SBIR Phase I: 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。一旦进入市场，我们的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)或石墨碳基柱能力的客户，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)和滥用药物(例如，大麻)。该SBIR第一阶段项目建议建立用于反相高效液相色谱的化学交联型全碳柱材料的技术可行性。色谱技术在开发救命药品和医疗疗法、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关键作用。反相高效液相色谱柱采用疏水固定相。典型的硅胶反相高效液相色谱柱不耐用，受到pH和温度升高的挑战，缺乏对高极性和密切相关结构的足够保留。较新的石墨炭高效液相色谱柱昂贵得令人望而却步，而且既不能扩展也不能功能化以提高选择性。我们技术的关键区别在于分子表面水平，我们的新型专利制造技术直接将碳纳米材料与共价键连接起来，生产可扩展的全碳柱材料。我们在第一阶段的总体目标是确定最佳的柱填充条件，并表征柱的色谱性能随pH和温度的变化以及分离结构相似的小分子化合物和生物制品的能力。成功完成拟议的研发计划将使我们能够最终确定高度差异化的全碳纳米材料柱原型，这些原型将提供无与伦比的化学和热稳定性、同类最佳的回收、出色的分离效率，并以显著较低的成本延长柱寿命。

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 HPLC column market. Upon market entry, our 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) and drugs of abuse (e.g., cannabis).This SBIR Phase I project proposes to establish the technical feasibility of a chemically-crosslinked all carbon column material for reverse phase HPLC. Chromatography technology plays a key 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. Reversed-phase HPLC columns employ a hydrophobic stationary phase. Typical silica-based reverse phase HPLC columns are not durable, are challenged by elevated pH and temperature and lack sufficient retention for highly polar and closely related structures. The newer graphitic carbon HPLC columns are prohibitively expensive and neither scalable nor functionalizable for improved selectivity. Our technology's key differentiator is at the molecular surface level, where our novel proprietary fabrication technology directly connect carbon nanomaterials with covalent bonds, producing scalable all-carbon column materials. Our overall objective during Phase I is to identify the optimal column packing conditions and characterize the chromatographic performance of the columns as a function of pH and temperature and ability to separate structurally similar small compounds and biologics. Successful completion of the proposed research and development plan will allow us to finalize highly differentiated all-carbon nanomaterial column prototypes that will offer unparalleled chemical and thermal stability, best-in-class recovery, excellent separation efficiency and increased column longevity at a significantly lower cost.