Daratumumab biosimilar, human CD38 monoclonal antibody

Recombinant Humanized IgG1 Monoclonal Antibody.
Isotype: Human IgG1 kappa.
Source: The anti-human CD38 monoclonal antibody daratumumab biosimilar was produced in the daratumumab biosimilar CHO stable cell line.
Specificity/Sensitivity: The in vivo grade daratumumab biosimilar specifically binds to the human CD38 protein, causing cells to apoptose via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer or antibody-dependent cellular phagocytosis.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by daratumumab.
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 research grade daratumumab 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

Daratumumab Biosimilar uses the same protein sequences as the therapeutic antibody daratumumab.

Daratumumab (Anti-Human CD38) is the first-in-class human-specific anti-CD38 monoclonal antibody. Daratumumab has anti-multiple myeloma (MM) effect. Daratumumab impairs MM cell adhesion, which results in an increased sensitivity of MM to proteasome inhibition.