Polymerized, pyridoxalated stroma-free hemoglobin (Poly PSFH), made from outdated human blood, has excellent attributes for use as a blood substitute. A hypothetical larger scale process for the production of Poly PSFH is detailed, and facility design and cost estimates are presented. This paper gives the opportunity to discuss the engineering activities of process scope definition, utilities selection, and aseptic processing techniques, etc. Compliance with cGMP and other FDA regulation will also be discussed.
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