Biotech manufacturers are taking various approaches to eliminating prions from their operations. Avoiding animal derivatives entirely is a holy grail for many companies, says Jerold Martin, Senior Vice President and Global Technical Director at Pall Corp.'s Life Sciences Division ( ). As an interim step, manufacturers are moving to non-bovine materials whenever possible, says Mary Gustafson, Senior Director of the Plasma Protein Therapeutics Assn. (PPTA; ), which represents plasma protein drug manufacturers. For Serologicals Corp., ensuring product safety has meant using raw materials from younger cattle, using beef not dairy cows, sourcing animals from disease-free regions [such as New Zealand and Australia], and maintaining certificates of suitability, according to CEO David Dodd. The company is also using a new process, developed inhouse and patented earlier this year, to make its EX-CYTE cell culture growth medium. The process uses highly alkaline solutions to deactivate the prions without damaging biological activity of the end product. "Biotech companies are still very confident [about the safety of their animal derivatives supplies], but can't be sure," says Pall's Martin. After all, the were, until very recently, on the list of "BSE-free" nations. "Interest in preventative systems--insurance policies for existing manufacturing operations--is growing," he says. At least one manufacturer, the heparin producer Celsus Laboratories ( ) is using inhouse immunoassays to test its products, and is making the claim that its heparin is prion-free Prions pose a number of cleaning and validation questions. Currently, there are no comprehensive cleaning guidelines to ensure complete prion removal, and no single decontamination method has been proven to be 100% effective, as Peter Burke, Vice President and Chief Technology Officer of Steris Corp. ( ) said when he testified before the FDA last year. Current decontamination methods are based on recommendations from the World Health Organization, he said, but there are
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In July, the U.S. Food and Drug Administration issued a final interim rule limiting the types of animal-derived materials that can be used to manufacture animal feed, cosmetics, and food supplements.
In plasma manufacturing, Martin says, charge-depth and viral filtration can be used to remove prions, as can membrane chromatography. However, viral filtration can only remove prions that have...
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New Decontamination Method Kills Prions Radio-frequency gas-plasma cleaning, a technology used in the electronics industry, has been found useful for medical devices. The decontamination method clears...
Abnormal prion protein detection improved Researchers at the Serono Pharmaceutical Research Institute (Geneva) have developed a procedure that they believe will greatly improve the sensitivity of...