High Throughput Manufacturing of Monodispersed Nanoparticles for Biomedicine

用于生物医学的单分散纳米颗粒的高通量制造

基本信息

批准号：
8833373
负责人：
Tania Betancourt
金额：
$ 15万
依托单位：
CHEMTOR, LP
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-30 至 2015-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8833373
关键词：
Acrylamides Adoption Area Biological Availability Biomedical Engineering Biomedical Research Biosensor Biotechnology Businesses Chemical Engineering Computer software Contrast Media Data Development Drug Delivery Systems Drug Formulations Electron Microscopy Emulsions Engineering Ethylene Glycols Evaluation Fiber Gel Glycolates Human Resources Hydrogels Industry Laboratories Letters Marketing Mediating Medical Methods Modeling Monitor Morphology Nanotechnology Particle Size Pharmaceutical Preparations Pharmacologic Substance Phase Plants Polymers Population Precipitation Preparation Principal Investigator Process Production Reproducibility Research Route Safety Secure Small Business Technology Transfer Research Solid Suspension substance Suspensions System Technology Technology Transfer Tennessee Testing Texas Therapeutic Thick Work Writing base bioimaging clinical practice commercialization cost design design and construction ethylene glycol improved light scattering manufacturing process meetings method development nanocomposite nanometer nanoparticle novel novel diagnostics operation particle photonics poly-N-isopropylacrylamide polymerization process optimization prototype public health relevance research and development research study scale up statistics success theranostics

项目摘要

DESCRIPTION (provided by applicant): This Phase I Small Business Technology Transfer (STTR) project focuses on the development of a new platform manufacturing process for large-scale preparation of monodispersed polymeric nanoparticles (NPs) suitable for biomedical applications through the use of a large-scale fiber fluidic system. Although laboratory processes for reproducible synthesis of polymeric particles through emulsion and nanoprecipitation methods have matured, the development of suitable methods for synthesis of such monodispersed NPs in the scales required for commercialization has not been achieved. The proposed system aims to meet this need by providing a versatile, rugged and easily scalable process that can be used for continuous manufacture of polymeric NPs in a small footprint. After seeing our preliminary data, David Nowotnik, Senior Vice President Research and Development at Access Pharmaceuticals wrote: "A process that could be used in the lab to make monodisperse nanoparticles for medical applications would be useful. One that could easily be scaled to pilot plant and manufacturing would be extremely useful to Access and the industry...this project has significant potential for the development of a new value added nanoparticle manufacturing process for industry." The main objectives of the Phase I project will be to: (1) build a Phase I fiber fluidic system prototype, (2) develop methods for the preparation of a variety of polymeric NPs relevant to biomedical applications utilizing this prototype, (3) optimize process parameters to improve throughput and control over NP size and monodispersity, and (4) prepare for Phase II by identifying parameters where optimization will be required, performing thorough market analysis, and establishing partnership with potential customers. To achieve these aims, the team will utilize the proposed fiber fluidic system for the preparation of hydrophobic, core-shell, and hydrogel-type polymeric NPs via nanoprecipitation and emulsion polymerization methods utilizing a number of monomeric and polymeric precursors including acrylamide, N-isopropyl acrylamide, poly(lactic- co-glycolic acid), and poly(lactic acid)-b-poly(ethylene glycol). A select number of formulations will then be optimized to achieve maximal production rates while maintaining optimal control over NP size and monodispersity. NP formulations will be characterized via dynamic light scattering and electron microscopy. Completion of Phase I aims will demonstrate the versatility and benefits of the proposed manufacturing technology in terms of throughput and process control compared to batch processes, while pointing out the main aspects of process optimization required for successful commercialization. Successful completion of this project will result in a low-cost, highly throughput, and commercially viable process for manufacture of particles with applications in biotechnology, biomedical research, and pharmaceutical fields as precursors for nanocomposites, coatings, porogens in biosepartion gels, drug delivery systems, and contrast agents. We will work with Access and other potential customers to identify optimal methods for adoption of this manufacturing technology into existing and planned facilities.

描述（由申请人提供）：本I期小型企业技术转移（STTR）项目着重于开发新的平台制造过程，用于大规模准备单分散的聚合物纳米粒子（NPS），适用于使用大型纤维流体系统，适用于生物医学应用。尽管通过乳液和纳米沉淀方法可重复合成聚合物颗粒的实验室过程已经成熟，但尚未实现合理的合成这种单分散NPS在商业化所需的尺度中的合成方法的发展。拟议的系统旨在通过提供一种多功能，坚固且易于扩展的过程来满足这一需求，该过程可用于在少量足迹中连续生产聚合物NP。在看到了我们的初步数据之后，Access Pharmaceuticals高级副总裁研发大卫·诺特尼克（David Nowotnik）写道：“一个可以在实验室中使用的过程来制造用于医疗应用的单分散纳米粒子。一个可以很容易地扩展到PILOT工厂和制造业的工业和行业非常有用，并且该项目可用于访问该项目的重要工程，以便为开发一个新价值的工业而进行了巨大的潜力。第一阶段项目的主要目标是：（1）建立一个I期纤维流动系统原型，（2）开发用于制备与生物医学应用相关的各种聚合物NP的方法分析并与潜在客户建立伙伴关系。 To achieve these aims, the team will utilize the proposed fiber fluidic system for the preparation of hydrophobic, core-shell, and hydrogel-type polymeric NPs via nanoprecipitation and emulsion polymerization methods utilizing a number of monomeric and polymeric precursors including acrylamide, N-isopropyl acrylamide, poly(lactic- co-glycolic acid), and poly(lactic酸）-b-Poly（乙二醇）。然后，将优化一定数量的配方，以达到最大生产率，同时保持对NP大小和单分散性的最佳控制。 NP配方将通过动态光散射和电子显微镜进行表征。 I阶段目标的完成将证明与批处理过程相比，在吞吐量和过程控制方面，提出的制造技术的多功能性和好处，同时指出成功商业化所需的过程优化的主要方面。该项目的成功完成将导致生物技术，生物医学研究和药物领域应用颗粒的生产较低，高吞吐量且在商业上可行的过程，作为纳米复合材料，涂料，Porogens，Porogens，Porogens，Porogens，Porogens in Biosepartion凝胶，药物递送系统和形成近似染色体的前体。我们将与Access和其他潜在客户合作，以确定采用该制造技术的最佳方法，以投入现有和计划中的设施。