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 通过为正在研究的RMRCE调查人员提供区域资源来开发产品 针对NIAID类别A-C优先病原体或免费的治疗和疫苗技术 平台。该核心解决了一个关键障碍，该障碍可以防止产品翻译领域的进展 提供特定的优质实验室实践（GLP），GLP和当前良好的制造实践（CGMP） 跨越基本的臭名昭著的“死亡谷”的桥梁的服务，资源和培训 研究产品商业化。 PDM核心将通过三个特定的 目的：1）从RMRCE产品管道中转换生物产品； 2）协助机构建立 临床前研究的GLP合规性，3）为VITRO药物易感性测试计划 治疗候选人。可用的支持将涵盖三个维度中的每个维度（安全，医疗 效用和工业化）在食品和药物描述的翻译关键路径中确定 管理（FDA）。具体而言，服务包括：产品开发计划和监视，单元格 基于测定的开发，过程优化和扩展，稳定性测试，受控文档，Invitro 药物测试，参考批量制备，GLP临床前批次和CGMP临床生产，质量 对GLP和CGMP项目的监督，IND应用指导以及各种级别的培训。最终， PDM核心的功能是通过提供缺失的链接来简化产品开发过程。 提供PDM核心功能，设施，资源和专业知识将加强产品配置文件， 利用行业或政府利益支持晚期发展。结果更多 有效，高效，及时且成本较低的产品进入公共部门；对我们所有人的好处。 核心D将支持所有三个RMRCE综合研究重点，佐剂和佐剂和 疫苗（IRF 1），细菌疗法（IRF 2）和病毒疗法（IRF 3）。它的资源将是 由RP 1.2、1.4、1.8、2.3和3.6以及CD 1和2.1使用。