SBIR Phase II: Removing the Purification Bottleneck in Biopharmaceutical Production

这个小企业创新研究（SBIR）二期项目的更广泛影响是消除生物制药生产中的纯化瓶颈。蛋白质工程使新的实验能够更好地了解疾病的分子基础，并有助于发现新的生物制药。然而，从成千上万的其他蛋白质中低成本地纯化感兴趣的蛋白质仍然是一个挑战。获得廉价的蛋白质用于研究将加速药物发现，估计节省10倍。拟议的项目将在规模上优化发展。拟议的项目将在各种操作规模上推进一套蛋白质纯化解决方案的翻译。拟议的项目将优化一个研究规模的重组蛋白纯化试剂盒，估计用于目前研究中80%的纯化。将为剩余的20%开发高产量和高纯度的专用试剂盒。用于在纯化后从感兴趣的蛋白质上去除亲和标签的酶将被大规模开发。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to remove the purification bottleneck in biopharmaceutical production. Protein engineering has enabled the new experiments to better understand the molecular basis of disease and to aid in the discovery of new biopharmaceuticals. However, low-cost purification of the protein of interest from thousands of other proteins remains a challenge. Access to inexpensive proteins for study will accelerate drug discovery with an estimated 10x savings. The proposed project will optimize development at scale. The proposed project will advance the translation of a suite of protein purification solutions at various operational scales. The proposed project will optimize a research-scale kit for recombinant protein purification for an estimated eighty percent of the purifications performed in research today. Specialized kits for high yield and purity will be developed for the remaining twenty percent. Enzymes used to remove an affinity tag from the protein of interest after it has been purified will be developed at scale.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.