VACCINE PRODUCTION FACILITY

疫苗生产设施

• 批准号: 6158935
• 负责人: Donna M Ambrosino
• 金额: --
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6158935
• 关键词: biomedical facility; drug design /synthesis /production; vaccine development; vaccines

The objective of this project is to provide a facility for the production and safety testing of vaccine preparations intended for evaluation in the Vaccine, Treatment and Evaluation Units (VTEUs) of the Division of Microbiology and Infectious Diseases (DMID). The facility will also serve as a repository for specimens generated during DMID-supported Phase I, II, and III clinical trials. Specifically- this facility will accelerate the development of new and improved vaccines of public health importance. The work in this contract encompasses the development and pilot lot production, and related studies, of vaccines appropriate for human clinical trials. With an ever-growing number of NIAID supported clinical vaccine evaluations there is also a growing need for a central facility to systematically store, transport and track and increasing number of clinical specimens that are generated during DMID-supported clinical trials. The capacity to develop and produce a wide range of such candidates will enhance the ability of DMID to meet its expanding needs and better fulfill its mission by promoting and supporting preclinical and clinical research on vaccines that will improve the health of the public. Therefore- this contract will provide the capability for all aspects of development and pilot lot production, including safety testing, of a broad range of vaccine candidates (including viral, bacterial, parasitic and fungal preparations and subtractions consisting of polysaccharides, nucleic acids, lipoproteins, and/or synthetic or purified proteins (either linear or variations of branched multiple antigen preparations) intended for evaluation in humans as experimental vaccines.

该项目的目的是为生产提供设施 和旨在评估疫苗制剂的安全测试 疫苗，治疗和评估单位（VTEU） 微生物学和传染病（DMID）。该设施也将服务 作为在DMID支持I期中生成的标本的存储库， II和III临床试验。具体 - 此设施将加速 开发新的和改善公共卫生重要性的疫苗。 该合同中的工作涵盖了开发和飞行员地段 适合人类的疫苗的生产和相关研究 临床试验。具有不断增长的NIAID支持的临床 疫苗评估也越来越需要中央设施 系统地存储，运输和跟踪并增加数量 在DMID支持的临床期间产生的临床标本 试验。 发展和生产各种此类候选人的能力将 增强DMID满足其不断扩展的需求和更好的能力 通过促进和支持临床前和临床来实现其任务 研究将改善公众健康的疫苗。 因此 - 该合同将为所有方面的各个方面提供能力 开发和试点批次生产，包括安全测试 广泛的疫苗候选物（包括病毒，细菌，寄生虫 以及由多糖组成的真菌制剂和减法 核酸，脂蛋白和/或合成或纯化蛋白 （分支多个抗原制剂的线性或变化） 旨在在人类中作为实验疫苗进行评估。