OPK Biotech’s research and development laboratories and state-of-the-art bioprocessing facility are located adjacent to one another in Cambridge, Massachusetts with a purification facility in Souderton, Pennsylvania. Two products have been produced since 1991, one for human use and one for veterinary use.
The company's facilities have a validated process with an annual production capacity of 100,000 hemoblobin 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.
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 forth, 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, the polymers are then placed in a solution suitable for infusion. Finally, the products are put through sterilizing filters and into sterile bags.
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: