Cetuximab biosimilar, human EGFR monoclonal antibody

Cetuximab Biosimilar, Human EGFR Monoclonal Antibody

Recombinant Chimeric IgG1 Monoclonal Antibody.
Isotype: Human IgG1 kappa.
Source: The monoclonal antibody cetuximab biosimilar was produced in the cetuximab biosimilar CHO stable cell line.
Specificity/Sensitivity: The monoclonal antibody cetuximab biosimilar specifically binds to the human EGFR.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by cetuximab.
Form of Antibody: 0.2 uM filtered solution, pH 7.2, 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 cetuximab 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

Cetuximab, a chimeric (mouse/human) anti-EGFR monoclonal antibody, is an EGFR inhibitor used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab binds to EGFR and turns off the uncontrolled growth in cancers with EGFR mutations.

Cetuximab can be used for treatment of KRAS wild type colon cancer but has little or no effect in colorectal tumors harboring a KRAS mutation. Before treatment using Erbitux, it is better to do a diagnosis using the real time PCR companion diagnostic test for KRAS, the therascreen KRAS test.

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, EGFR (epidermal growth factor receptor) located on cell surface sends a signal down the MAPK pathway that includes another protein, KRAS (also spelled K-ras). Mutations affecting EGFR and/or KRAS expression or activity could result in cancer. The mutated KRAS continuously sends a growth signal to the downstream pathway, leading to uncontrollable cell division, even if EGFR has been blocked.