Anti-Human CD20 (Obinutuzumab) [Clone GA101] — Biotin
Anti-Human CD20 (Obinutuzumab) [Clone GA101] — Biotin
Product No.: LT914
Product No.LT914 Clone GA101 Target CD20 Product Type Biosimilar Recombinant Human Monoclonal Antibody Alternate Names Obinutuzumab, CD20, MS4A1 Isotype Human IgG1κ Applications ELISA , FC |
Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells Immunogen Human lymphoblastoid cell line SB. 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 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 Applications and Recommended Usage? Quality Tested by Leinco FC,
ELISA 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 or reference controls in pharmacokinetic (PK) bridging ELISA assays to measure drug concentration in serum samples. These biosimilars enable the construction of standard curves and quality control samples critical for the quantitative assessment of both the biosimilar and reference antibody concentrations in biological matrices. Essential context and supporting details:
Key steps in using biosimilars as standards in PK bridging ELISA:
This approach underpins the regulatory and scientific rigor necessary for biosimilar PK comparability studies, ensuring both the test (biosimilar) and reference Obinutuzumab can be reliably measured and compared in clinical pharmacokinetic analyses. Standard flow cytometry protocols involving a conjugated Obinutuzumab biosimilar (e.g., PE- or APC-labeled) to validate CD20 expression levels or binding capacity typically follow these foundational steps:
Validation of CD20 Expression & Binding
Protocols for Binding Capacity
Key Insights
References to Specific Protocol Components
If you require a detailed protocol, including buffer compositions, antibody concentrations, or gating strategies, please specify your application (e.g., clinical validation, biosimilar characterization, or preclinical studies), as protocols can be adapted based on sample type and regulatory requirements. Biopharma companies typically perform a comprehensive suite of analytical assays to confirm the structural and functional similarity of a proposed biosimilar to the originator drug, focusing on critical quality attributes (CQAs) relevant to safety, efficacy, and clinical outcomes. Assays cover physicochemical, structural, and biological properties, and Leinco biosimilars are commonly employed as well-characterized reference standards or controls in these studies when available. Key Analytical Assays for Biosimilarity:
Role of Leinco Biosimilars in Analytical Similarity Studies:
When a biopharma company is developing a biosimilar, using Leinco’s characterized biosimilar reagents can strengthen assay confidence and reliability, enabling more accurate attribution of similarity or difference to the tested molecule rather than assay variability. These reagents are especially useful in orthogonal testing strategies, as recommended by regulatory guidelines. Additional Considerations:
In summary, biosimilar analytical characterization integrates multiple structural and functional assays, with products like Leinco biosimilars used as high-quality reference materials to calibrate and validate these studies, thus helping biopharma companies confidently demonstrate biosimilarity to regulators. 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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