Production of a Broadly Neutralizing HIV Antibody (VRC01)

广泛中和 HIV 抗体 (VRC01) 的生产

• 批准号: 8336681
• 负责人: Richard Schwartz
• 金额: $ 175.54万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 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/8336681
• 关键词: Antibodies; Antibody Formation; Biotechnology; Clinical; Clinical Trials; Collaborations; Contracts; HIV; HIV Antibodies; Human; Industry; Marketing; Phase; Plants; Process; Production; Public Health; Relative (related person); Testing; Therapeutic; Vaccine Clinical Trial; Vaccine Design; Vaccine Production; Vaccines; assay development; cGMP production; clinical application; clinical material; meetings; neutralizing antibody; pre-clinical; programs; safety testing; stability testing; vaccine development

VRC01 is one of these severak exceptionally broad NAbs and has been chosen to be produced as a clinical product for human. Testing of this NAb in humans can provide information relative to the ability of this NAb to provide protection from HIV acquisition and as to whether a vaccine designed to elicit a similar antibody response might be expected to provide similar protection from acquisition from HIV. The next step in bringing the VRC antibody and vaccines to market involves producing large quantities of the MAb (NAb) for use in clinical trials. Vaccine Production Program at the VRC is responsible for cGMP production, pre-clinical safety testing and regulatory submission of VRC vaccines for clinical trials. To expeditiously meet the critical program needs of its Clinical Trials Core, the VRC developed a Vaccine Pilot Plant (VPP) for the manufacture of clinical materials for Phase I/II/III trials. To date, VRC vaccines have been developed and manufactured by the Vaccine Production Program through collaborations with companies in the vaccine/biotechnology industry, via contracts that enable process and assay development, GMP manufacturing and product release/stability testing. Such an approach enables the VRC to rapidly respond to emerging public health threats.

VRC01是这些Severak非常广泛的NAB之一，已被选为人类的临床产品。 在人类中对这种NAB的测试可以提供有关该NAB提供免受HIV获取能力的能力以及旨在引起类似抗体反应的疫苗是否提供类似保护的疫苗，从而提供相似的保护，从而提供相似的信息。 将VRC抗体和疫苗推向市场的下一步是生产大量的MAB（NAB）用于临床试验。 VRC的疫苗生产计划负责CGMP的生产，临床前安全测试和VRC疫苗的调节性提交用于临床试验。 为了迅速满足其临床试验核心的关键计划需求，VRC开发了一种疫苗试验厂（VPP），用于生产I/II/III期试验的临床材料。 迄今为止，疫苗生产计划通过与疫苗/生物技术行业的公司合作开发和制造了VRC疫苗，通过合同，通过合同，可以使过程开发，GMP制造和产品释放/稳定性测试。 这种方法使VRC能够快速应对新兴的公共卫生威胁。