BioPrism - An Optical Chromatograph

描述(申请人提供)：光流控公司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，所有临床试验中约有10%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包含一些纳米技术成分。转向基于纳米颗粒的药物制剂的一些主要动机是与更大的相对表面积相关的更高的活性以及稳定分散固有的不溶性疏水材料的能力。实现这两种潜在革命性能力的关键是开发稳定的纳米颗粒涂料。如果做不到这一点，就会导致颗粒聚集、聚集，最终导致纳米毒性。正如我们通过一系列行业报告、顶级专家的引述和具体的案例研究在提案中所描述的那样，目前明显缺乏能够快速评估纳米颗粒涂层的仪器，而开发这样的系统既可以缩短新药的上市时间，又可以提高患者的安全性。生物棱镜方法使用激光将粒子沿波导表面推送，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会影响颗粒的迁移率和停留时间，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展示的那样，使用光学力来驱动分离过程能够使尺寸分辨率比现有的层析系统潜在地增加数量级。这种明显更精细的分辨率为我们提供了潜在的颠覆性优势，使我们能够直接测量颗粒涂层的变化，而不是像现有仪器那样依赖于观察二阶后期效应，如团聚。在第二阶段的工作结束时，我们将开发出一种经过我们的行业合作伙伴和合作者验证的BioPrism盒式磁带，并与我们现有的仪器产品线兼容，从而促进我们的市场之路。

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.