BIOMEDICAL (BASIC)

我们快速通道合同申请的第二阶段SBIR组成部分的目标是开发规模扩大程序，以生产足够数量的GMP级PEG-Hb¿，以满足对hboc基础研究感兴趣的美国研究人员的研究需求。我们将使用在第一阶段SBIR组分中鉴定的PEG-Hb优化配方作为起始材料。我们用于生产第一阶段最终产品的程序将作为扩大PEG-Hb生产的起点。扩大规模过程将包括三个并行任务(更具体地说)定义包括牛血红蛋白的大规模纯化和合成的PEG-Hb适当配方(任务1,过程的示意图见图1),验证一个干净的房间延长药品以满足cGMP规范(任务2)和设计、施工所需的设备扩大生产规模的PEG-Hb将安装在洁净室(任务3)。

The objective of this phase II SBIR component of our Fast-Track contract application is to develop scale up procedures to produce sufficient quantities of GMP grade PEG-Hb ¿to satisfy the research needs of U.S. investigators interested in pursuing fundamental research studies on HBOCs.¿ We will be using as a starting material the optimized formulation of PEG-Hb identified in the phase I SBIR component. The procedures that we employed to produce the phase I final product will be used as a starting point for scale up production of PEG-Hb. The scale up process will involve three parallel tasks (defined more specifically below) including the large scale purification of bovine hemoglobin and synthesis of PEG-Hb in its appropriate formulation (Task 1, see Figure 1 for a schematic of the process), validation of a clean room at Prolong Pharmaceuticals to meet cGMP specifications (Task 2) and design and construction of the equipment required for the scale up production of PEG-Hb which will be installed in the clean room (Task 3).