Anti-Human CD20 (Obinutuzumab) [Clone GA101] — FITC
Anti-Human CD20 (Obinutuzumab) [Clone GA101] — FITC
Product No.: LT913
Product No.LT913 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 0.2 mg/ml Formulation This Fluorescein (FITC) 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. 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 Excitation Laser Blue Laser (490 nm) 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 primarily used as calibration standards or reference controls in pharmacokinetic (PK) bridging ELISA by serving as the quantifiable standard against which serum drug concentrations are measured. Calibration standards are prepared using the biosimilar and are serially diluted in serum matrix to produce a standard curve, which allows for the interpolation of unknown sample concentrations. Context and Key Steps:
Additional Relevant Details:
Summary Table: Role of Obinutuzumab Biosimilar in PK Bridging ELISA
This workflow is essential for accurate, precise, and comparable measurement of obinutuzumab concentrations in serum during PK bridging studies and biosimilar development. Standard flow cytometry protocols for using a conjugated obinutuzumab biosimilar (such as PE or APC-labeled) to validate CD20 expression or binding typically involve incubation of the antibody with target cells, followed by signal detection and antibody specificity controls. Overview of Protocol Components
Key Control and Validation Steps
Data Interpretation
Reference Protocol Example (Synthesized from ):
Best Practices
These steps and controls are consistent with best practice in flow cytometric assessment of antibody binding and target antigen expression. They have been successfully implemented for evaluating CD20 expression and antibody binding specificity with obinutuzumab, both for basic research and antibody development/characterization purposes. Biopharma companies typically perform a detailed array of analytical structural and functional assays to confirm that a proposed biosimilar matches the originator drug in both molecular features and biologic function. These studies focus on comparing critical quality attributes (CQAs) using precise and complementary techniques. Essential context and supporting details: Core Analytical Assays Typically Performed
Regulatory Guidance
Leinco Biosimilar Use in Analytical StudiesNo specific details regarding the use of a Leinco biosimilar in such analytical similarity studies are indicated in the provided search results. Leinco Technologies is known for supplying recombinant antibodies and biosimilars used as standard references, controls, or assay reagents in analytical testing; in practice, a Leinco biosimilar would be used alongside the reference product for head-to-head comparisons in the described assays—serving either as a sample to verify test performance or as a surrogate standard in specific functional or structural assessment platforms. This is an inference based on general industry practices, given Leinco’s catalog and typical roles as an analytical reagent supplier. Summary of Key Points
If further clarity on Leinco biosimilars' specific analytical application is needed, more targeted documentation or direct reference from Leinco would be required. 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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