Methods of terminal sterilization of fibrinogen
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United States of America Patent
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Oct 14, 2003
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app pub date -
May 14, 1996
filing date -
May 14, 1996
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Abstract
The invention relates to methods of sterilizing biologically active products, particularly therapeutic or prophylactic products and the compositions obtained thereby. The methods include obtaining a dried sample containing an amount of trehalose sufficient to render heat stability to the product and exposing the dried sample to heating conditions at a temperature and for a duration sufficient to substantially inactivate viruses, especially non-lipid encapsulated viruses. The drying methods include both ambient drying conditions and lyophilization. The heating conditions include any known in the art and cover a wide range of temperatures and heating times. The compositions obtained contain stable products and do not contain measurable infectious virus, particularly parvovirus.
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