SBIR Phase I: A high-efficiency filter for endotoxin removal

SBIR 第一阶段：去除内毒素的高效过滤器

• 批准号: 2035882
• 负责人: David Howell
• 金额: $ 23.55万
• 依托单位: BONDWELL TECHNOLOGIES LP
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2035882&HistoricalAwards=false
• 关键词: SBIR; Phase; efficiency; filter; endotoxin

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a system to improve pharmaceutical manufacturing and sepsis treatment. A toxic substance known as endotoxin is a common contaminant in many types of therapeutics, and it is the primary cause of batch rejection in pharmaceutical manufacturing. The economic impact of pharmaceutical batch failure due to contamination is high due to loss of product and facility closure for cleaning. The endotoxin removal market within drug manufacturing was valued at $315 million in 2018 and is expected to grow due to the increase in biopharmaceutical products. Additionally, endotoxins are dangerous when they enter patients’ bloodstream and can cause various medical complications, including sepsis. The technology has the potential to remove endotoxins from patients’ bloodstream more effectively than current solutions This project will develop a universal high-efficiency endotoxin removal filter that has the potential to not only improve drug manufacturing but also provide a life-saving treatment for sepsis.This Small Business Innovation Research (SBIR) Phase I project will develop a high-affinity, high-specificity filter for endotoxin removal by using a protein that specifically binds endotoxin and has been shown to remove 99.9% of endotoxin from protein preparations. Traditionally, the use of proteins for product separations cause problems with durability and protein density, stability, and activity. These problems are overcome with unique materials that allow 100% incorporation of active proteins via a stable fusion with substantially increased protein stability. The binding capacity of the materials for endotoxin similar to current solutions (5,000,000 EU/mL) would be considered successful, although the binding capacity is expected to greatly exceed the current standard. Current solutions are compatible with only specific types of therapeutics. A prototype filter will be evaluated for endotoxin separation and protein recovery for three protein therapeutics. An 80% recovery of each therapeutic is expected, with simultaneous removal of 5,000,000 EU/mL of endotoxin. These tests will prove the technical feasibility of the prototype filter by showing the materials have a significantly higher binding capacity for endotoxin than current methods and that they are compatible with multiple types of therapeutics.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是开发一种系统来改进药品制造和脓毒症治疗，一种称为内毒素的有毒物质是许多类型的治疗中的常见污染物，并且它是一种有毒物质。药品生产中批次废品的主要原因是由于产品损失和清洁设施关闭造成的药品批次失败的经济影响很高。 2018 年，由于生物制药产品的增加，预计该技术将增长。此外，内毒素进入血液时是危险的，可能导致各种医疗并发症，包括败血症。该技术有可能比现有技术更有效地清除患者血液中的内毒素。该项目将开发一种通用的高效内毒素去除过滤器，不仅有可能改善药物生产，还可以为脓毒症提供挽救生命的治疗方法。该小型企业创新研究 (SBIR) 第一阶段该项目将开发一种高亲和力、高特异性的过滤器，通过使用特异性结合内毒素的蛋白质来去除内毒素，并已被证明可以去除蛋白质制剂中 99.9% 的内毒素。传统上，使用蛋白质进行产品分离会导致耐久性问题。这些问题可以通过独特的材料来克服，这些材料可以通过稳定的融合来 100% 地掺入活性蛋白，并且该材料对内毒素的结合能力与目前的相似。解决方案（5,000,000 EU/mL）将被认为是成功的，尽管目前的解决方案的结合能力预计将大大超过当前的标准，但原型过滤器将用于三种内毒素分离和蛋白质回收的评估。预计每种治疗剂的回收率为 80%，同时去除 5,000,000 EU/mL 的内毒素。这些测试将通过显示材料具有显着更高的能力来证明原型过滤器的技术可行性。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。