab ELISA assays typically demonstrate:
Quality Control and StandardizationThe use of biosimilar natalizumab as calibration standards requires establishing bioanalytical comparability between the test products within the method through rigorous statistical analysis. This approach provides a solid data package to demonstrate the method is suitable for its intended use while maintaining the precision, accuracy, and robustness required for quantitative measurement of both biosimilar and reference products sourced from different regions. The calibration standards enable direct quantification of natalizumab concentrations in patient serum samples, with results determined using the standard curve generated from the biosimilar reference material. This standardized approach is essential for supporting biosimilar product development and regulatory submissions requiring PK bioequivalence assessments. Standard flow cytometry protocols for validating CD49D (α4-integrin) expression or binding capacity using a conjugated Natalizumab biosimilar (e.g., PE or APC-labeled) involve quantitative assessment of both surface CD49d levels and receptor saturation on lymphocyte subsets (CD4+, CD8+ T cells, CD19+ B cells). These protocols provide a means to monitor biological drug binding, receptor occupancy, and are used clinically to assess therapy efficacy and detect the development of neutralizing antibodies. Essential protocol elements
Key considerations
Example usage in literature
Alternative or complementary protocols
In summary: The standard protocol employs either directly conjugated Natalizumab biosimilar (PE or APC-labeled) or secondary fluorochrome-coupled antibodies to quantify CD49d expression, receptor occupancy, and binding capacity via multiparametric flow cytometry in patient samples. This method is effective for therapeutic monitoring, quantifying receptor saturation, and detecting anti-drug antibodies. Biopharma companies conduct a comprehensive suite of analytical assays to confirm that a proposed biosimilar is highly similar in both structure and function to its originator (reference) drug. These studies are foundational for biosimilar approval, and the assays span multiple, orthogonal methods to collectively demonstrate similarity. Key Analytical Assays Performed:
Role of Leinco Biosimilars in Analytical Studies:
In summary, biosimilar analytical similarity studies employ a battery of structural and functional assays—spanning sequence, post-translational modifications, higher-order structure, purity, and biological function—to ensure the proposed product matches the originator. Biosimilars from companies like Leinco play a supporting role as standardized reagents in these highly regulated and rigorous assays. References & Citations1. Hutchinson, M. (2007) Ther Clin Risk Manag. 3(2):259-68. 2. Vandervoort, M. et al. (2005) N Engl J Med 352:2499-507. Technical ProtocolsCertificate of Analysis |
Formats Available
Prod No. | Description |
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LT1100 | |
LT1103 | |
LT1104 | |
LT1111 | |
LT1105 |
