The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project will be the development of high-performance all-carbon reverse-phase high-performance liquid chromatography (HPLC) column packing material. Customers of the $1.3 Billion/year HPLC column market include life science, biochemical, industrial, nutritional safety, environmental, agricultural, process engineering, academic and governmental organizations. Reversed-phase columns account for the majority of the HPLC column market. Chromatography technology plays a vital role in the development of life-saving pharmaceutical products and medical therapies, ensuring the safety of our food and water, protection of our environment, and guarding public health. The project will focus on the scale-up, and market validation of all carbon powder-packed reverse phase HPLC columns. The successful outcomes of Phase II will: a) Lay the foundation for scale-up manufacturing of initial product and accelerate its commercialization. b) Engage pharmaceutical end-users for beta testing to validate the value proposition, and c) Provide scientific insights that will serve as the guiding principles for the synthesis of column packing materials for other chromatography applications such as preparative chromatography, and Ultra-high HPLC.
This SBIR Phase II project proposes to focus on crucial technical steps that will allow the commercial deployment of chemically-crosslinked all carbon powder packed reverse phase column packing material. Upon market entry, the technology will attract customers whose analysis requirements fall outside the capabilities of current silica- (Hydrophobic alkyl chains typically comprising of 18 carbon atoms (C18) bonded to silica support) or graphitic carbon-based columns as well as those who are seeking faster more efficient analysis at a lower cost. It will also attract customers seeking next-generation performance capabilities for separation of structurally similar compounds, biologics, biobetters, or biosimilars. Molecules would include geometric isomers and diastereoisomers (e.g., chiral drugs such as thalidomide), biogenic (e.g., catecholamines or other hormones that are modulated in many neurologic disorders such as Alzheimer Disease). Macromolecules include structurally similar compounds (e.g., hemoglobin variants in sickle cell anemia) and many drug metabolites (e.g., glucuronide in opioid metabolites).
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.