Practical Considerations in the Development of Hemoglobin-Based Oxygen Therapeutics

Hae      Won Kim; Timothy      N. Estep

Abstract

The development of hemoglobin based oxygen therapeutics (HBOCs) requires consideration of a number of factors. While the enabling technology derives from fundamental research on protein biochemistry and biological interactions, translation of these research insights into usable medical therapeutics demands the application of considerable technical expertise and consideration and reconciliation of a myriad of manufacturing, medical, and regulatory requirements. The HBOC development challenge is further exacerbated by the extremely high intravenous doses required for many of the indications contemplated for these products, which in turn implies an extremely high level of purity is required. This communication discusses several of the important product configuration and developmental considerations that impact the translation of fundamental research discoveries on HBOCs into usable medical therapeutics.

Keywords: cGMP, dosing, HBOC development, manufacture, oxygen therapeutics, practical issues, quality control, regulatory compliance, Optro®, product development.