HbO2 Therapeutics' research and development laboratories, state-of-the-art bioprocessing, and purification facility are located in Souderton, Pennsylvania.
SOURCE OF HEMOGLOBIN
The active biological component in Hemopure® is polymerized bovine hemoglobin. Its manufacture consists of hemoglobin purification, chemical polymerization, and final packaging by sterile filtration. The Company collects fresh whole bovine blood from certified managed herds less than 30 months of age and includes documentation of the animal’s country of origin (USA) and their health monitoring. The program is under the supervision of a qualified veterinarian. Any animals sick or medically treated within 60 days before slaughter are not eligible for shipment and collection. Finally, there is a post-mortem inspection of each animal by a qualified US Department of Agriculture (USDA) inspector.
Manufacture of the products occurs in four major steps: first, bovine blood is collected and processed to remove plasma; second, the hemoglobin protein is removed from then red blood cells; third, the hemoglobin is purified of other red cell proteins; and fourth, the purified hemoglobin is stabilized by the addition of a cross-linking agent to form hemoglobin polymers, or proteins bound together. For the human product, an additional filtering step removes the unbound hemoglobin molecules. For both products, the polymers are then placed in a solution suitable for infusion. Finally, the products are put through sterilizing filters and into sterile bags.
The company's facilities have a validated process with an annual production capacity of 100,000 hemoglobin glutamer-250 (bovine) (HBOC-201) units (250 ml/unit) or approximately 350,000 Oxyglobin® units (125 ml/unit) or 700,000 of the smaller Oxyglobin® units (60 ml/unit), or any combination thereof. Much of the engineering and design has been completed for a potential future manufacturing facility designed to produce 500,000 HBOC-201 units per year.
VALIDATION AND PRODUCT SAFETY
The process has been validated, in accordance with regulatory agency guidelines, to remove potential pathogens in the raw material. Examples of pathogens include bacteria, viruses, such as those leading to hepatitis and AIDS, and the transmissible spongiform encephalopathy (TSE) agents that cause rare neurological disorders, such as "mad cow disease" and its human equivalent.
Health and regulatory authorities have given guidance directed at three factors to control these diseases: source of animals, nature of tissue used and manufacturing process. These three factors are addressed by supplier contracts that maintain traceable records on animal origin, health, feed and care, and by the validated blood collection and manufacturing processes.
Safety assurance is provided by:
Managed herds in which the animals' country of origin, feed, age and health are monitored;
Clearance studies that have demonstrated that our manufacturing process removes or inactivates potential pathogens;
External experts' analyses of the capability of our process to remove or inactivate pathogens;
Adherence with worldwide industry and regulatory standards;
Approval of our products and the process to manufacture them by multiple regulatory agencies.
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