Quality & Manufacturing

Hemopure and Oxyglobin are purified, sterile solutions of polymerized bovine hemoglobin, formulated at a concentration of 13g/dl in a balanced electrolyte solution. They are manufactured using a validated, commercial scale production process. Extensive purification of hemoglobin involves an automated state-of- the-art process consisting of multiple separation and filtration steps including specific hemoglobin isolation by large-scale, high-pressure ion exchange liquid chromatography. During the manufacturing process hemoglobin is crosslinked and polymerized by reaction with glutaraldehyde under totally automated procedures. We have recently consolidated all manufacturing activities at our site in Souderton PA, where the facility is undergoing a multimillion dollar expansion to accommodate increased capacity for all production steps from collection of starting materials through aseptic fill. Potential microbial contamination is monitored by bioburden and endotoxin testing performed throughout the processing of the drug substance.  The extensive filtration, chemical purification and polymerization process used in the manufacturing process removes and inactivates possible bacterial and viral contaminants.  This has been demonstrated by viral clearance studies which have been carried out during the various production phases of   Both RNA and DNA viruses, as well as enveloped and non-enveloped viruses have been shown to be cleared by the production process.  A comprehensive quality management system, assures ongoing adherence to international cGMP, and all applicable regulations and standards. The final products are packaged in transparent flexible infusion bags that are heat sealed within a transparent oxygen barrier overwrap. They are room temperature stable for at least three years, and can be immediately infused without  reconstitution or  type and cross-match.

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