I-Corps: Commercialization study of Marangoni Mediated Lyopreservation

这个I-Corps项目的更广泛的影响/商业潜力是评估一种技术的市场潜力，这种技术基本上可以在没有冷藏的情况下储存和运输具有生物和临床意义的分子。目前，缺乏适当的冷链物流基础设施在地理上限制了关键生物分子的分销和储存。一项能够使重要生物分子在室温下稳定的技术的开发和商业应用为该领域和发展中地区的高灵敏度诊断设备打开了大门。 此外，生物制剂在室温下的稳定性可以显著降低运输和储存成本，从而降低最终用户对药物的总体定价。基于这种技术的成功实施的商业战略可以为在任何地方提供高质量的医疗保健提供强有力的案例。这个I-Corps项目基于一种新的方法，用于创建高度均匀的玻璃化（玻璃状）涂层，以保存和保护温度敏感的生物制品，包括细胞和蛋白质。围绕薄膜形式的生物分子形成均匀的玻璃化环境可以阻止降解化学反应并能够储存。薄膜玻璃化技术主要依赖于含有生物分子的基底的优先干燥。该技术利用碳水化合物为基础的配方，促进快速玻璃化在干燥状态。除生物分子外，使用该方法在环境温度下玻璃化的肝细胞癌（HepG 2）细胞已被证明在处理后成功地保留其活力。

The broader impact/commercial potential of this I-Corps project is to evaluate the market potential of a technology that can essentially store and transport molecules of biological and clinical significance without refrigeration. Currently, the lack of proper infrastructure of cold-chain logistics geographically limits distribution and storage of critical biomolecules. The development and commercial implementation of a technology that can enable room temperature stabilization of important biological molecules opens the door for highly sensitive diagnostic devices in the field and in developing regions. Furthermore, stabilization of biologics at room temperature can significantly reduce shipping and storage costs reducing the overall end-user pricing for the drugs. A business strategy based on successful implementation of such a technology can provide a strong case for delivering high quality healthcare anywhere.This I-Corps Project is based on a novel method for creating a highly uniform vitrified (glassy) coating to preserve and protect temperature sensitive biologics including cells and proteins. Formation of a uniformly vitrified environment surrounding the biomolecules in thin film format can arrest degradative chemical reactions and enable storage. The thin-film vitrification technique primarily depends on preferential desiccation of a substrate containing the biomolecules. The technique utilizes a carbohydrate- based formulation which facilitates rapid vitrification at desiccated state. Besides biomolecules, hepatocellular carcinoma (HepG2) cells vitrified at ambient temperatures using this process have been shown to successfully retain their viability following processing.