SBIR Phase I: Novel Multiplexed Microsphere Assays

这个小型企业创新研究（SBIR）第一阶段项目解决了对单一二氧化硅基复合微球的需求，这种微球目前市场上没有，因为固体二氧化硅微球必须在高温（300 ℃）下烘烤，破坏内部有机染料。 虽然聚苯乙烯微球是生物测定中使用的最普遍的微球，但二氧化硅微球由于各种原因而被期望，并且玻璃基质本身相对于基于聚合物的材料提供了显著的优点。总体研究目标是开发一种低温溶胶-凝胶生产工艺，该工艺将生产出更均匀的多重微珠阵列检测（MBAA）产品，其特征在于与目前可用的现有产品相比具有更高的化学一致性。 随着总体成功，该计划将创造生产能够转化为至少10个子微球的单一母体微球的能力，每个子微球具有独特和可区分的自体荧光特性。 这种过渡到一个新的制造工艺的二氧化硅为基础的微球将解决许多问题遇到的高温微球制造，同时降低成本的限制与今天？该项目的更广泛的影响/商业潜力是针对多重微球测定的技术限制和成本约束，以比其他生物测定产品更少的时间和精力提供更多的数据。目前制造这些微球的方法非常繁琐、效率低下，并且需要数百个制造步骤，每个步骤都需要质量控制以确保整体产品的可靠性。这些组合的制造步骤使得这些产品非常昂贵。 因此，生产多重微球的更精简的方法将转化为显著降低的生产成本，这最终将使这些微球对研究人员和临床医生来说更实惠。 这将允许临床医生和研究人员扩大使用多重测定，并加速发现过程，特别是在蛋白质组学和基因组学领域。此外，这项技术预计将增加创新的医学研究，降低诊断成本，并加快有前途的探索领域。 如果成功，这一平台将刺激竞争，创造新的就业机会，并提供重要的贸易和出口机会。

This Small Business Innovation Research (SBIR) Phase I project addresses the need for a single silica-based multiplexed microsphere that is not available on the market today because solid silica microspheres must be baked at elevated temperatures (300C), destroying the internal organic dyes. While polystyrene microspheres are the most prevalent microsphere used in bio-assays, silica microspheres are desirable for a wide variety of reasons and the glass matrix itself offers significant advantages relative to polymer-based materials. The overall research objective is to develop a low-temperature sol-gel manufacturing process that will produce a more uniform Multiplexed Bead Array Assay (MBAA) product characterized by greater chemistry consistency as compared to existing product available today. With overall success, this program will create the ability to produce a single parent microsphere capable of being transformed into at least 10 daughter microspheres, each with a unique and distinguishable autofluorescence characteristic. This transition to a novel manufacturing process for silica-based microspheres will solve many of the problems encountered with high-temperature microsphere manufacturing, while decreasing the cost limitations associated with today?s multiplexed microspheres.The broader impact/commercial potential of this project is to target the technical limitations and cost constraints of multiplexed microsphere assays to deliver more data with less time and effort than other bioassay products. Current approaches to manufacturing these microspheres are very cumbersome, inefficient, and require literally hundreds of manufacturing steps and each requiring quality control to ensure overall product reliability. These combined manufacturing steps make these products very expensive. Therefore, a more streamlined approach to producing multiplexed microspheres would translate into significantly decreased production costs, which would ultimately make these microspheres more affordable to researchers and clinicians. This would allow for the expanded use of multiplexing assays by clinicians and researchers and accelerate the discovery process, especially in the proteomic and genomic fields. Additionally, this technology is expected to increase innovative medical research, reduce diagnostic costs and expedite promising areas of exploration. If successful, this platform would spur competition, create new jobs and provide significant trade and export opportunities.