SBIR Phase II: Efficient and Scalable Production of Functionalized Electrospun Nanofiber Felts of Regenerated Cellulose with Superior Capacity and Throughput for Bioseparations

这一小型企业创新研究(SBIR)第二阶段项目从纳米纤维分离，有限责任公司将建立一种创新的类型的生物分离介质使用电纺纳米纤维毡/垫的再生纤维具有高比表面积作为蛋白质吸附配体的支持。与竞争产品(如填充树脂珠或超细纤维吸附膜)相比，这些纳米纤维膜/毡将大大提高产量(即更短的处理时间)，减少产生的废物量，并减少提纯高价值生物制药产品所需的介质体积(即更低的成本和更小的操作占地面积)。通过开发功能化纳米纤维毡的制造工艺，SBIR第一阶段项目成功完成，并证明了与商业产品相比的优异性能。该SBIR第二阶段项目将侧重于进一步优化用于生物分离的纳米纤维吸附剂生产过程中使用的配方。这将包括第二阶段预计的商业制造工作所需的两个扩大步骤(纳米纤维毡生产、表面功能化和模块开发)。关键的技术改进，包括更大的产品稳定性和更广泛的生物分离所需的功能配体，将继续对纳米纤维毡/垫进行改进。这个项目的更广泛的影响/商业潜力远远超出了生物隔离。由于再生纤维素表面功能化电纺纳米纤维的诸多优点，这种新型吸附材料具有巨大的商业潜力。客户将来自生物制药行业的公司，以及生物分离吸附介质的老牌制造商。此外，与纳米纤维吸附介质相关的基本原理将产生广泛的影响，包括水净化行业以及血液制品和/或血液净化行业的更有效的分离过程。通过这项创新工作获得的优势将导致许多部门采用更高效的分离技术，包括更快的流程、更低的能源消耗、更低的材料需求和更少的废物产生。除了更广泛的科学影响，纳米纤维分离，有限责任公司致力于创造就业机会和培训高技术员工，为他们提供先进功能材料(包括纳米级材料)和/或生物技术等跨学科领域的专业知识。

This Small Business Innovation Research (SBIR) Phase II project from Nanofiber Separations, LLC will establish an innovative type of bioseparation media utilizing electrospun nanofiber felts/mats of regenerated cellulose with high specific surface area as the support for protein adsorption ligands. Compared to competitive products (e.g., packed resin beads or microfiber adsorption membranes), these nanofiber membranes/felts will provide greatly enhanced throughput (i.e., shorter processing times), reduce the amount of waste generated, and decrease the volume of media required (i.e., lower costs and smaller operating footprints) for purification of high-value biopharmaceutical products. The SBIR Phase I project was completed successfully by developing a manufacturing process for the functionalized nanofiber felts and proving superior performance compared to commercial products. This SBIR Phase II project will focus on further optimization of the formulations used during production of the nanofiber adsorbents for bioseparations. This will include two scale-up steps needed for the commercial manufacturing effort anticipated during the Phase II timeline (nanofiber felt production, surface functionalization, and module development). Key technical improvements, including greater product stability and a broader array of functional ligands needed in bioseparations, will continue to be made to the nanofiber felts/mats. The broader impact/commercial potential of this project goes well beyond bioseparations. Due to the many advantages of the surface-functionalized electrospun nanofibers made from regenerated cellulose, this innovative adsorption material has tremendous commercial potential. Customers will come from companies within the biopharmaceutical industry, as well as from the established manufacturers of bioseparations adsorption media. Additionally, the underlying fundamentals associated with nanofiber adsorption media will have a wide range of implications, including more efficient separation processes in the water purification industry and the blood products and/or blood purification industries. The advantages achieved through this innovative work will lead to more efficient separation technologies across many sectors and include faster processes, reduced energy consumption, lower materials requirements, and less waste generation. In addition to the broader scientific impacts, Nanofiber Separations, LLC is committed to creating jobs and to training highly technical staff members, providing them with expertise in the interdisciplinary fields of advanced functional materials (including nano-scaled materials) and/or biotechnology.