SBIR Phase II: Microglassification: Dehydration Process for Protein Preservation

SBIR 第二阶段：微玻璃化：蛋白质保存的脱水过程

• 批准号: 0848968
• 负责人: Deborah Bitterfield
• 金额: --
• 依托单位: Southeast TechInventures
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0848968&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Microglassification; Dehydration

This Small Business Innovation Research (SBIR) Phase II project will advance the recent discovery of an ambient temperature dehydration method "Microglassification" that is designed to more efficiently stabilize biomolecules for preservation. Lyophilization is the current process of choice, but it has major disadvantages including high capital cost of equipment, high energy costs, and long process time. Furthermore, with the advent of new protein therapeutics, diagnostics, vaccines, such expensive and environment-sensitive biomolecules can be irreversibly impacted due to the stresses of the freezing and the drying process and may never reach the market due to insufficient stability or even degradation that makes them antigenic and toxic in the body. Incorporation of Microglassification to produce a dry formulation of a biomolecule leads to following benefits: reduction in operation costs, production time savings, increased yield and purity, increased long-term stability, and reduced capital equipment costs.The broader impacts of this research are not limited to broader temperature tolerances for the microglassified products facilitating storage and transport of sensitive biologics throughout the US, and also to developing countries. But also this research furthers the fundamental understanding of water removal from a protein (how molecular layers of water of hydration influence protein activity), the structural changes that might occur in the protein, and the protein interactions with its surrounding environment. It is expected that Microglassification will provide the needed stability to enable a biotechnological advance to reach the market, and, more importantly, reach the patient.

这个小企业创新研究（SBIR）第二阶段项目将推进最近发现的一种环境温度脱水方法“微玻璃化”，该方法旨在更有效地稳定生物分子以进行保存。冻干是当前的选择方法，但其具有主要缺点，包括设备的高资本成本、高能量成本和长处理时间。此外，随着新的蛋白质治疗剂、诊断剂、疫苗的出现，这种昂贵的和环境敏感的生物分子可能由于冷冻和干燥过程的应力而受到不可逆的影响，并且可能由于稳定性不足或甚至降解而永远不会进入市场，这使得它们在体内具有抗原性和毒性。引入微玻璃化以产生生物分子的干燥制剂导致以下益处：降低操作成本，节省生产时间，提高产率和纯度，提高长期稳定性，降低资本设备成本。这项研究的更广泛影响不仅限于微玻璃化产品的更广泛温度耐受性，促进敏感生物制剂在美国各地的储存和运输，以及发展中国家。但这项研究也进一步从蛋白质中去除水的基本理解（水合水的分子层如何影响蛋白质活性），蛋白质中可能发生的结构变化以及蛋白质与周围环境的相互作用。预计微玻璃化将提供所需的稳定性，使生物技术的进步能够进入市场，更重要的是，到达患者。