cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine

基于纳米颗粒的 HIV 包膜疫苗的 cGMP 制造、填充、释放和稳定性测试

• 批准号: 10789830
• 负责人: TIMOTHY FOUTS
• 金额: $ 161.94万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-29 至 2025-01-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10789830
• 关键词: Acceleration; Antigens; Clinical Trials; Contractor; Contracts; Databases; Development; Documentation; Engineering; Equipment and supply inventories; Good Manufacturing Process; HIV envelope protein; HIV vaccine; HIV-1; Human; In Vitro; Investigational Drugs; Label; Laboratories; Laboratory Animals; National Institute of Allergy and Infectious Disease; Phase; Preclinical Testing; Preventive vaccine; Production; Proteins; Protocols documentation; Quality Control; Testing; Toxicology; Vaccines; Viral Vector; efficacy study; immunogenicity; manufacture; manufacturing run; nanoparticle; plasmid DNA; preclinical development; product development; prototype; quality assurance; research clinical testing; stability testing

The purpose of this contract is to provide all aspects of the development, manufacture, IND enabling preclinical testing, and the production of regulatory documents for prototype HIV-1 prophylactic vaccines for human clinical trials. This includes all types of HIV-1 vaccines including DNA plasmids, viral vectors, and protein antigens. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps for HIV vaccines. Activities would be for the small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Activities include assisting in the identification, testing, and development of products; participation in and managing preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products.

该合同的目的是提供用于人类临床试验的原型HIV-1预防性疫苗的开发、制造、IND使能临床前测试和监管文件的制作的所有方面。这包括所有类型的HIV-1疫苗，包括DNA质粒、病毒载体和蛋白质抗原。这些能力将使NIAID能够更快、更有效地缩小艾滋病毒疫苗的开发和生产差距。活动将用于小规模生产、临床前试验和文件编制，以提交研究性新药（IND）进行I期、II期和III期临床试验。活动包括协助产品的鉴定，测试和开发;参与和管理临床前测试，包括体外实验室测试，免疫原性测试，功效研究和使用实验室动物的毒理学测试;并利用GMP生产协议生产有前途的产品。此外，承包商还应维护产品库存，提供质量保证和质量控制，提供适当的监管文件，并开发和管理跟踪产品临床前开发的数据库。