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    • 3. 发明申请
    • Novel Cryopreservation Bags and method of use thereof for Closed System, High Capacity Cell-Banking
    • 新型冷冻保存袋及其封闭系统,高容量细胞库的使用方法
    • US20160369225A1
    • 2016-12-22
    • US14826720
    • 2015-08-14
    • Merial Inc.
    • Hervé François Coupier
    • C12M1/00C12M1/12C12M1/34
    • C12M45/22A01N1/0268A61J1/10A61J1/1462A61J1/1475B01L3/505B01L9/00B01L2300/021B01L2300/0681B01L2300/0809B01L2300/1894C12M23/14C12M23/26C12M37/00C12M37/02C12M37/04C12M41/44
    • The disclosure provides a cell freezing and storage bag assembly and a method for using the assembly in banking eukaryotic cells for later seed train expansion. The bag is constructed principally of fluorinated ethylene propylene (FEP) fabric, and is designed to be filled such that the cell suspension has a very thin cross-section. The bag design includes at least an inlet conduit and an outlet or inoculation conduit, which can be sterilely welded to the source of the eukaryotic cells. The use of at least two sterile-weldable conduits allows for “closed system” filling of the bags, which significantly reduces the risk of contamination relative to other cell-banking methods. The bag also include a sleeve, which can be thermo-welded to form an enclosure, which protects the inlet and outlet conduits against contamination and mechanical damage during freezing, storage and subsequent thawing. In the method, once each bag is filled, its corresponding inlet conduit is sealed, and both the inlet and outlet conduits are enclosed within the bag's sleeve. This closed system method obviates the need for sterile environments (e.g. laminar flow unit).
    • 本公开提供了一种细胞冷冻和储存袋组件以及用于在银行真核细胞中使用该组件用于后续种子列扩展的方法。 该袋主要由氟化乙烯丙烯(FEP)织物构成,并且被设计成填充,使得细胞悬浮液具有非常薄的横截面。 袋设计包括至少一个入口管道和出口或接种管道,其可以无菌地焊接到真核细胞源。 使用至少两个无菌可焊接管道允许袋子的“封闭系统”填充,相对于其他细胞银行方法,这显着降低了污染的风险。 该袋还包括套筒,其可以被热焊接以形成外壳,其保护入口和出口管道免受冷冻,储存和随后解冻期间的污染和机械损坏。 在该方法中,一旦每个袋子被填充,其对应的入口管道被密封,并且入口和出口管道都被封装在袋子的套筒内。 这种封闭的系统方法消除了对无菌环境(例如层流单元)的需要。