Biosimilar Characterization

Biosimilar Characterization Methods

As part of the drug development program, the biosimilar is compared to the reference product to ensure that there are no clinically meaningful differences in terms of safety, efficacy, and immunogenicity, including the titer and reactivity of anti-drug antibodies (ADA) produced in vivo. The results form part of the totality of evidence required by regulatory agencies. These data must be robust; therefore the reagents used must meet high standards.

Bio-Rad’s antibiotherapeutic antibody reagents for ADA and PK assay development are selected in vitro from the synthetic Human Combinatorial Antibody Libraries (HuCAL). Guided selection strategies enable the generation of fully human, highly specific inhibitory and noninhibitory anti-idiotypic antibodies and specialized drug-target complex binders. These different types of antibodies enable development of PK assays to detect free or total drug, or drug bound to its target. Additionally, the inhibitory antibodies can be used as reference standards in an ADA assay, replacing the need to source antibodies raised in animals.

Bio-Rad provides an expanding portfolio of antibodies against marketed monoclonal antibody drugs and a custom service for additional specificities. Our QC process incorporates several relevant published best practices, aiding with critical reagent life cycle management and characterization and the maintenance of optimal assay performance over time.