Production Core

由于生产生物药物的传统方法既不能提供成本结构，也不能解决防止性传播感染所需的大量低成本生物药物，因此正在建立替代制造平台，如工厂。Production Core将负责生产植物制成的试剂，以支持这三个研究项目；这些试剂包括单抗和亚单位疫苗。生产核心将由在植物生物技术方面拥有丰富经验的人员组成，并将利用可用的“DNA工具箱元素”，如表达载体、DNA调控序列、编码可选择标记的基因，以及我们的研究团队在过去10多年的植物生物制药研究中使用的其他材料。下面提到的绩效场地的一个特别重要的组成部分是进入美国农业部批准的生物安全2级(BL-2)温室和对制药厂进行批准的现场测试的人员。核心将利用不同的植物表达系统来满足两个关键需求：第一，快速生产重组蛋白质，以在临床前研究中评估它们的特性；第二，强大和成本效益高的植物生产系统，可以很容易地增加，以提供大规模供应。此外，Core将开发用于临床试验的单抗的纯化方案，并定义用于使用植物来源的抗原的粘膜免疫的植物加工方案。总体而言，核心将是 负责生产克隆单抗以支持项目1，为项目2生产疫苗原，以及为项目3建议的临床试验生产单抗和疫苗原GMP。

Since traditional methods of producing biopharmaceuticals can provide neither the cost structure nor the capacity to address the large volume of low cost biopharmaceuticals required for protection against sexually transtmitted infections, alternate manufacturing platforms, such as plants, are being established. The Production Core will be responsible for production of plant made reagents to support the three research projects; these reagents include both monoclonal antibodies and subunit vaccines. The production core will be staffed by personnel with extensive prior experience in plant biotechnology, and will draw upon available reserves of "DNA toolbox elements" such as expression vectors, DNA regulatory sequences, genes encoding selectable markers, and other materials utilized by our research teams over the last 10+ years of research on plant made biopharmaceuticals. A particularily important component of the performance sites noted below are access to USDA approved Biosafety level 2 (BL-2) greenhouses and personnel who have conducted approved field tests of pharmaceutical producing plants. The Core will utilize different plant expression systems to meet two key needs: first, a rapid production of recombinant proteins to evaluate their properties in preclinical studies; and second, robust and cost-effective plant production systems that can be easily increased to provide large-scale supply. In addition, the Core will develop the purification protocols for monoclonal antibodies to be used in clinical trials, and define plant processing protocols to be used for mucosal immunization using the plant-derived antigens. In total, the Core will be responsible for production of cloned MAbs to support Project 1, production of vaccinogens for Project 2, and GMP production of MAbs and vaccinogens for the clinical trials proposed in Project 3.