Proteomics

The Center for Proteomics develops and evaluates novel proteomic technologies with the aim of facilitating the translation of basic science to medical products. The Center collaborates with other FDA centers, industry, other government agencies, and academic institutions to apply proteomic technologies to biomedical research to facilitate drug regulation, food-safety evaluation, and improve predictability of drug toxicity.

Research Goals

• Address safety and efficacy issues of FDA-regulated drugs
• Improve the understanding of disease mechanisms
• Develop tools and assays for fast food-safety evaluation and detection
• Provide proteomic knowledge to FDA for drug regulation and food-safety evaluation

Ongoing Research

• Qualitative and quantitative proteomic analyses of cells, tissues, and organisms using multi-dimensional separation and mass spectrometry (MS). 
• More detailed proteomic characterization of specific organelles is often achieved by subcellular fractionation. Both matrix-assisted laser desorption ionization (MALDI) and electrospray ionization (ESI) are employed to generate peptide/protein ions; however, nano-flow HPLC coupled with various MS (e.g., 3D or 2D linear ion trap with electron transfer dissociation (ETD), quadrupole time-of-flight (Q-TOF), and hybrid linear ion trap-Orbitrap MS) is more frequently used for quantitative analyses of complex proteome samples and protein complexes. 
• Technologies are evaluated to determine their reproducibility, accuracy, dynamic ranges, etc. for regulatory needs, biomarker discovery, and validation. Various applications include quantitative analysis of unmodified proteins as biomarkers for drug toxicity, efficacy, and engineered nanomaterials. 
• Development of MS-based technologies to quantitatively measure different protein modifications such as protein phosphorylation, acetylation, and methylation to understand toxicity mechanisms and identification of modified proteins as biomarkers.
• Novel quantitative proteomic and phosphoproteomic technologies are being applied to the identification and validation of modified protein as biomarkers for areas including early cancer detection, toxicity assessment, and efficacy prediction. 
• Improvements in throughput of MS-based proteomic experiments to permit a high volume of samples to be analyzed for both dose- and time-dependent toxicological studies.

Contact Information

For more information, please contact Dr. Li-Rong Yu, at 870-543-7052 or lirong.yu@fda.hhs.gov.