By Sino Biological
Therapeutic monoclonal antibodies have emerged as the fastest-growing class of therapeutics since the mid-1980s from the increasing number of pharmaceutical companies seeking more drug modalities to extend their pipelines. Additionally, biosimilars now have more opportunities to enter the market as patents of some blockbuster monoclonal antibodies begin to expire. Given this context, assessing the safety and efficacy of biotherapeutics has become imperative during the drug-development process. In particular, pharmacokinetic (PK) and anti-drug antibody (ADA) assays are conducted to study and evaluate new drug candidates and biosimilars. For PK/ADA assays, anti-idiotype antibodies (Anti-IDs) are powerful tools to measure the concentration of antibody drugs in patient samples and serve as positive controls for anti-drug antibodies (ADA).
Anti-IDs in Pharmacokinetic (PK) Assays
Pharmacokinetics (PK) describes and characterizes the four dif…