Anti-PD-1 (Pembrolizumab biosimilar - IgG4 (S228P) isotype)

Human IgG4 (S228P) engineered monoclonal antibody (mAb) against human PD-1

Anti-hPD1-Pem-hIgG4 (S228P) features the constant region of the human IgG4 (S228P) isotype and the variable region of pembrolizumab. Pembrolizumab is a humanized IgG4 monoclonal antibody that contains an engineered hinge region mutation (S228P) designed to prevent the exchange of IgG4 molecules. This antibody targets the PD-1 receptor found on activated T cells, B cells, and myeloid cells. Under normal physiological conditions, PD-1 negatively regulates T cell activation thereby preventing autoimmunity [1].

Under pathological conditions, cancer cells produce PD-L1 (programmed cell death 1 ligand 1), the agonist that binds and activates PD-1. Activated PD-1 enables the cancer cells to evade the immune system. Pembrolizumab binds and blocks the activation of the PD-1 receptor, thereby resulting in the activation of T cells [2]. Pembrolizumab has been approved by the FDA for the treatment of metastatic malignant melanoma and is currently under regulatory review in the EU [3].

Anti-hPD1-Pem-hIgG4 (S228P) was generated by recombinant DNA technology. It has been produced in CHO cells and purified by affinity chromatography.

References:

1. McDermott D. & Atkins M. 2013. PD-1 as a potential target in cancer therapy. Cancer Med. 2(5): 662–673.
2. Tumeh PC. et al., 2014. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 515(7528):568-71.
3. Poole RM., 2014. Pembrolizumab: first global approval. Drugs. 4(16):1973-81.

Specifications

Specificity: Targets cells expressing human PD-1

Clonality: Monoclonal antibody

Isotype: Human IgG4 (S228P), kappa

Source: CHO cells

Formulation: 0.2 μm filtered solution in a sodium phosphate buffer with glycine, saccharose and stabilizing agents.

Purity: Purified by affinity chromatography with protein G

Applications: Anti-hPD1-Pem-hIgG4 (S228P) binds and blocks ligand activation of the PD-1 receptor found on the surface of activated T cells.

Quality control:

• The recognition of PD-1 with this antibody has been tested using flow cytometry.
• The absence of bacterial contamination (e.g. lipoproteins and endotoxins) has been confirmed using HEK-Blue™ TLR2 and HEK-Blue™ TLR4 cells.

Contents

Anti-hPD1-Pem-hIgG4(S228P) antibody is provided azide-free and lyophilized.

• 100 µg anti-hPD1-Pem-hIgG4(S228P) purified antibody

Product is shipped at room temperature.

Store lyophilized antibody at -20 °C.

Lyophilized product is stable for at least 1 year