Product Development and Manufacturing Core

产品开发和制造核心

• 批准号: 8070333
• 负责人: Becky L Rivoire PhD
• 金额: $ 31.87万
• 依托单位: COLORADO STATE 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/8070333
• 关键词: Address; Area; Basic Science; Biological Products; Categories; Cells; Cessation of life; Clinic; Critical Pathways; Data; Development; Development Plans; Dimensions; Documentation; Educational Status; Emerging Communicable Diseases; Failure; Government; Human; In Vitro; Industrialization; Industry; Institution; Intervention; Licensing; Link; Medical; Monitor; National Institute of Allergy and Infectious Disease; Outcome; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Predisposition; Preparation; Process; Public Sector; Research; Research Personnel; Resources; Risk; Safety; Services; Technology; Testing; Therapeutic; Training; Translating; Translations; United States Food and Drug Administration; Vaccine Adjuvant; Viral; Work; assay development; base; clinical lot; commercialization; cost; drug testing; good laboratory practice; immunoregulation; interest; lot production; pathogen; pre-clinical; preclinical study; prevent; process optimization; product development; programs; safety testing; scale up; stability testing; therapeutic vaccine

The long-term objective for Core D, Product Development and Manufacturing (RDM) Core, is to facilitate the development of products by providing a regional resource for RMRCE investigators who are working on therapeutic, and vaccine technologies against the NIAID Category A-C Priority Pathogens or complimentary platforms. This Core addresses a critical barrier that prevents progress in the area of product translation by offering specific pre-good laboratory practice (GLP), GLP, and current good manufacturing practice (cGMP) services, resources, and training that act as a bridge over the notorious "Valley of Death" spanning basic research to product commercialization. The PDM Core will accomplish this objective with three specific aims: 1) translate biological products from the RMRCE Product Pipeline; 2) assist institutions in establishing GLP compliance for preclinical studies, and 3) develop an in-vitro drug susceptibility testing program for therapeutic candidates. Available support will encompass each of the three dimensions (safety, medical utility, and industrialization) identified in the Translational Critical Path described by the Food and Drug Administration (FDA). Specifically, services include: product development planning and monitoring, cell based assay development, process optimization and scale-up, stability testing, controlled documentation, invitro drug testing, reference lot preparation, GLP preclinical lot and cGMP clinical lot production, quality oversight for GLP and cGMP projects, IND application guidance, and various levels of training. Ultimately, the function of the PDM Core is to streamline the product development process by providing the missing link. Provision of PDM Core capabilities, facilities, resources and expertise will strengthen product profiles, leveraging industry or government interest to support late phase development. The outcome is a more effective, efficient, timely and less costly product moving into the public sector; a benefit to us all. Core D will support all three of the RMRCE Integrated Research Foci on Immunomodulation, Adjuvants and Vaccines (IRF 1), Bacterial Therapeutics (IRF 2), and Viral Therapeutics (IRF 3). Its resources will be utilized by RP 1.2, 1.4, 1.8, 2.3 and 3.6 as well as by CD 1 and 2.1.

核心D（产品开发和制造（RDM）核心）的长期目标是促进 通过为从事以下工作的RMRCE研究人员提供区域资源来开发产品： 针对NIAID A-C类优先病原体的治疗和疫苗技术，或 平台该核心解决了阻碍产品翻译领域取得进展的关键障碍， 提供特定的药物非临床研究质量管理规范（GLP）、GLP和现行药品生产质量管理规范（cGMP） 服务、资源和培训，作为跨越臭名昭著的“死亡之谷”的桥梁， 从研究到产品商业化。PDM核心将通过以下三个具体方面来实现这一目标： 目的：1）从RMRCE产品管道翻译生物产品; 2）协助机构建立 临床前研究的GLP合规性，以及3）制定体外药物敏感性试验计划， 治疗候选人。可提供的支持将包括三个方面（安全、医疗 实用性和工业化）中确定的转化关键路径描述的食品和药品 管理局（FDA）。具体而言，服务包括：产品开发规划和监控， 基于分析开发、工艺优化和扩大规模、稳定性测试、受控文件、体外 药物检测、参比批次制备、GLP临床前批次和cGMP临床批次生产、质量 监督GLP和cGMP项目、IND申请指南和各种级别的培训。最后， PDM核心的功能是通过提供缺失的环节来简化产品开发过程。 提供PDM核心能力、设施、资源和专业知识将加强产品概况， 利用行业或政府的利益来支持后期开发。结果是一个更 有效、高效、及时和成本较低的产品进入公共部门;对我们所有人都有好处。 核心D将支持所有三个RMRCE综合研究重点免疫调节，佐剂和 疫苗（IRF 1）、细菌治疗（IRF 2）和病毒治疗（IRF 3）。其资源将 由RP 1.2、1.4、1.8、2.3和3.6以及CD 1和2.1使用。