Stability Testing of HIV Antibodies and Reagents Used in Downstream Process Purification

下游工艺纯化中使用的 HIV 抗体和试剂的稳定性测试

• 批准号: 10460391
• 负责人: FOUTS TIMOTHY
• 金额: $ 12.54万
• 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: 2021-09-01 至 2024-06-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10460391
• 关键词: Antigens; Clinical Trials; Contractor; Contracts; Databases; Development; Documentation; Equipment and supply inventories; HIV Antibodies; HIV vaccine; HIV-1; Human; In Vitro; Investigational Drugs; Laboratories; Laboratory Animals; National Institute of Allergy and Infectious Disease; Phase; Plant Resins; Preclinical Testing; Preventive vaccine; Process; Production; Proteins; Protocols documentation; Quality Control; Reagent; Reference Standards; Testing; Toxicology; Vaccines; Viral Vector; efficacy study; immunogenicity; neutralizing antibody; 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体临床试验的原型HIV-1预防性疫苗的开发、制造、IND临床前测试和生产监管文件的所有方面。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能够更迅速、更有效地缩小艾滋病毒疫苗的开发和生产差距。活动将是小规模生产，临床前测试和文件，导致新药研究（IND）提交I， II和III期临床测试。活动包括协助产品的识别、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动物的毒理学测试；并利用GMP生产规程生产有前景的产品。此外，承包商还应保持产品的库存，提供质量保证和质量控制，提供适当的法规文件，并开发和管理跟踪产品临床前开发的数据库。