NIST only participates in the February and August reviews.
The goal is to lead innovative projects advancing infrared absorption spectroscopy techniques. We focus on the high-sensitivity characterization of advanced drug products, specifically targeting therapeutic proteins, nucleic acids (RNA and DNA), and complex gene delivery systems. These next-generation therapeutics require highly specific inter- and intra-moleculuar configurations and compositions to ensure clinical efficacy, targeted delivery, and patient safety. Because conventional analytical methods face nontrivial limitations in obtaining reliable, rapid structural measurements of these macromolecules in their native aqueous formulations, we are developing advanced vibrational spectroscopic techniques that overcome these historical barriers. Specifically, we leverage cutting-edge quantum cascade laser (QCL-IR) spectroscopy to achieve significantly better concentration sensitivity than traditional FT-IR methods. This non-destructive optical method enables the precise measurement of structural backbones and formulation stability directly in complex aqueous solutions. Ultimately, our work will provide the biopharmaceutical industry with essential analytical tools to accelerate the development, formulation screening, and quality control of next-generation biologics and gene therapies.
[1] 1. B. Chon, S. Xu, Y. J. Lee, Compensation of strong water absorption in infrared spectroscopy reveals the secondary structure of proteins in dilute solutions, Anal. Chem.93, 2215 (2021).
[2] 1. S.-M. Kim, Y.-R. Chang, J. Melby, Y. J. Kim, D. Davis, Y. J. Lee, Quantum Cascade Laser Infrared Spectroscopy for Glycan Analysis of Glycoproteins, Anal. Chem.96, 13120 (2024).
Infrared Spectroscopy; Gene Delivery; Nucleic Acid; RNA; DNA; Protein Drug; High Sensitivity; QCL-IR Spectroscopy
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