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).
