Adalimumab biosimilar, human TNF alpha monoclonal antibody

Recombinant Humanized IgG1 Monoclonal Antibody.
Isotype: Human IgG1 kappa.
Source: The monoclonal antibody adalimumab biosimilar was produced in the adalimumab biosimilar CHO stable cell line.
Specificity/Sensitivity: The monoclonal antibody adalimumab biosimilar specifically binds to the human TNF alpha.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by adalimumab.
Form of Antibody: 0.2 uM filtered solution, pH 5.2, 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 adalimumab 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

Adalimumab, the first fully human monoclonal antibody drug approved by FDA, binds to TNFα, inactivates TNF receptors, and downregulates the inflammatory reactions associated with a variety of autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, moderate to severe chronic psoriasis and juvenile idiopathic arthritis.

Mainly produced by activated macrophages (M1), Tumor necrosis factor (TNF, cachexin, cachectin, tumor necrosis factor alpha, TNFα) plays important roles in the regulation of immune cells. As a member of a group of cytokines that stimulate the acute phase reaction, TNF is involved in systemic inflammation and able to induce fever, apoptotic cell death, cachexia, inflammation, and to inhibit tumorigenesis and viral replication and respond to sepsis via IL1 & IL6 producing cells. Dysregulation of TNF expression could have serious impact in a variety of human diseases including Alzheimer's disease, cancer, major depression and inflammatory bowel disease.