Dry-heat viral inactivation under controlled moisture...

A - Human Necessities – 61 – L

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A61L 2/04 (2006.01) A61L 2/00 (2006.01) C12N 7/04 (2006.01)

Patent

CA 2221077

A method rendering a biologically active protein composition substantially free of viruses comprising preparing lyophilized samples of the protein composition having a given moisture content, determining a minimum or threshold moisture content which, when the composition is heated to pasteurizing conditions will result in at least a 3.2 log 10 reduction in virus titer and then heating the sample under pasteurizing conditions that will result in at least a 3.2 log 10 reduction in virus titer while maintaining biological activity of the protein.

Méthode permettant d'obtenir une composition protéinique biologiquement active, pratiquement exempte de virus; la méthode consiste à préparer des échantillons lyophilisés de la composition protéinique avec une teneur en humidité donnée, à déterminer un minimum ou un seuil d'humidité qui, lorsque la composition est chauffée jusqu'au niveau de pasteurisation, entraîne une réduction d'au moins 3,2 log 10 du titre viral, puis à chauffer l'échantillon dans des conditions de pasteurisation entraînant une réduction d'au moins 3,2 log 10 du titre viral, tout en maintenant l'activité biologique de la protéine.

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