Nanofabrication Core Facility

纳米加工核心设施

• 批准号: 8381590
• 负责人: Timothy Patrick Coleman
• 金额: $ 13.13万
• 依托单位: NORTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8381590
• 关键词: Chemistry; Core Facility; Dendrimers; Engineering; Ensure; Environment; Environment Design; Funding; Image; Liposomes; Malignant Neoplasms; Manufactured Materials; Manufacturer Name; Medical; Micelles; Modeling; Monitor; Pathway interactions; Process; Production; Qualifying; Resources; Technology; Testing; Therapeutic; base; design; flexibility; innovation; manufacturing facility; manufacturing process; nanofabrication; nanomedicine; nanoparticle; physical property

Nanofabrication Core Facility Nemucore Medical Innovations (NMI) is establishing a first in the nation cGLP nanomedicine manufacturing facility compliant with Quality by Design (QbD) principles. NMI activities will focus on converting consortium nanomedicines into target product profiles and defining the critical quality attributes required to manufacture material at a GLP scale. Our efforts will prove the NMI facility can become a national resource to advance the promise of nanomedicine. Fundamentally, NMI will be creating an environment where lab scale fabrication and chemistry will be engineered into repeatable, in control processes: a capability completely absent today. QbD allows a common manufacturing footprint to become a highly flexible process driven environment that is capable of handling multiple product pathways. This concept of flexibility is important as nanomedicines have taken on many different physical properties but they do have similarities in how they are assembled and prepared for investigational purposes. Additionally, the QdD model is also adaptable to multifunctional nanomedicines, with potential to target, image, and deliver therapeutic payload from a single platform. NMI's plan is use the core funding develop a QbD environment which can manufacturer multifunctional: liposomes, polymeric nanoparticles, liposomes, polymeric micelles, polymeric nanoparticles, and dendrimers. NMI's activities indicate how NMI will commission, calibrate, qualify, and validate a flexible manufacturing environment for the pilot scale GLP production ofthe consortiums nanomedicines.

纳米加工核心设施 Nemucore Medical Innovations (NMI) 正在建立全国首个符合质量源于设计 (QbD) 原则的 cGLP 纳米药物制造工厂。 NMI 的活动将侧重于将联盟纳米药物转化为目标产品概况，并定义以 GLP 规模制造材料所需的关键质量属性。我们的努力将证明 NMI 设施可以成为推进纳米医学前景的国家资源。 从根本上说，NMI 将创造一个实验室规模制造和化学的环境 设计成可重复的控制流程：如今完全不具备这种能力。 QbD 允许 共同的制造足迹成为一个高度灵活的流程驱动环境，能够处理多种产品路径。这种灵活性的概念很重要，因为纳米药物具有许多不同的物理特性，但它们在用于研究目的的组装和制备方式方面确实有相似之处。此外，QdD 模型还适用于多功能纳米药物，具有从单一平台进行靶向、成像和递送治疗有效负载的潜力。 NMI 的计划是利用核心资金开发 QbD 环境，该环境可以制造多功能：脂质体、聚合物纳米颗粒、脂质体、聚合物胶束、聚合物纳米颗粒和树枝状聚合物。 NMI 的活动表明 NMI 将如何调试、校准、鉴定和验证灵活的制造环境 联盟纳米药物的中试规模 GLP 生产。