USP conducts early stage evaluations of new and emerging technologies and trends to identify areas and potential needs for compendial standards. These evaluations also include assessment of analytical technologies that may advance reference standards characterization and enhance compendial testing performance. The evaluation process aids in the determination of potential standards and analytical technology applications that can then be developed and integrated through the USP standard-setting processes. We achieve this by leveraging existing USP resources, and augmenting our capacity through collaboration with external organizations and external expertise and capabilities.
We are currently working on the following two projects. Additional topics including digital health, gene/cell therapy, and 3D printing are being explored to better understand their implications and USP’s role in providing guidance and standards.
Quantitative Nuclear Magnetic Resonance (qNMR)
qNMR has the potential to not only improve efficiency of reference standard characterization and potentially streamline compendial testing but also provide higher order evaluation of the reference materials. Currently, USP is working with external experts to conduct pilot studies and establish a roadmap for USP internal implementation of the qNMR technology.
In addition to these pilot studies, USP is actively engaging with leading industry stakeholders and participating as a convener at the annual qNMR Summit.
Research Fellow - Yang Liu
Yang Liu received the Ph.D. degree (Pharmacognosy) from University of Illinois at Chicago, College of Pharmacy, where he worked with Professor Guido Pauli, and studied quantitative NMR (qNMR), countercurrent chromatography, and eutectic phenomenon in natural products.
Yang Liu is experienced in qNMR applications, including identification and quantification of natural products, synthetic APIs, and natural/synthetic polymers. As USP Global Fellow in 2017, he has worked on a project about reference standard determinations using qNMR and development of digital NMR reference standards in Prof. Pauli’s lab. In 2018, he has transited the project to USP Rockville campus, and been honored as USP qNMR Fellow.
USP is exploring DNA Identification methodologies as an orthogonal method for species identification for botanical dietary supplements. This includes evaluating appropriate methods and associated reference standards and botanical materials in accord with USP’s goal of disseminating transparent public standards to meet regulatory requirements. USP incorporated DNA-based methods in General Chapter <563> Identification of Articles of Botanical Origin, and published a Stimuli article illustrating the methods, and their strength and limitations.
Research Fellow - Ning Zhang
Dr. Ning Zhang is a scientist working on DNA testing method development. Dr, Zhang recieved his Ph.D degree in 2009 from the Chinese Academy of Sciences, Beijing. To date, Dr. Zhang has published 20 peer-reviewed papers and was cited over 600 times as of June 2018. His research areas span from plant evolutionary biology to utilizing DNA testing methods to identify botanical raw materials.
Global Substance Registration System (G-SRS)
USP is exploring opportunities to implement the Global Substance Registration System (G-SRS) as the primary means of modernizing the processes and methods by which USP identifies, curates, and publishes fundamental data elements related to substances. This work will also align with current informatics standards that have regulatory support.
Research Fellow - Andrew Grothen
Andrew Grothen is a pharmacist by training, graduating as a Doctor of Pharmacy from the University of Wyoming School of Pharmacy in 2014. He worked as a community pharmacist in western Nebraska before becoming a Cancer Research Training Award Fellow with the National Cancer Institute, where he gained experience in pharmacy nomenclature and surveillance informatics and helped to develop and curate the Observational Research in Oncology Toolbox as part of the Surveillance Research Program.