Anti-Human PD-L1 (CD274) (Avelumab) [Clone MSB0010718C] — Fc Muted™
Anti-Human PD-L1 (CD274) (Avelumab) [Clone MSB0010718C] — Fc Muted™
Product No.: P705
Product No.P705 Clone MSB0010718C Target PD-L1 Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Avelumab, PD-L1 Isotype Human IgG1 L1 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 PD-L1 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 Additional Applications Reported In Literature ? ELISA, WB, IP, FA, FC 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 Avelumab. This product is for research use only.Avelumab blocks PD-L1 ligand from interacting with its receptors PD-1 and B7.1. Background Programmed cell death 1 ligand 1 (PD-L1; CD274; B7-H1) is a type I transmembrane glycoprotein widely expressed in many types of tissues that acts as a ligand for the immune inhibitory receptor programmed cell death 1 (PD-1; CD279)1, 2, 3 and B7.14. The PD-1 pathway is responsible for T cell activation, proliferation, and cytotoxic secretion, with PD-1/PD-L1 interaction triggering inhibitory signals that dampen T cell function. PD-L1 also plays a critical role in the differentiation of inducible regulatory T cells5.
In normal tissues, PD-L1/PD-1 ligation is crucial to maintaining homeostasis of the immune system and preventing autoimmunity during infection and inflammation5. In the tumor microenvironment, their interaction provides an immune escape mechanism for tumor cells by turning off cytotoxic T cells. As such, blocking the PD-L1/PD-1 interaction is a target of many anti-cancer immunotherapies. Avelumab is a human IgG1 lambda monoclonal antibody that blocks the interaction between PD-L1 and its receptors PD-1 and B7.1, thereby enabling T cell activation and restoration of the adaptive immune response4. Avelumab can lyse a range of human tumor cells in the presence of peripheral blood mononuclear cells or natural killer cells6, 7. Avelumab engages both adaptive and innate immune functions and mediates antibody-dependent cell-mediated cytotoxicity by retaining a native Fc region6, 7. Avelumab binds to a functional epitope comprising residues Y56, D61, E58, E60, Q66, R113 and M115 as well as a conformational epitope comprising residues 54-66 and 12-122 of human PD-L18. Antigen Distribution PD-L1 is commonly expressed on the surface of antigen presenting cells (macrophages, activated B cells, dendritic cells), some epithelial cells under inflammatory conditions, some activated T cells, and several types of tumors as well as tumor infiltrating immune cells. PD-L1 can also exist in a soluble form (sPD-L1) in myeloid-derived cells (monocytes, macrophages, and dendritic cells) and several human cancer lines. Ligand/Receptor PD1 (CD279) NCBI Gene Bank ID UniProt.org Research Area Biosimilars . Immuno-Oncology . Immunology . 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 Avelumab biosimilars serve as critical calibration standards in pharmacokinetic (PK) bridging ELISAs through a comprehensive analytical framework designed to ensure accurate and reliable measurement of drug concentrations in serum samples. Single Assay Methodology with Biosimilar StandardsThe optimal approach for PK assays involves developing a single analytical method that uses one standardized calibration reference for quantifying both biosimilar and reference products. In practice, this means the biosimilar Avelumab is selected as the analytical standard for the unified method, creating a streamlined approach that eliminates variability associated with running multiple methods and removes the need for crossover analysis during blinded clinical studies. Calibration Standard Preparation and Concentration RangeResearch-grade Avelumab biosimilars are prepared as calibration standards in human serum across a wide concentration range. During method validation, nine independent sets of biosimilar standards are typically analyzed with nominal concentrations of 50, 100, 200, 400, 800, 1600, 3200, 6400, and 12800 ng/mL. This broad range ensures accurate quantification across the expected pharmacokinetic profile of the drug in patient samples. ELISA Assay Configuration and Detection PrinciplesThe bridging ELISA employs a sandwich assay principle where standards and serum samples are incubated in microtiter plates coated with specific reactants for Avelumab. The biosimilar standards create a calibration curve through the following process:
Bioanalytical Comparability AssessmentBefore implementing the single standard approach, a comprehensive method qualification study must demonstrate bioanalytical equivalence between the biosimilar and reference products. This involves: Statistical Validation: Precision and accuracy datasets are generated for both biosimilar and reference products, with statistical analysis determining if test products are bioanalytically equivalent within the method. Equivalence Criteria: The 90% confidence interval is compared to pre-defined equivalence intervals [0.8, 1.25], and bioanalytical equivalence is concluded by combining the totality of evidence. Quality Control ImplementationOnce bioanalytical comparability is established, the method validation proceeds using the biosimilar as the single analytical standard to quantify Quality Control (QC) samples prepared with both biosimilar and reference products. Validation QC samples are typically prepared at concentrations of 50, 150, 1250, 9600, and 12800 ng/mL and quantified against the biosimilar standard curve. Analytical Performance SpecificationsResearch-grade biosimilar standards enable robust analytical performance with specific technical parameters:
This standardized approach ensures that concentration data serves as a reliable foundation for PK bioequivalence assessment and dose-response profile characterization, meeting regulatory requirements for biosimilar drug development studies. The primary in vivo models for studying anti-PD-L1 antibody-mediated tumor growth inhibition and characterization of tumor-infiltrating lymphocytes (TILs) are:
Here are details for each category, with representative models and key methods: Syngeneic Models These are the most widely used platforms for anti-PD-L1 studies due to their fully functional mouse immune systems.
Assessment & Readouts:
Humanized Mouse Models These models enable study of human-specific antibodies and tumor-immune interactions.
Assessment & Readouts:
Summary Comparison Table
In summary:
Researchers investigate the synergistic effects of avelumab biosimilars combined with other checkpoint inhibitors (such as anti-CTLA-4 or anti-LAG-3 biosimilars) by using complex immune-oncology models—including in vitro co-culture systems, humanized mouse models, and clinical trials—to analyze enhanced immune activation and tumor response. Key context and supporting details:
In summary, avelumab biosimilars are combined with other checkpoint inhibitors in advanced immune-oncology models to explore whether dual or multi-pathway blockade results in more robust immune responses and tumor suppression, with researchers tracking both mechanistic (immune activation) and clinical (survival, tumor regression) endpoints to define synergy. A Avelumab biosimilar can be directly used as a capture and/or detection reagent in a bridging ADA ELISA to monitor a patient's immune response by detecting anti-drug antibodies (ADAs) generated against Avelumab therapy. In this assay format, the biosimilar serves as a structural and functional proxy for the original drug to bind patient-derived ADAs, making it suitable for immunogenicity testing as long as it mimics the reference antibody's epitopes and post-translational modifications. Key Steps in the Bridging ADA ELISA Using a Avelumab Biosimilar:
Why Use a Biosimilar as Reagent?
Critical Assay Considerations:
Practical Example:Suppose you use a commercial Avelumab biosimilar (e.g., from Bio X Cell) in both biotinylated and HRP-conjugated forms. Both forms would be manufactured to preserve native structure so that patient-derived ADAs generated against Avelumab therapy would efficiently form the antibody "bridge" required for sensitive and specific detection. In summary, a Avelumab biosimilar is suitable for use as both capture and detection reagent in bridging ADA ELISA as long as it faithfully mimics the therapeutic's structure, enabling an effective assessment of patient immunogenicity toward Avelumab therapy. References & Citations1. Freeman GJ, Long AJ, Iwai Y, et al. J Exp Med. 2000192(7):1027-1034. 2000.
2. Tsai KK, Zarzoso I, Daud AI. Hum Vaccin Immunother. 10(11):3111-3116. 2014. 3. Han Y, Liu D, Li L. Am J Cancer Res. 10(3):727-742. 2020. 4. Kim ES. Drugs. 77(8):929-937. 2017. 5. Dermani FK, Samadi P, Rahmani G, et al. J Cell Physiol. 234(2):1313-1325. 2019. 6. Boyerinas B, Jochems C, Fantini M, et al. Cancer Immunol Res. 3(10):1148-1157. 2015. 7. Collins JM, Gulley JL. Hum Vaccin Immunother. 15(4):891-908. 2019. 8. https://patents.google.com/patent/WO2013079174A1/en Technical ProtocolsCertificate of Analysis |
Formats Available
