Nivolumab 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 nivolumab biosimilar was produced in the nivolumab biosimilar CHO stable cell line.
Specificity/Sensitivity: The in vivo grade nivolumab biosimilar specifically binds to PD-1, antagonizing its interaction with its known ligands PD-L1 and PD-L2.
Applications: ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by nivolumab.
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 nivolumab 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

What is Nivolumab biosimilar research grade? Nivolumab is a humanized IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. Nivolumab Biosimilar uses the same protein sequences as the therapeutic antibody nivolumab.

PD-L1 and PD-L2 (B2-DC or CD273, programmed cell death ligand 2) are the two ligands for the receptor PD-1 (CD279, programmed cell death protein 1).

Nivolumab blocks PD-1 inhibitory signalling to T-cells. It has a long duration of action as it is administered every 2-4 weeks. Patients should be counselled regarding the risk of immune-mediated adverse effects, infusion-related adverse effects, complications of allogenic hematopoietic stem cell transplants, embryo-fetal toxicity.

The ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T-cells, inhibiting the action of these cells. Tumor cells express PD-L1 and PD-L2. Nivolumab binds to PD-1, preventing PD-L1 and PD-L2 from inhibiting the action of T-cells, restoring a patient's tumor-specific T-cell response.