Accelerate throughput in therapeutic antibody development with an improved generic PK assay

The development of recombinant IgG therapeutic drugs is challenging and often involves several candidates per program together with reagent selection for assay development. In addition, the safety and toxicology parameters of lead candidates must be evaluated in two pre-clinical species, such as mouse and cynomolgus monkey (cyno). Sample volumes may be limited, and analyte levels can vary greatly. The Gyrolab^® Generic PK Kit was developed to meet these requirements to determine therapeutic levels in studies throughout the early and pre-clinical development of recombinant human intact antibodies of different IgG subclasses in serum matrices from a range of species. Further development has led to a second-generation kit, Gyrolab 2G Generic PK Kit. In this application note, Gyros Protein Technologies highlights the improvements achieved, including the increased dynamic range and the flexibility in dynamic range enabled with the option of using Gyrolab Bioaffy™ 1000 HC CD or other CD sizes including the Gyrolab Bioaffy 4000 HC CD. These benefits will help to streamline workflows by reducing the need for re-analysis when analyzing study samples with a wide range of analyte concentrations.