Methods of producing membrane vesicles

C - Chemistry – Metallurgy – 12 – N

Patent

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Details

C12N 5/078 (2010.01) C12N 5/07 (2010.01) C12N 5/0784 (2010.01) A61K 39/00 (2006.01) C07K 17/02 (2006.01) C12N 5/02 (2006.01) G01N 33/53 (2006.01) G01N 33/543 (2006.01)

Patent

CA 2407225

The present invention relates to methods of preparing biological material, for use in various experimental, diagnostic or therapeutic uses, including immunotherapy treatment or prophylaxy of tumors. More particularly, the present invention relates to methods of preparing membrane vesicles (in particular exosomes) released by various types of mammalian cells, comprising diafiltration and/or density cushion centrifugation. The invention also provides novel methods for characterizing and analyzing exosome preparations, which can be used in quality control assay for the purpose of pharmaceutical product production. The invention is suitable to produce pharmaceutical grade preparations of such membrane vesicles and to fully characterize said preparations, for use in human beings.

L'invention concerne des procédés de préparation de matériau biologique destiné à différents usages expérimentaux, de diagnostic ou thérapeutiques y compris en immunothérapie ou en prophylaxie de tumeurs. Elle concerne plus particulièrement des procédés de préparation de vésicules membranaires (en particulier des exosomes), libérés par différents types de cellules de mammifères, qui comprennent des étapes de diafiltration et/ou de centrifugation à coussin de densité. L'invention concerne aussi de méthodes de caractérisation et d'analyse des préparations d'exosomes qui peuvent être utilisées dans les essais de contrôle qualité pour les besoins de productions de produits pharmaceutiques. L'invention convient pour la production de préparations de qualité pharmaceutique de tels vésicules membranaires et pour la caractérisation complète de ces préparations, destinées à être utilisées chez l'homme.

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