Production of a Broadly Neutralizing HIV Antibodies

VRC01是几种特别广泛的nab中的第一个，已被选为人类临床产品。在人体中对这种NAb进行测试，可以提供有关这种NAb提供防止艾滋病毒获得的保护能力的信息，以及设计用于引起类似抗体反应的疫苗是否有望提供类似的防止艾滋病毒获得的保护。

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. A number of mAbs have been developed that may have commercial interest N6LS, VRC07 and 10E8 are examples. The trimer vaccines and peptide conjugates also hold promise as potential products. As we proceed down the development pathway the demand for these molecules has increased requiring the develop groups to further improves the process and test methods to keep up with demand.