Trastuzumab biosimilar, Human HER2 monoclonal antibody

Recombinant Humanized IgG1 Monoclonal Antibody.
Isotype: Human IgG1 kappa.
Source: The monoclonal antibody trastuzumab biosimilar was produced in the trastuzumab biosimilar CHO stable cell line, which is available for licensing to manufacture the trastuzumab biosimilar protein.
Specificity/Sensitivity: The monoclonal antibody trastuzumab biosimilar specifically binds to the human HER2 / ErbB-2 / c-neu.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by trastuzumab.
Form of Antibody: 0.2 uM filtered solution, pH 6.0, no stabilizers or preservatives.
Endotoxin: < 1 EU per 1 mg of the protein by the LAL method.
Purity: >95% by SDS-PAGE under reducing conditions and HPLC.

Shipping: The monoclonal antibody trastuzumab biosimilar is shipped with ice pack. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
12 months from date of receipt, -20 to -70°C as supplied.
1 month from date of receipt, 2 to 8°C as supplied.

Background

Trastuzumab, a humanized monoclonal antibody, interferes with the HER2/neu receptor and is mainly used to treat certain breast cancers, especially HER2-positive metastatic breast cancer. Combined with chemotherapy, trastuzumab increases both survival and response rate.

There are four closely related receptor tyrosine kinases in the ErbB family of receptors: EGFR (ErbB-1; HER1 in humans), HER2/c-neu (ErbB-2), Her 3 (ErbB-3) and Her 4 (ErbB-4). Bound by members of the epidermal growth factor family (EGF-family) of extracellular protein ligands, the HER receptors embedded in the cell membrane promote cell growth and division by turning genes on and off. The HER2 pathway stimulates cell proliferation if it normally functions; when HER2 is overexpressed, cell growth accelerates beyond its normal limits, which happens in some cancers, notably certain types of breast cancer.