SBIR Phase II: Asymmetric Block Copolymer Membranes for Ultrafiltration

这一小型企业创新研究(SBIR)第二阶段项目的广泛影响/商业潜力解决了制造蛋白质疗法或生物制品的高成本问题。生物制剂是一种越来越多的治疗性药物，可以治疗从类风湿性关节炎到溃疡性结肠炎再到阿尔茨海默氏症等一系列疾病。不幸的是，生产这些高效的治疗药物极其昂贵，大部分成本来自于从复杂混合物中提纯目标蛋白。这一二期项目旨在开发一种新的过滤设备，使生物制剂的提纯速度更快、成本更低。过滤介质将提高总产量，从而缓解提纯过程中的瓶颈步骤。除了降低制造成本外，快速净化还提高了生产线的整体产能。这种高通量过滤设备旨在无缝集成到现有的纯化模块中，使最终用户能够轻松地提高生产效率。该SBIR第二阶段项目旨在显著提高用于蛋白质分离的超滤膜的性能。目前，现有的超滤膜要么通量低得令人望而却步，要么孔径过大，限制了它们在分离过程中的效率。该项目利用一种独特的聚合物材料，即嵌段共聚物，制造克服了以前结构限制的膜。也就是说，嵌段共聚物膜具有非常高的通量和非常均匀的孔径。这些重要的特征是由于嵌段共聚物独特的自组装能力，可以自组装成具有与蛋白质分离相关的长度尺度的周期性、有序结构。采用嵌段共聚自组装和非溶剂诱导相分离相结合的方法，可以以可伸缩的方式制备具有目标孔径的膜。该项目的研究目标是增加支撑嵌段共聚材料的孔隙率，将嵌段共聚物膜附着到织物背衬上，评估组装后的膜片的性能，并将片材封装到设备配置中。完成这些研究目标将产生一种机械坚固、易于实现的膜材料，可以将蛋白质过滤速度提高3-10倍。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the high costs of manufacturing protein therapeutics, or biologics. Biologics are a growing category of therapeutic that can treat a range of diseases from rheumatoid arthritis to ulcerative colitis to Alzheimer's. Unfortunately, producing these highly effective therapeutics is extremely expensive, with most of the cost stemming from the purification of the target protein from a complex mixture. This Phase II project aims to develop a new filter device that makes purifying biologics faster and cheaper. The filter media will increase overall throughput, thereby easing bottleneck steps in the purification process. In addition to decreased manufacturing costs, the expedited purification also increases the overall capacity of the manufacturing line. This high throughput filter device is designed to fit seamlessly into existing purification modules, making it easy for end users to increase production efficiencies.This SBIR Phase II project aims to dramatically improve the performance of ultrafiltration membranes used in protein separations. Currently existing ultrafiltration membranes suffer from either prohibitively low throughputs or broad pore sizes, limiting their efficacy in separation processes. This project takes advantage of a unique class of polymeric materials, known as block copolymers, to make membranes that overcome the previous structural limitations. Namely, the block copolymer membranes have very high throughputs and very uniform pore sizes. These important features are possible due to the distinct ability of block copolymers to self-assembly into periodic, ordered structures with length scales relevant for protein separations. Using a combination of block copolymer self-assembly and non-solvent induced phase separation, membranes with targeted pore sizes can be made in scalable way. The research objectives for this project are to increase the porosity of the supporting block copolymer material, attach the block copolymer membrane to a fabric backing, evaluate the performance of assembled membrane sheet stock, and package the sheet stock into a device configuration. Accomplishing these research objectives will result in a mechanically robust, easy to implement membrane material that can increase the rate of protein filtration by 3-10 fold.