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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: dalroi who wrote (6945)	7/26/1999 11:38:00 PM
From: Vector1	Read Replies (1) \| Respond to of 9719

From the filed S-1 Raw Material Source Biopure's products consist of bovine hemoglobin that has been purified, chemically modified and cross-linked for stability. Controlled herds of U.S. cattle destined for meat processing provide the raw material used in Biopure's products. Biopure monitors the source, health, location, feed consumption and quality of the cattle to be used as a raw material source, a safety standard that is not and cannot be established for donated human blood. Suppliers to Biopure contract to maintain traceable records on animal origin, health, feed and care to assure the use of known, healthy animals. Raw Material Collection At a high volume slaughterhouse, Biopure collects bovine whole blood into individual presanitized containers and transports them to a separation facility. Following blood collection, the animals pass U.S. Department of Agriculture, or USDA, inspection for use as beef for human consumption. If an animal is not approved for human consumption, Biopure also rejects the corresponding container of whole blood. The USDA considers the United States to be free of pathogens associated with "mad cow disease". Safety In addition to safety from bacterial and viral pathogens, such as those leading to AIDS and hepatitis, Biopure's sourcing and manufacturing processes safeguard humans from potential risks associated with diseases including transmissible spongiform encephalopathies, more commonly known as the cause of diseases such as "mad cow disease". 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. Biopure complies with, and believes it exceeds, all current guidelines regarding such risks for human pharmaceutical products. Bovine red blood cells are considered to be safe, and blood generally has been found to have little or no potential for transmitting transmissible spongiform encephalopathies. Furthermore, Biopure's patented purification and manufacturing process has been tested to demonstrate that the potential risk of infectious disease transmission is insignificant. Manufacturing Processes At Biopure's separation facility, a filtration process removes plasma proteins in the bovine blood. Washed cells are next placed in a centrifuge that separates the red blood cells from the rest of the blood. The hemoglobin is extracted from the red blood cells and is then diafiltered to remove red blood cell wall debris and other contaminants. The resulting material is a cell-free hemoglobin intermediate. A semi-continuous purification process involving a high performance liquid chromatography process purifies the hemoglobin intermediate. Next, the purified hemoglobin is polymerized, or linked, by the addition of a cross-linking agent. Polymerized and stabilized material is then fractionated and concentrated. The final product is filtered into sterilized batch holding tanks until it is sterile filled into bags.