SBIR Phase II: Development of a BioAcoustic Mixing Platform

这个小企业创新研究（SBIR）二期研究项目开发了一种基于声波的混合器，适用于细胞培养的生物反应器和发酵罐。细胞培养和发酵是一个巨大的市场，预计在未来几年将有显著增长。本研究将为该非侵入式、非破坏性混合技术建立最佳设计和操作条件。预计使用这种新型搅拌技术，许多应用的性能可以比最先进的技术提高50%或更高。更广泛的影响将是降低基于生物原料的药品生产成本。由于轨道摇瓶和细胞培养瓶的限制，用于药物生物生产的培养基和工艺开发是昂贵和耗时的，并且使用搅拌槽生物反应器进行。一种能够统一实验室规模和中试规模实验的混合技术将在加快工艺开发的步伐方面具有很高的价值。低频声能在不增加流体动剪应力的情况下显著增强气液质输运。该研究项目将通过量化声波频率对氧传递速率和细胞生长的影响，加强对低频声波混合过程的科学理解。对社会的意义在于，成功的发展是生物技术进程发展步伐的急剧加快。这将导致药品更快的商业化和更低的价格，从而提高整体生活质量。

This Small Business Innovation Research (SBIR) Phase II research project develops a mixer based on sound waves applicable for use in bioreactors for cell culturing and fermentors. Cell culturing and fermentation are large markets where significant growth is forecast over the next several years. This research will establish the optimal design and operating conditions for this non-invasive and non-destructive mixing technology. It is anticipated that performance for many applications can be enhanced by 50% or greater over state-of-the-art technology using this novel agitation technology. The broader impact will be to reduce the costs of pharmaceutical production, when such production is based on biological feedstocks. Media and process development for biological production of pharmaceuticals is costly and time-intensive and performed using stirred-tank bioreactors due to the limitations of orbital shake-flask and cell culture flasks. A mixing technology that could unify laboratory-scale and pilot-scale experiments would be highly valuable in speeding the pace of process development. Low-frequency acoustic energy will dramatically enhance gas-liquid mass transport without increasing hydrodynamic shear stress. The research project will enhance the scientific understanding of low frequency acoustic mixing processes by quantifying the impact of acoustic frequency on oxygen transfer rates and cellular growth. The significance to society that the successful development is a dramatic increase in the pace of biotechnological process development. This will lead to more rapid commercialization of and lower prices for pharmaceutical products that enhance overall quality of life.