SBIR Phase II: All-Carbon, Chemically Cross-Linked 3D Nano Assemblies for Liquid Chromatography

这个小型企业创新研究(SBIR)项目的更广泛影响/商业潜力将是开发高性能全碳反相高效液相色谱柱填料。每年13亿美元的高效液相色谱柱市场的客户包括生命科学、生化、工业、营养安全、环境、农业、过程工程、学术和政府组织。反相柱占据了高效液相色谱柱市场的大部分。层析技术在开发救命药物和医疗疗法、确保我们的食品和水的安全、保护我们的环境和保障公众健康方面发挥着至关重要的作用。该项目将专注于所有碳粉填充的反相高效液相色谱柱的放大和市场验证。第二阶段的成功成果将：a)为初始产品的扩大生产奠定基础，并加快其商业化进程。B)邀请制药终端用户进行Beta测试以验证价值主张，以及c)提供科学见解，这些见解将作为其他层析应用的柱填充材料合成的指导原则，如制备层析和超高高效液相。该SBIR第二阶段项目建议将重点放在关键的技术步骤上，以实现化学交联型全碳粉末填充反相柱填料的商业部署。一旦进入市场，该技术将吸引那些分析要求超出当前二氧化硅(通常由18个碳原子(C18)键合在二氧化硅载体上的疏水烷基链)或石墨碳基色谱柱的客户，以及那些寻求以更低成本进行更快、更高效分析的客户。它还将吸引寻求下一代性能能力的客户，用于分离结构相似的化合物、生物制品、生物化合物或生物仿制药。分子将包括几何异构体和非对映异构体(例如，手性药物，如沙利度胺)，生物异构体(例如，儿茶酚胺或其他在许多神经疾病中调节的激素，如阿尔茨海默病)。大分子包括结构相似的化合物(例如，镰状细胞性贫血中的血红蛋白变体)和许多药物代谢物(例如，阿片代谢物中的葡萄糖醛酸苷)。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.