SBIR Phase I: Novel Multiplexed Microsphere Assays

这个小型企业创新研究(SBIR)第一阶段项目满足了对单一二氧化硅复合微球的需求，这种微球目前在市场上是买不到的，因为固体二氧化硅微球必须在高温(300℃)下烘焙，破坏内部的有机染料。虽然聚苯乙烯微球是生物分析中最常用的微球，但由于各种原因，二氧化硅微球是可取的，而且玻璃基质本身相对于聚合物基材料具有显著的优势。总体研究目标是开发一种低温溶胶-凝胶制造工艺，该工艺将产生与现有产品相比具有更高化学一致性的更均匀的多路复用珠阵列分析(MBAA)产品。随着该计划的全面成功，该计划将创造出生产单亲微球的能力，该微球能够转化为至少10个子微球，每个都具有独特的和可区分的自发荧光特性。这种向新型二氧化硅微球制造工艺的转变将解决高温微球制造中遇到的许多问题，同时降低与今天的S多路复用微球相关的成本限制。该项目的更广泛的影响/商业潜力是针对多路复用微球分析的技术限制和成本限制，以比其他生物检测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，需要数百个制造步骤，每个步骤都需要质量控制，以确保产品的整体可靠性。这些组合的制造步骤使得这些产品非常昂贵。因此，一种生产复合微球的更简化的方法将转化为显著降低生产成本，这最终将使研究人员和临床医生更容易负担得起这些微球。这将允许临床医生和研究人员更广泛地使用多路分析，并加快发现进程，特别是在蛋白质组和基因组领域。此外，这项技术预计将增加创新的医学研究，降低诊断成本，并加快有前景的探索领域。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.