BioPrism - An Optical Chromatograph

描述（由申请人提供）：Optofluidics Inc.建议开发一种近场光学色谱仪，BioPrism，并将其应用于纳米医学中颗粒涂层稳定性的表征。根据clinicaltrials.gov的数据，大约10%的临床试验涉及纳米颗粒，美国国家科学基金会预测，未来近一半的药物将含有纳米技术成分。转向基于纳米颗粒的药物制剂的一些主要动机是与较大的相对表面积相关的较高活性和稳定分散固有不溶性疏水材料的能力。实现这两种潜在的革命性能力的关键是开发稳定的纳米颗粒涂层。不这样做会导致颗粒团聚、聚集并最终导致纳米毒性。正如我们在提案中通过一系列行业报告、顶级专家的引用和具体案例研究所描述的那样，明显缺乏可以快速评估纳米颗粒涂层的仪器，开发这样的系统既可以缩短新药上市时间，又可以提高患者安全性。BioPrism方法使用激光推动颗粒沿着波导表面，基于康奈尔大学授权的技术，并由Optofluidics进一步开发。简而言之，颗粒和波导之间的表面相互作用影响颗粒移动性和停留时间，从而能够以与吸附色谱相同的方式进行分离。然而，正如我们在提案中所证明的，使用光学力来驱动分离过程使得尺寸分辨率能够比现有色谱系统可能的尺寸分辨率增加一个潜在的数量级。这种明显更精细的分辨率为我们提供了一个潜在的破坏性优势，使颗粒涂层的变化的直接测量，而不是依赖于二阶后期效应的观察，如团聚，像现有的仪器。在第二阶段工作结束时，我们将开发出一种BioPrism试剂盒，该试剂盒既经过我们的行业合作伙伴和合作者的验证，又与我们现有的仪器产品线兼容，从而促进我们的上市之路。

DESCRIPTION (provided by applicant): Optofluidics Inc. proposes to develop a near field optical chromatograph, the BioPrism, and apply it to the characterization of particle coating stability in nanomedicine. According to clinicaltrials.gov, about 10% of all clinical trials involv nanoparticles and the National Science Foundation has predicted that nearly half of future pharmaceuticals will have some nanotechnology component. Some of the prime motivations for moving to nanoparticle based drug formulations are the higher activity associated with larger relative surface areas and the ability to stably disperse inherently insoluble hydrophobic materials. Critical to enabling both these potentially revolutionary capabilities is the developmen of stable nanoparticle coatings. Failure to do so results in particle agglomeration, aggregation and ultimately nanotoxicity. As we describe in the proposal through a series of industry reports, quotes from top experts, and specific case studies, there is a distinct lack of instrumentation tha can rapidly assess nanoparticle coatings and the development of such a system could both reduce the time to market for new drugs and increase patient safety. The BioPrism method uses laser light to push particles along the surface of a waveguide and is based on technology licensed from Cornell University and further developed by Optofluidics. Briefly, the surface interaction between the particle and the waveguide affects particle mobility and residence time, enabling separation in the same way as adsorption chromatography. As we demonstrate in the proposal however the use of optical forces to drive the separation process enable a potential order of magnitude increase in size resolution over that possible with existing chromatography systems. This significantly finer resolution provides us with a potentially disruptive advantage, enabling the direct measurement of changes in particle coatings rather than relying on the observation of second order late stage effects, such as agglomeration, like existing instruments do. At the conclusion of this Phase II effort we will have developed a BioPrism cassette that is both validated by our industry partners and collaborators and compatible with our existing instrument product line thereby facilitating our path to market.