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Drug Safety

Methods for clearing viruses and TSE agents from biologicals are under development

Published in Vaccine Weekly, December 21st, 2005

Robust methods for clearance of viruses and transmissible spongiform encephalopathy (TSE) agents from biologicals are under development.

According to a report from the United States, "The viral and transmissible spongiform encephalopathy (TSE) safety of therapeutics of biological origin (biologicals) is greatly influenced by the nature and degree of variability of the source material and by the mode of purification."

"Plasma-derived and recombinant DNA products currently have good viral safety records, but challenges remain. In general, large enveloped viruses are easier to remove from biologicals than small 'naked' viruses."

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