Production of a Broadly Neutralizing HIV Antibodies

VRC 01是几种非常广泛的NAb中的第一种，已被选择作为人类临床产品生产。 在人体中检测这种NAb可以提供关于这种NAb提供保护免受HIV感染的能力的信息，以及关于设计用于引发类似抗体应答的疫苗是否可能预期提供类似的保护免受HIV感染的信息。 将VRC抗体和疫苗推向市场的下一步是生产大量用于临床试验的bnmAb。 VRC的疫苗生产项目负责cGMP生产、临床前安全性测试和VRC疫苗临床试验的监管提交。 为了迅速满足其临床试验核心的关键项目需求，VRC开发了一个疫苗中试工厂（VPP），用于生产I/II/III期试验的临床材料。 到目前为止，VRC疫苗是由疫苗生产计划通过与疫苗/生物技术行业的公司合作，通过合同开发和生产的，这些合同使工艺和检测开发、GMP生产和产品放行/稳定性测试成为可能。 这种方法使VRC能够迅速应对新出现的公共卫生威胁。

VRC01 is the first of several 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 bnmAb 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.