Anti-Human HER-2 (Trastuzumab) – Fc Muted™

Anti-Human HER-2 (Trastuzumab) – Fc Muted™

Product No.: LT1505

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Product No.LT1505
Product Type
Biosimilar Recombinant Human Monoclonal Antibody
Alternate Names
ErbB-2, NEU, NGL, HER2, TKR1, CD340, MLN 19, HER-2/neu
Human IgG1

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Antibody Details

Product Details

Reactive Species
Expression Host
HEK-293 Cells
FC Effector Activity
Human epidermoid carcinoma cells (A431) over-expressing EGFR.
Product Concentration
≥ 5.0 mg/ml
Endotoxin Level
< 1.0 EU/mg as determined by the LAL method
≥95% monomer by analytical SEC
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.
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
2-8°C Wet Ice
Applications and Recommended Usage?
Quality Tested by Leinco
FC The suggested concentration for Trastuzumab biosimilar antibody for staining cells in flow cytometry is ≤ 0.25 μg per 106 cells in a volume of 100 μl. Titration of the reagent is recommended for optimal performance for each application.
Additional Applications Reported In Literature ?
Each investigator should determine their own optimal working dilution for specific applications. See directions on lot specific datasheets, as information may periodically change.


This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Trastuzumab. Clone 4D5-8 recognizes human erbB-2. This product is for research use only.
Trastuzumab is a monoclonal antibody targeting HER2, a 185 kDa transmembrane glycoprotein that contains an extracellular domain and intracellular tyrosine kinase activity. When it is functioning normally, the HER2 pathway supports cell growth and division. On the other hand, the over expression of HER2 propels cell growth beyond its typical range. This overexpression is associated with some cancers, namely breast and stomach, in which the HER2 protein can be expressed up to 100 times more than in typical cells. Trastuzumab induces an immune-mediated response that triggers the internalization and downregulation of HER2 making it an excellent target for immunotherapy. Several clinical studies are under way which show that anti-HER-2/neu antibodies inhibit the growth and proliferation of these tumor cells In vitro as well as In vivo.
Antigen Distribution
Ubiquitous expression with highest expression levels found in the kidney, skin, esophagus, and small intestine.

Antigen Details

NCBI Gene Bank ID

References & Citations

1. Fendly, B. et al. (1990) Cancer Research 50: 1550-1558.
2. McBride, H. et al. (2019) Pharm Res. 36(12): 177.
3. Zielinski, C. et al. (1997) Int. J. Cancer 73: 875–879
4. Valone, FH. et al. (1995) J. Clin. Oncology 13 (9): 2281-92.
5. Hynes, NE. et al. (1993) Br J Cancer. 68(6): 1140–1145.
Indirect Elisa Protocol
Flow Cytometry

Certificate of Analysis

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