Quality control of hemoglobin-based blood substitutes.

Preparation and use of hemoglobin-based blood substitutes, from stroma-free hemoglobin (SFH or Hb) and its DPG analogue-modified derivatives (PLP-Hb, ATP-Hb etc.) without thorough characterization and quality control in animal or human testing have produced, and may continue to produce, artifacts in the finished product. Thus the development of such a natural substitute for the volume expansion and oxygen delivery functions of the blood will be impeded. A case is made for the use of affinity purified hemoglobin and modified hemoglobin as standard starting materials for the preparation of Hb-based blood substitute(s) in general, and in particular poly PLP-Hb. Development of a commercial scale blood-substitute is only possible after the safety and toxicity issues of substitutes have been resolved by applying rigorous quality control.