Anti-Human CD3 (Teplizumab) – Fc Muted™

Anti-Human CD3 (Teplizumab) – Fc Muted™

Product No.: LT2105

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Product No.LT2105
Clone
PRV-031
Target
CD3
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
Teplizumab, CD3ε
Isotype
Human IgG1κ
Applications
ELISA
,
FA
,
FC
,
IP
,
WB

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Select Product Size
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Antibody Details

Product Details

Reactive Species
Human
Expression Host
HEK-293 Cells
FC Effector Activity
Muted
Immunogen
Human CD3
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 (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.

Description

Specificity
This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Teplizumab. This product is for research use only. Teplizumab activity is directed against CD3 expressed on mature T cells.
Background
Type I diabetes is a chronic autoimmune disease that destroys insulin-producing beta-cells in the islets of Langerhans, leading to a dependence on exogenous insulin for survival1. Teplizumab (TZIELD) is a humanized, anti-CD3ε IgG1κ monoclonal therapeutic that delays the onset of Stage 3 Type 1 diabetes1, 2. CD3ε plays an essential role in T cell development and is part of the T cell-receptor CD3-complex, which acts as an external signal transducer3. Defects in CD3ε cause immunodeficiency and have been linked to susceptibility to type I diabetes in women.

Teplizumab is an Fc receptor-nonbinding anti-CD3 antibody4 whose Fc region is mutated (L234A; L235A) to reduce effector functions2. When Teplizumab is administered by intravenous infusion once daily for 14 consecutive days, it reduces the loss of beta-cell function1. Teplizumab treatment modifies CD8+ T lymphocytes, which are thought to kill beta-cells, to display a partially exhausted phenotype associated with delayed disease progression1, 5. Teplizumab delays the median onset of Stage 3 Type 1 diabetes by 2 years compared to placebo1, 2. Additionally, the effects of treatment persist over time. The median years to diabetes diagnosis after Teplizumab treatment is ~ 5 years compared to ~ 2 years in the placebo-treated group6.

In November 2022, the United States Food and Drug Administration approved Teplizumab injection to delay the onset of Stage 3 Type 1 diabetes in adults and pediatric patients aged 8 years and older who have Stage 2 Type 1 diabetes7.
Antigen Distribution
CD3 is found on the surface of mature T cells.

Antigen Details

Ligand/Receptor
Peptide antigen bound to MHC
NCBI Gene Bank ID
UniProt.org
Research Area
Biosimilars
.
Immunology

References & Citations

1. Herold KC, Bundy BN, Long SA, et al. N Engl J Med. 381(7):603-613. 2019.
2. Kaplon H, Crescioli S, Chenoweth A, et al. MAbs. 15(1):2153410. 2023.
3. https://www.ncbi.nlm.nih.gov/gene/916
4. Herold KC, Hagopian W, Auger JA, et al. N Engl J Med. 346(22):1692-1698. 2002.
5. Long SA, Thorpe J, DeBerg HA, et al. Sci Immunol. 1(5):eaai7793. 2016.
6. Sims EK, Bundy BN, Stier K, et al. Sci Transl Med. 13(583):eabc8980. 2021.
7. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes
8. Herold KC, Bluestone JA, Montag AG, et al. Diabetes. 41(3):385-391. 1992.
9. Herold KC, Gitelman SE, Ehlers MR, et al. Diabetes. 62(11):3766-3774. 2013.
Indirect Elisa Protocol
FA
Flow Cytometry
Immunoprecipitation Protocol
General Western Blot Protocol

Certificate of Analysis

Formats Available

Disclaimer AlertProducts are for research use only. Not for use in diagnostic or therapeutic procedures.