Betifisolimab Biosimilar - Research Grade

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ICH5397-10mg

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Betifisolimab Biosimilar - Research Grade

Endotoxin

≤ 1.0 EU/mg as determined by the LAL method

Purity

>90% by SDS-PAGE

Species Reactivity

Human

Target

PD-L1

Concentration

>1mg/ml

Isotype

IgG1 - kappa

Host

CHO Cells

Antibodies Against The Same Target

Sequence

https://www.imgt.org/mAb-DB/

Buffer

ICH3002

Uniprot

Q9NZQ7

Shipping Conditions

Blue ice

Background

ICH5397 is a research-grade biosimilar of betifisolimab, supplied as an unconjugated, non-therapeutic analog of the originator anti-PD-L1 antibody for research use only. It is not the clinical drug product and is not intended for diagnostic or therapeutic use. The molecule reproduces the human IgG1/kappa framework and antigen-binding specificity of betifisolimab, which was developed as a pH-dependent monoclonal antibody directed against programmed death-ligand 1 (PD-L1, also known as CD274 or B7-H1). This format makes it a useful reference and comparator reagent for investigators studying PD-1/PD-L1 checkpoint biology, benchmarking novel anti-PD-L1 candidates, or characterizing binding and effector behavior of the originator sequence. The product is manufactured to research-grade specifications with low endotoxin and is available in bulk milligram-to-gram quantities, supporting reproducible, scaled experimental work. As a human-target biosimilar, it is most appropriate for in-vitro and functional applications rather than routine mouse in-vivo dosing. All characterization and application details should be confirmed by the investigator for the intended experimental system. PD-L1 (CD274 / B7-H1; UniProt Q9NZQ7) is a type I transmembrane immune-checkpoint ligand of the B7 family. It is expressed on many tumor cells, antigen-presenting cells, and various stromal and epithelial tissues, and its expression is strongly induced by inflammatory cytokines such as interferon-gamma. By engaging its receptor PD-1 on activated T cells, PD-L1 delivers an inhibitory signal that dampens T-cell proliferation, cytokine production, and cytotoxic activity, promoting peripheral tolerance. Tumors exploit this axis to evade immune surveillance, making PD-L1 a central target in cancer immunotherapy. Antibodies that block the PD-L1/PD-1 interaction can restore effector T-cell function. PD-L1 also binds CD80 (B7-1), adding further complexity to its regulatory role. Because this is a human target, corresponding studies typically use human cells or systems.

Other Names

CD274

Purification Method

This monoclonal antibody was purified using Protein A

Formulation

Sterile, preservative-free, solution in PBS. BSA and Azide free.

Storage

This biosimilar is stable when stored at 2-8°C. For longer term storage (> 3 months) it is recommended to store this antibody at -20°C or -70°C.

Applications

Functional Assays

Application Notes

This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.