Use of defibrinated blood for manufacture of a hemoglobin-based oxygen carrier
AssigneeBiopure Corporation
InventorsMaria S. Gawryl, Robert A. Houtchens, William R. Light
Life of this patent
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Abstract
Red blood cells are purified by defibrinating whole blood and then filtering the defibrinated whole blood, whereby at least a portion of a plasma component is separated from the red blood cells to form a suspension of red blood cells, thereby purifying the red blood cells. Whole blood is defibrinated by, for example, using a chemical coagulating agent or mechanical agitation. Separation of the plasma component from red blood cells can be completed by, for example, diafiltration. The suspension of red blood cells can then be employed to produce a hemoglobin-based oxygen carrier.
Claims48
A method for purifying red blood cells, comprising the steps of:
- a) defibrinating whole blood, the whole blood including red blood cells and a plasma component;
- and thereafter
- b) filtering the whole blood, whereby at least a portion of the plasma is separated from the red blood cells to form a red blood cell suspension, thereby purifying the red blood cells.
A method for preparing a hemoglobin solution, comprising the steps of:
- a) defibrinating whole blood;
- b) separating red blood cells from the whole blood;
- and
- c) isolating hemoglobin molecules from the red blood cells, whereby a hemoglobin solution is formed.
A method for preparing a hemoglobin-based oxygen carrier, comprising the steps of:
- a) defibrinating whole blood;
- b) separating red blood cells from whole blood;
- c) isolating hemoglobin molecules of said cells to form a hemoglobin solution;
- and
- d) stabilizing the hemoglobin, thereby preparing the hemoglobin-based oxygen carrier.
The method of using defibrinated blood to manufacture a hemoglobin-based oxygen carrier, comprising the steps of:
- a) using collagen to defibrinate blood, thereby forming defibrinated blood;
- b) filtering the defibrinated blood through an 800 μm polypropylene filter and a 50 μm polypropylene filter;
- c) diluting the blood with sodium citrate solution (6.0 g/l sodium citrate dihydrate and 8.0 g/l sodium chloride in water for injection);
- d) reconcentrating the diluted blood solution back to its original volume through a 0.2 μm hollow fiber diafilter;
- e) diafiltering the reconcentrated blood solution, thereby washing the cells;
- f) separating the red blood cells from the white blood cells and platelets by centrifugation, thereby forming a red blood cell suspension;
- g) lysing the red blood cells to release hemoglobin by centrifugaton;
- h) mixing the red blood cell phase with water for injection and centrifuging, thereby forming a hemoglobin solution;
- i) deoxygenating the hemoglobin solution;
- j) polymerizing the deoxy-hemoglobin in a polymerization apparatus;
- k) crosslinking the polymerized deoxyhemoglobin with glutaraldehyde, thereby preparing a hemoglobin-based hemoglobin-based oxygen carrier;
- and
- l) preserving the hemoglobin-based oxygen carrier in a oxygen barrier primary package.
Dependencies are inferred from the claim text.