Apex Bioscience, Inc.

Apex Biosciences, Inc.

Breonics Inc.

Cyrus John Stacey

Todd Talarico

Christopher Thomas Privalle

Todd Lewis Talarico

The present invention employs a dissolved activated polyethylene glycol (aPEG) or related molecule that has been passed through a filtration means for the substantial reduction of bioburden or endotoxin levels in the aPEG solution. The resulting filtered aPEG solution can be used for the preparation of a PEGylated hemoglobin solution containing substantially reduced levels of bioburden or endotoxin.

Methods for purification of an activated PEG solution and for the synthesis of a modified hemoglobin solution

The present invention employs a filtration step during the hemoglobin purification process that substantially decreases viral contamination of a hemoglobin solution. The filtration means can be used to separate hemoglobin and several endogenous antioxidant enzymes from red blood cell stroma and potential adventitious agents. The purified hemoglobin/antioxidant composition is then subjected to a chemical modification process. The resulting modified hemoglobin/antioxidant composition is then fractionated to remove unmodified hemoglobin species and residual reactants, formulated in electrolytes and rendered sterile. The resulting modified hemoglobin product is substantially free of viral contamination and contains at least one endogenous antioxidant enzyme that retains antioxidant activity.

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Raleigh, NC, United States of America

Cyrus John Stacey