Anti-Human CD20 (Obinutuzumab) [Clone GA101] — Fc Muted™
Anti-Human CD20 (Obinutuzumab) [Clone GA101] — Fc Muted™
Product No.: LT912
Product No.LT912 Clone GA101 Target CD20 Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Obinutuzumab, CD20, MS4A1, 949142-50-1 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 lymphoblastoid cell line SB. 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_2894029 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 Obinutuzumab. This product is for research use only. Obinutuzumab (GA101) activity is directed against human CD20. Background CD20 is a nonglycosylated 33-37 kDa phosphoprotein 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. Anti-CD20 mAbs bind to the 44 amino acid extracellular portion.
Obinutuzumab (GA101) is a new generation, type II, anti-CD20 antibody2. Obinutuzumab was humanized by grafting the complementarity-determining sequences of murine IgG1-κ antibody B-Ly1 onto human VH and VL acceptor frameworks3. The Fc segment was glycoengineered to attach bisected, complex, nonfucosylated oligosaccharides to asparagine 297, leading to increased affinity to FcgRIII. Obinutuzumab causes homotypic adhesion4,5,6, induces direct cell death via largely caspase-independent mechanisms4,6,7,8,9, does not localize into lipid rafts4,10,11, displays half-maximal CD20 binding at saturating conditions7, and displays minimal complement dependent cytotoxicity7. Compared to rituximab, obinutuzumab recognizes a distinct but overlapping CD20 epitope, in a different orientation that results in increased pro-apoptotic potential12,13,14. A modified elbow-hinge residue, characterized by a leucine to valine mutation at Kabat position 11, is key to superior phosphatidylserine exposure and cell death relative to rituximab3. Antigen Distribution CD20 is a general B cell marker expressed by the majority of normal B cells in all stages of their development as well as by most B cell malignancies. Ligand/Receptor Src family tyrosine kinases, MHC class I, II, CD53, CD81, CD82 PubMed NCBI Gene Bank ID UniProt.org Research Area Biosimilars . Cancer . 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 Obinutuzumab biosimilars are commonly used as calibration standards and reference controls in pharmacokinetic (PK) bridging ELISAs to accurately measure drug concentrations in serum samples in biosimilar development. In a PK bridging ELISA, the analytical procedure typically involves:
Key rationale and usage:
Summary table – Uses in PK bridging ELISA:
This approach ensures robust, comparable, and regulatory-compliant measurement of Obinutuzumab in clinical PK studies with biosimilar candidates. The primary preclinical models used to study in vivo administration of research-grade anti-CD20 antibodies for tumor growth inhibition and analysis of tumor-infiltrating lymphocytes (TILs) are syngeneic mouse tumor models engineered to express human CD20 and models utilizing murine-specific anti-CD20 antibodies in fully immunocompetent mice. Key model types:
References:Describes use of A20-huCD20 in syngeneic models for tumor inhibition and TIL assessment.Uses EL4-huCD20 cells in a syngeneic mouse model to study anti-CD20 mechanisms, tumor cell killing, and effector functions involving TILs.Describes anti-mouse CD20 in syngeneic solid tumor models for studying B-cell depletion effects on TILs.Reviews immune profiling across multiple syngeneic models, including effects of immunotherapies on TILs. Researchers use Obinutuzumab biosimilars in combination with other checkpoint inhibitors (such as anti-CTLA-4 or anti-LAG-3 biosimilars) to evaluate synergistic antitumor effects within complex immune-oncology models, primarily through both preclinical (in vitro and animal) studies and early-phase clinical trials. Key approaches in synergy studies:
Study design considerations:
Limitations and ongoing research:
In sum, researchers leverage obinutuzumab biosimilars together with checkpoint inhibitors in controlled models to investigate multi-faceted immune activation, aiming to potentiate tumor clearance while monitoring safety—laying the groundwork for rational clinical combination strategies in immune-oncology. In the context of immunogenicity testing, a biosimilar of obinutuzumab, like other therapeutic antibodies, can be used as part of a bridging ELISA to monitor a patient's immune response against therapeutic drugs. Here's how it might be applied: Bridging ELISA OverviewA bridging ELISA is a diagnostic tool used to detect anti-drug antibodies (ADAs), which are antibodies that a patient's immune system produces in response to therapeutic drugs, including monoclonal antibodies like obinutuzumab. Use of Obinutuzumab Biosimilar in Bridging ELISA
ConclusionUsing a biosimilar of obinutuzumab in a bridging ELISA provides a precise method to monitor patient immune responses by detecting ADAs, which is crucial for assessing the efficacy and safety of therapeutic antibodies. However, specific technical details about using obinutuzumab or its biosimilar in this context would typically be established based on the specific requirements and protocols of the implementing laboratory. 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. Mössner E, Brünker P, Moser S, et al. Blood. 115(22):4393-4402. 2010. 4. Chan HT, Hughes D, French RR, et al. Cancer Res. 63(17):5480-5489. 2003. 5. Ivanov A, Beers SA, Walshe CA, et al. J Clin Invest. 119(8):2143-2159. 2009. 6. Alduaij W, Ivanov A, Honeychurch J, et al. Blood. 117(17):4519-4529. 2011. 7. Herter S, Herting F, Mundigl O, et al. Mol Cancer Ther. 12(10):2031-2042. 2013. 8. Honeychurch J, Alduaij W, Azizyan M, et al. Blood. 119(15):3523-3533. 2012. 9. Golay J, Zaffaroni L, Vaccari T, et al. Blood. 95(12):3900-3908. 2000. 10. Cragg MS, Morgan SM, Chan HT, et al. Blood. 101(3):1045-1052. 2003. 11. Cragg MS, Glennie MJ. Blood. 103(7):2738-2743. 2004. 12. Niederfellner G, Lammens A, Mundigl O, et al. Blood. 118(2):358-367. 2011. 13. Klein C, Lammens A, Schäfer W, et al. MAbs. 5(1):22-33. 2013. 14. Könitzer JD, Sieron A, Wacker A, Enenkel B. PLoS One. 10(12):e0145633. 2015. 15. Terszowski G, Klein C, Stern M. J Immunol. 192(12):5618-5624. 2014. 16. Bologna L, Gotti E, Manganini M, et al. J Immunol. 186(6):3762-3769. 2011. 17. Ysebaert L, Laprévotte E, Klein C, Quillet-Mary A. Blood Cancer J. 5(11):e367. 2015. 18. Cartron G, Hourcade-Potelleret F, Morschhauser F, et al. Haematologica. 101(2):226-234. 2016. Technical ProtocolsCertificate of Analysis |
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