Antibodies that target a protein playing a key role in the regulation of cholesterol levels have been introduced by Bio-Rad Laboratories.
The range of type 1 antibodies inhibit the binding of evolocumab (Repatha) to its target – human proprotein convertase subtilisin/kevin type 9 (PCSK9).
These sequence-defined, recombinant antibodies are suitable for developing highly selective and sensitive pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.
Bio-Rad says that evolocumab is a monoclonal antibody used for the treatment of hyperlipidemia, or elevated levels of cholesterol and other lipoproteins.
It binds to PCSK9, preventing its interaction with low-density lipoprotein (LDL) receptors to reduce circulating cholesterol and other lipoproteins.
The company explains that the new range of five anti-evolocumab antibodies includes fully human IgG1 clones and TrailBlazer Antibodies with a SpyTag incorporated into their heavy chain. This enables site-directed conjugation or fast-switching to a bivalent Fab or a full-length Ig-like format within an hour.
It says the antibodies can be used to develop PK bridging enzyme-linked immunosorbent assays (ELISAs) to measure free drug or as a surrogate positive control or reference standard in an ADA assay.
Hilary Latham, Bio-Rad marketing director said: “Bio-Rad’s range of ready-made and well-characterized anti-idiotypic antibodies keeps growing, offering researchers enhanced flexibility for the development of custom bioanalytical drug assays against a wide range of marketed biologic drugs.
“Generated under stringent quality control for batch-to-batch consistency, these antibodies can produce translatable and reproducible results, ensuring assay reliability.”
The company says the recombinant antibodies are generated using the Human Combinatorial Antibody Library (HuCAL) and CysDisplay, a proprietary method of phage display, along with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply throughout the assay lifecycle.
The anti-evolocumab antibodies are approved for in vitro research purposes and for commercial in vitro testing services to support preclinical and clinical drug development.