App Note: 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 that detects human monoclonal IgG antibodies and subclasses, compatible with the most common species used in the pre-clinical phase and the wide range of analyte concentrations in preclinical samples, and consumes minimal amounts of precious sample for example from mouse serum. 

 Further development has led to a second-generation, Gyrolab 2G Generic PK Kit. This Application Note 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.