Anti-Human CD3 x CD20 (Mosunetuzumab)
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Antibody DetailsProduct DetailsReactive Species Human Host Species Human Expression Host HEK-293 Cells FC Effector Activity Active Immunogen Humanized antibody bispecifically binds to human CD20 and CD3ε to engage T cells 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 biosimilar 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 -80°C. Avoid Repeated Freeze Thaw Cycles. Regulatory Status Research Use Only Country of Origin USA Shipping 2 – 8° C Wet Ice Additional Applications Reported In Literature ? ELISA, 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 Mosunetuzumab. Mosunetuzumab simultaneously binds human CD3 and CD20. Background Mosunetuzumab is a CD20xCD3 Bispecific T cell Engager (BiTE) antibody developed as a
cancer immunotherapeutic drug1 using knobs-in-holes engineering2. Simultaneous targeting of
CD20 B cell on lymphomas and CD3 on T cells, leads to T cell activation, the release of perforin
and granzymes, and ultimately the depletion of malignant B cells through lysis and cell death1.
Mosunetuzumab benefits from CH mutations that limit its effector functions3, having a
modified, aglycosylated2 Fc with no Fcγ receptor or complement binding and only one binding
site to CD203. Mosunetuzumab is subject to splicing-mediated mechanisms of epitope loss4. CD20 is a nonglycosylated 33-37 kDa phosphoprotein member of the MS4A family5,6 that encodes four variants (V1-4)4, with V1 and V3 being the most abundant. Mosunetuzumab is only effective against V3-expressing B cells, and this likely plays a role in resistance to Mosunetuzumab in some patients4. Mosunetuzumab is approved to treat follicular lymphoma, the second most common subtype of non-Hodgkin’s lymphoma1. The biological role of CD20 remains poorly understood; however, it is thought to be involved in calcium ion influx5,6. 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. CD3 is an invariant antigen of the T cell TCR (T cell receptor), which is responsible for recognizing peptides bound to major histocompatibility complex molecules. Antigen Distribution CD20 is widely expressed on normal B cells during all stages of
development, as well as by most B cell malignancies. CD3 is a T cell surface glycoprotein. NCBI Gene Bank ID Research Area Biosimilars . Cancer . Immunology References & Citations1 Kang C. Drugs. 82(11):1229-1234. 2022. 2 Kaplon H, Crescioli S, Chenoweth A, et al. MAbs. 15(1):2153410. 2023. 3 Tavarozzi R, Manzato E. Antibodies (Basel). 11(1):16. 2022 Feb 21;11(1):16. 4 Ang Z, Paruzzo L, Hayer KE, et al. Blood. Sep 8:blood.2023020400. 2023. 5 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. 6 Freeman CL, Sehn LH. Br J Haematol. 182(1):29-45. 2018. 7 Hernandez G, Huw LY, Belousov A, et al. Blood. 134(Suppl 1):1585. 2019. 8 Budde LE, Assouline S, Sehn LH, et al. J Clin Oncol. 40(5):481-491. 2022. 9 Bartlett NL, Assouline S, Giri P, et al. Blood Adv. 7(17):4926-4935. 2023. Technical ProtocolsCertificate of Analysis |
Formats Available
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Prod No. | Description |
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C950 | |
C955 |
