Production of a Broadly Neutralizing HIV Antibodies

VRC01是几种异常广泛中和的单克隆抗体中的第一个，并被选为人类临床产品。对这种单抗在人体内的测试提供了关于这种单抗对HIV获得性提供保护的能力的信息，以及是否设计一种疫苗来引起类似的抗体反应，可能期望提供类似的对HIV获得性的保护。VPP通过产品稳定性支持和临床试验材料的库存管理，继续支持VRC01在2期疗效研究AMP中的使用。

VRC01 was the first of several exceptionally broadly neutralizing mAbs and was chosen to be produced as a clinical product for human. Testing of this mAb in humans provides information on the ability of this mAb 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 VPP continued to support the use of VRC01 in the Phase 2 efficacy study, AMP, through product stability support and inventory management of the clinical trial material. Vaccine Production Program Laboratory (VPP) at the VRC is responsible for cGMP production and the manufacturing documentation needed for regulatory submission of VRC mAbs for clinical trials. To expeditiously meet the critical program needs of its Clinical Trials Program, the VRC developed a vaccine pilot plant, known as the VCMP (Vaccine Clinical Materials Program) for the manufacture of clinical materials for Phase I/II/III trials. The VPPL expanded the capability of the VCMP for the manufacture of monoclonal antibodies. The VPPL also engages in partnerships and contracts with companies in the vaccine/biotech industry for additional capacity and capability in biologicals manufacturing. The VPPL develops the manufacturing process and analytical methods needed for manufacturing mAbs, transfers the process to the VCMP for cGMP production and product release/stability testing. Such an approach enables the VRC to rapidly respond to emerging public health threats, as evidenced by the VRCs Ebola therapeutic antibody, mAb114, being used under compassionate use protocols and studied under randomized control trial in the 2018/19 Ebola Zaire outbreak in the Democratic Republic of the Congo. A number of mAbs have been developed that have commercial interest (see Products or Services, below). As we proceed down the development pathway the demand for these molecules has increased requiring the development groups to further improve the manufacturing process and test methods to keep up with demand. The VPP has produced 82.5 kg of VRC01 for clinical trial use (Phase 1 studies and the AMP Phase 2 study) and Phase 1 production lots of the mAbs 10E8VLS, N6LS, CAP256LS, VRC01LS, and VRC07-523LS.