Quantitative Evaluation of VEGF in Human Plasma Using ELISA and MSD Platforms for Pharmacodynamic Assessment

Precise quantitative determination of Vascular Endothelial Growth Factor (VEGF) in human plasma is critical for pharmacodynamic (PD) evaluation of anti-VEGF therapeutics. In this study, we developed and optimized two immunoassay platforms, including the enzyme-linked immunosorbent assay (ELISA) and the Meso Scale Discovery (MSD), for estimating VEGF. A direct sandwich ELISA was validated to quantify pharmacodynamic biomarker VEGF in human plasma using the Human VEGF Quantikine Kit, demonstrating a quantification range of 62.5–2000.0 pg/mL and a sensitivity of 47.5 pg/mL. In parallel, a sandwich electrochemiluminescence (ECL) assay was developed using the V-PLEX Plus Human VEGF Kit on the MSD platform, achieving a lower quantification range of 7.7–562.0 pg/mL. Comparative analysis revealed that MSD ECL detection with Sulfo Tag labeling outperformed traditional colorimetric ELISA in terms of signal amplification and dynamic range, making it a valuable tool for PD biomarker analysis. Findings underscore the importance of early platform selection to ensure robust, fit-for-purpose biomarker quantification for clinical pharmacology studies and regulatory submissions.