Overcome Assay Drift in PK ELISA

Overcoming Assay Drift and Multiple Matrix Interference Challenges in a PK ELISA

Authors: Simone S. Cummings, PhD and Gwendolyn Wise-Blackman, PhD, Catalent

Absence of assay drift in ELISAs needs to be demonstrated by executing low, mid, and high QCs at the beginning and end of a 96-well plate, especially in the presence of complex biological matrices. Catalent presents a case study demonstrating a Design of Experiment (DOE) approach to develop a sensitive ELISA to detect a therapeutic pegylated protein (TPZ) in monkey, rat, and human serum that surmounts the challenge of assay drift and matrix interference. Results were able to validate an ELISA for the detection of IPZ in monkey, rat, and human serum fluid that was highly sensitive, linear, accurate, precise, and rugged.