A cryopreservation bag assembly for mammalian cell lines

C - Chemistry – Metallurgy – 12 – M

Patent

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Details

C12M 1/24 (2006.01) B65D 85/50 (2006.01) C12M 1/00 (2006.01) C12M 3/00 (2006.01) C12N 1/04 (2006.01)

Patent

CA 2446226

The invention is a novel cell freezing and storage bag assembly and method for using the assembly in the seed train expansion of mammalian cells. The bag is constructed principally of polytetrafluoroethylene fabric. The bag is designed to hold enough cells that a bioreactor can be inoculated directly. The bag is designed to be filled to a fraction of its maximum capacity so that the cell suspension has a very thin cross-section (less than about 10 millimeters). The bag design includes a transfer set that can be sterilely welded to the source of the mammalian cells. This sterile-weldable transfer set allows the bags to be filled quickly with minimal risk of contamination. In the method, once each bag is filled, it is sealed below the connection with the transfer set and the bag is cut "above" the new seal (on the same side of the seal as the transfer set). When a bioreactor is to be inoculated, the contents of the bag are drained via a sterile-weldable inoculation line. During freezing and storage, the inoculation line is protected from mechanical damage.

L'invention concerne un nouvel ensemble sachet de congélation et de conservation de cellules ainsi que son procédé d'utilisation dans l'expansion de chaînes de grains de cellules mammifères. Ce sachet, qui est principalement constitué de tissu de poly(tétrafluoroéthyléne), est conçu pour contenir une quantité de cellules suffisante pour inoculer directement un bioréacteur. Il est en outre conçu pour être rempli jusqu'à la fraction de sa capacité maximale de sorte que la suspension cellulaire présente une coupe transversale très mince (moins de 10 millimètres environ). La structure de se sachet comprend un ensemble de transfert pouvant être soudé de manière stérile à la source des cellules mammifères. Cet ensemble de transfert soudable de manière stérile permet de remplir rapidement les sachets avec un minimum de risque de contamination. Selon ce procédé, une fois le sachet rempli, celui-ci est soudé sous l'assemblage avec l'ensemble de transfert, puis coupé <= au-dessus >= du nouveau soudage (sur le même côté de soudage que l'ensemble de transfert). Lorsqu'un bioréacteur doit être inoculé, le contenu du sachet est drainé via une ligne d'inoculation soudable de manière stérile. Au cours de la congélation et de la conservation, la ligne d'inoculation est protégée des dommages mécaniques.

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