Jiangnan Peng Awarded $914k from FDA to Assess and Authenticate Botanical Products
Dr. Jiangnan Peng, Assistant Professor of Chemistry, has been awarded $914,600 from the Food and Drug Administration as a cooperative agreement for two years to develop methods to authenticate and assess botanical drug products. The proposal, entitled "NMR- and SFC/MS-based Metabolomics Approaches for the Authentication and Assessment of the Quality of Botanical Raw Materials," is a collaborative effort of several faculty members of the School, Dr. Fasil Abebe, Assistant Professor of Chemistry and Dr. Saroj Pramanik, Associate Professor of Biology.
The quality of botanical drug products (BDP) is dependent on the quality of the botanical raw material (BRM) as well as the extraction, formulation and manufacturing processes used. BRM plays a critical role in the development of BDP with high quality and batch consistency. It is well known that the high variability found in BRMs is one of the main problems related to the quality of the final product and depends on genetic and environmental factors, such as growing, harvesting and storage conditions. In addition, the possibility of misidentification of the source material, or even the possibility of fraudulent adulteration, are very challenging issues for quality assurance. Therefore, quality control of BRM cannot be overemphasized.
Current methods of choice used for authentication and identification of plant species include conventional organoleptic, macroscopic, and microscopic examination, phytochemical evaluation (identification test and assay), and genetic taxonomic method (e.g., DNA barcoding test). However, plants with unknown morphology, such as roots, bark, or ground of mixtures of different plant samples from unknown sources cannot be identified from morphological characteristics. Chemical identification tests based on the analysis of one or a few compounds as markers cannot represent the whole chemical profile of plant parts used as BRM, since each plant or even different parts from the same plant (e.g., leaves, roots, or rhizome) consists of tons of chemical components. Therefore, advanced techniques, such as NMR- or SFC/MS metabolomics analysis, are needed to demonstrate the global chemical profile for authentication and identification purposes.
The main objective of the current proposal is to (1) develop NMR- and SFC/MS-based metabolomics analysis methods to authenticate and assess the quality of BRM; (2) build up a comprehensive metabolomics database as a reference repository for evaluating the quality of BRM used in the BDP or determining the “similarity” of BRM used in generic BDP to its reference product. The outcome of the proposal is to provide comprehensive tools implemented to ensure BRM with constant and reliable quality for the development of BDP and help facilitate regulatory assessment on BDP, which will support the agency for regulatory decision-making and benefit public health with safe and high-quality BDP.
Read more about Dr. Peng's grant award here.