Product Safety

OPK Biotech LLC's Manufacturing Process Safeguards Against Infectious Agents

OPK Biotech LLC's manufacturing process for its oxygen therapeutic products, Oxyglobin^® for veterinary use and Hemopure^® for human use, incorporates controls to prevent the potential introduction of pathogens and employs purification processes that have been demonstrated to remove pathogens if present. The following information is provided to address potential concerns in light of the occurrence of bovine spongiform encephalopathy (BSE), or "Mad Cow's Disease," in Canada and in the United States.

Safety assurance is derived from:

• Managed herds in which the animals' country of origin, feed 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, and
• Approval of our products and the process to manufacture them by
       multiple regulatory agencies.

We have taken the necessary steps to ensure the purity and consistency of Hemopure and Oxyglobin. Our products consist of purified, chemically modified bovine hemoglobin that undergoes a pharmaceutical manufacturing process to safeguard against potential pathogens. This process employs patented purification techniques that have been demonstrated to remove or inactivate potential infectious agents, if present, including bacteria, viruses and TSE agents.

In addition, we source our raw material only from managed herds. The managed herd requirements are designed to prevent the introduction of potential pathogens and include documentation of the country of origin, medical history, feed (no mammalian protein) and young age of the cattle.

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. We comply with, and believe we exceed, all current guidelines regarding such risks for human pharmaceutical products, including raw material safeguards proposed by the FDA in January 2007. In addition, the European Directorate for the Quality of Medicines (EDQM) granted a "Certification of Suitability of Monographs of the European Pharmacopoeia" for our veterinary product, Oxyglobin, in 2001 and for Hemopure in fiscal 2003. In August 2005, the European Directorate issued updated certificates for both products. This certification is required for all human and veterinary medicinal products that are manufactured from ruminant materials and marketed in the European Union, and it represents the Council of Europe's official acknowledgment of the acceptability of Oxyglobin and Hemopure with regard to TSE agents.

• View the EDQM Certificate of Suitability for Oxyglobin. (Adobe PDF)