Development of a PK Assay - A Case Study from ELISA to MSD to Gyrolab

Labcorp Drug Development was required to develop a pharmacokinetics (PK) assay. A PK enzyme-linked immunosorbent assay (ELISA) had previously been developed; however, Labcorp recommended that the assay be transferred to Meso Scale Discovery (MSD) format to gain more sensitivity. In addition, the ELISA was a homogenous format, which is prone to prozone effects that are not suitable in a PK assay. The initial MSD PK assay format utilised the same anti-Idiotype (anti-ID) for both detection and capture antibody. Multiple Design of Experiments (DoEs) were carried out, which determined that the optimal biotinylated antibody concentration was greater than 50 µg/mL.