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The Center for Proteomics develops and evaluates novel proteomic technologies
with the aim of facilitating the translation of basic science to medical
products. The goals of the scientific research in the center are to a) address
safety and efficacy issues of FDA regulated drugs, b) improve the understanding
of disease mechanisms, c) develop tools and assays for fast food safety
evaluation and detection, and d) provide proteomic knowledge to FDA for drug
regulation and food safety evaluation.
The scientists in the center are conducting 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. The technologies are evaluated to determine their reproducibility, accuracy, dynamic ranges, and so on for regulatory needs, biomarker discovery and validation. Various applications include quantitative analysis of un-modified proteins as biomarkers for drug toxicity, efficacy, and engineered nanomaterials. For understanding toxicity mechanisms and identification of modified proteins as biomarkers, scientists in the center have developed or are developing MS-based technologies to quantitatively measure different protein modifications, for example, protein phosphorylation, acetylation, and methylation. These 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. The center staff is also working on 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. The Center of Proteomics is collaborating 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 for the realization of personalized medicine. Contact InformationFor more information, please contact Dr. Li-Rong Yu, at 870-543-7052 or lirong.yu@fda.hhs.gov |
