Effective tools for drug monitoring assays

Sensitive and reproducible pharmacokinetic (PK) and immunogenicity assays are required as part of the complex and lengthy development process for biotherapeutic proteins. These assays are included in a range of approaches applied to understand the nature and properties of the drug as well as the induction of anti-drug antibodies (ADA) against the target, which can cause adverse events and loss of efficacy. In this application note, Bio-Rad explores the use of fully human, anti-idiotypic antibodies for PK and immunogenicity assays.