Pembrolizumab biosimilar, human PD-1 monoclonal antibody

Recombinant Humanized IgG4 Monoclonal Antibody.
Isotype: Human IgG4 kappa.
Source: The anti-human programmed cell death protein 1 (PD-1) monoclonal antibody pembrolizumab biosimilar was produced in the pembrolizumab biosimilar CHO stable cell line.
Specificity/Sensitivity: The in vivo grade pembrolizumab biosimilar specifically binds to the programmed cell death protein 1 (PD-1 or PD1), antagonizing its interaction with its known ligands PD-L1 or PDL1, and PD-L2 or PDL2.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by pembrolizumab.
Form of Antibody: 0.2 uM filtered solution, pH 5.5, 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 pembrolizumab 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

Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptor. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype with the containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. Pembrolizumab Biosimilar uses the same protein sequences as the therapeutic antibody pembrolizumab.