Core--Production Facility

由于传统的生产生物药物的方法既不能提供成本结构，也不能提供能力来处理防止性传播感染所需的大量低成本生物药物，因此正在建立替代的生产平台，如工厂。生产中心将负责生产工厂制造的试剂，以支持三个研究项目;这些试剂包括单克隆抗体和亚单位疫苗。生产核心将由在植物生物技术方面具有丰富经验的人员组成，并将利用“DNA工具箱元素”的可用储备，如表达载体，DNA调控序列，编码选择标记的基因以及我们的研究团队在过去10多年来对植物制成的生物药物的研究中使用的其他材料。下面提到的绩效现场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实地测试的人员。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，以评估其在临床前研究中的特性;第二，强大且具有成本效益的植物生产系统，可以很容易地增加以提供大规模供应。此外，核心将开发用于临床试验的单克隆抗体的纯化方案，并定义用于使用植物来源抗原进行粘膜免疫的植物处理方案。总的来说，核心将是 负责生产支持项目1的克隆单克隆抗体，生产项目2的疫苗原，生产项目3中拟定的临床试验的单克隆抗体和疫苗原。

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.