Manufacturing

Facilities

OPK Biotech's research and development laboratories, and state-of-the-art bioprocessing facility are located adjacent to each other in Cambridge, Massachusetts. An intermediate manufacturing facility is located in Souderton, Pennsylvania. Both Hemopure and Oxyglobin have been produced since 1991.

Capacity

These facilities provide sufficient manufacturing capacity to support commercial demand for the company's veterinary product Oxyglobin and initial commercialization and continued clinical development of Hemopure for human use. The company's facilities have a validated process with an annual production capacity of 77,000 Hemopure units (250 ml/unit) or approximately 347,000 Oxyglobin units (125 ml/unit) or 647,000 of the smaller Oxyglobin units (60 ml/unit), or any combination thereof. This manufacturing facility has the capacity to produce up to approximately 100,000 Hemopure units per year upon further validation. Much of the engineering and design for a potential future manufacturing facility designed to produce 500,000 Hemopure units per year has been completed.

Manufacturing Team

We use proprietary and patented purification and polymerization processes in the manufacture of our oxygen therapeutic products. Our scientific and engineering team has designed and managed the construction of our large-scale process specific equipment and our commercial scale manufacturing facilities. In addition, this team developed the proprietary computer program that operates and monitors most aspects of this process.

Manufacturing Process

Manufacture of Hemopure and Oxyglobin occurs in four major steps: First, bovine blood is processed to remove plasma and then to remove the hemoglobin protein from red blood cells. The hemoglobin is then purified of other red cell proteins. Next, the purified hemoglobin is stabilized by the addition of a cross-linking agent to form hemoglobin polymers, or masses of molecules bound together. For Hemopure there is an additional filtering step to remove the smaller hemoglobin molecules. For both Hemopure and Oxyglobin the polymers are then placed in a solution suitable for infusion. Finally, we put the product through sterilizing filters and into sterile bags.

Validation

Our process has been validated, in accordance with regulatory agency guidelines, to remove potential pathogens in the raw material. Validation requires repeated testing to document that the process consistently meets performance requirements. 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.