Bioanalysis Zone

Challenges and approaches in biomarker assays for mitigating variability with improved accuracy and precision


Biomarker assays are becoming increasingly important in pre-clinical research and clinical diagnosis. Biomarkers not only help in early diagnosis, but also in disease prevention, drug target identification and drug response. The fit-for-purpose approach for bioanalytical method validation of biomarker assays is now a well-accepted approach to sufficiently characterize a method for its intended use. There are several challenges one can encounter during method development and validation of biomarker assays. Although commercial kits are available, they need to be thoroughly evaluated for their reliability to measure the analyte of interest in various matrices. Additionally, presence of variable amount of endogenous biomarkers in matrices poses a serious challenge during spike and recovery. Multiple factors can affect the recovery of endogenous biomarkers thereby increasing variability such as such adsorption onto the polypropylene tubes. Critical reagents of the kit must be also well characterized for consistent, reproducible and accurate results.

Manju Saxena, Scientific Director, Intertek Pharmaceutical Services in San Diego and her biomarker assay team describe three case studies of biomarker analyses, highlighting the challenges and demonstrating solutions to mitigate variability during the 2015 AAPS National Biotechnology Conference poster session on Wednesday, June 10th, 2015 (Poster # W3072). The case studies include testing of endogenous biomarkers such as hemoglobin and Aβ-42 in different matrices using ELISA and ECL-based immunoassays.

Request a copy of the poster at:


2015 AAPS National Biotechnology Conference

Poster session: Wednesday June 10th 2015

Poster #W3072

Click here to view the Intertek Pharmaceutical Services company profile.


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