Production of a Broadly Neutralizing HIV Antibodies

VRC01是几种异常广泛的NAB中的第一种，已被选为人类临床产品。在人类身上测试这种NAB可以提供有关这种NAB提供预防艾滋病毒感染的能力的信息，以及旨在引起类似抗体反应的疫苗是否有望提供类似的预防艾滋病毒感染的保护。 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的疫苗生产计划负责生产cGMP、临床前安全性测试和VRC疫苗的监管提交以进行临床试验。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疫苗已经由疫苗生产计划通过与疫苗/生物技术行业的公司合作，通过合同实现工艺和化验开发、GMP制造和产品释放/稳定性测试来开发和制造。这种方法使VRC能够对新出现的公共卫生威胁做出快速反应。已经开发了许多可能具有商业价值的单抗N6LS，例如VRC07和10E8。三聚体疫苗和多肽结合物也有望成为潜在的产品。随着我们沿着开发道路前进，对这些分子的需求增加了，要求开发小组进一步改进工艺和测试方法，以跟上需求。

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.