Depth filters for disposable biotechnological processes

    公开(公告)号:US10786754B2

    公开(公告)日:2020-09-29

    申请号:US16058258

    申请日:2018-08-08

    Abstract: A process for the primary clarification of feeds, including chemically treated flocculated feeds, containing the target biomolecules of interest such as mAbs, mammalian cell cultures, or bacterial cell cultures, using a primary clarification depth filtration device without the use of a primary clarification centrifugation step or a primary clarification tangential flow microfiltration step. The primary clarification depth filtration device contains a porous depth filter having graded porous layers of varying pore ratings. The primary clarification depth filtration device filters fluid feeds, including chemically treated flocculated feeds containing flocculated cellular debris and colloidal particulates having a particle size distribution of approximately about 0.5 μm to 200 μm, at a flow rate of about 10 litres/m2/hr to about 100 litres/m2/hr. Kits and methods of using and making the same are also provided.

    HIGH CAPACITY COMPOSITE DEPTH FILTER MEDIA WITH LOW EXTRACTABLES
    12.
    发明申请
    HIGH CAPACITY COMPOSITE DEPTH FILTER MEDIA WITH LOW EXTRACTABLES 审中-公开
    高容量复合深度过滤介质与低提取物

    公开(公告)号:US20160114272A1

    公开(公告)日:2016-04-28

    申请号:US14890774

    申请日:2014-09-02

    Abstract: A depth filtration device for the clarification of biological fluids including a composite depth filter media having a nonwoven first layer integral with a second layer containing a polyaeryionitrile (PAN) fibers, a filter aid, and a wet-strength resin. The depth filter media exhibits increased creased binding capacity for soluble impurities such as DNA and host cells proteins from biological/cell culture feed-streams during secondary clarification and low-level impurity clearance of harvested cell culture fluids, such as those used for the manufacture of monoclonal antibodies. The depth filter media additionally exhibits significantly lower flushing requirements, resulting in lower levels of organic, inorganic and bioburden extractables released, high dirt holding capacities and good chemical and/or radiation resistance.

    Abstract translation: 一种用于澄清生物流体的深度过滤装置,包括具有与包含聚噻吩(PAN)纤维的第二层成一体的非织造第一层的复合深度过滤介质,助滤剂和湿强度树脂。 深度过滤介质在二次澄清过程中生物/细胞培养物料流中的可溶性杂质如DNA和宿主细胞蛋白质的增加的结合能力增加,并且收集的细胞培养液的低含量杂质清除,例如用于制造 单克隆抗体。 深度过滤介质还显示出显着降低的冲洗要求,导致释放的有机,无机和生物负载提取物水平较低,高污垢保持能力以及良好的化学和/或耐辐射性。

    Low Organic Extractable Depth Filter Media Processed with Solvent Extraction Method
    14.
    发明申请
    Low Organic Extractable Depth Filter Media Processed with Solvent Extraction Method 审中-公开
    用溶剂萃取法处理的低有机萃取深度过滤介质

    公开(公告)号:US20150133643A1

    公开(公告)日:2015-05-14

    申请号:US14400392

    申请日:2013-06-06

    CPC classification number: C07K1/34 C07K16/00 C12M47/02

    Abstract: Provided is a primary clarification depth filtration process of cell-culture feeds, including chemically treated flocculated feeds, containing target biomolecules of interest such as mAbs, mammalian cell cultures, or bacterial cell cultures, utilizing a primary clarification depth filtration device containing a media with significantly lower flushing requirements, resulting in lower levels of organic extractables released after media flushing, and increased throughput for the pre-treated feed streams, without the use of a primary clarification centrifugation step or primary clarification tangential flow microfiltration step. The primary clarification depth filtration device used in the primary clarification of fluid cell culture feeds, including chemically treated flocculated feeds containing flocculated cellular debris and/or colloidal particulates having a particle size distribution of about 0.5 μm to 200 um, contains a porous depth filter media having porous layers of varying pore ratings, and achieves the desired level, of total organic extractables (1-3 ppm) measured in the feed filtered through the media with, significantly lower flushing requirements. Kits and methods of using and making the same are also provided.

    Abstract translation: 提供了细胞培养饲料的初步澄清深度过滤方法,其包括化学处理的絮凝饲料,其包含感兴趣的目标生物分子,例如mAb,哺乳动物细胞培养物或细菌细胞培养物,利用含有显着的培养基的初级澄清深度过滤装置 更低的冲洗要求,导致在介质冲洗后释放的有机提取物水平较低,并且增加了预处理的进料流的通过量,而不使用初级澄清离心步骤或初级澄清切向流微量过滤步骤。 用于初步澄清流体细胞培养物料的初级澄清深度过滤装置,包括含有絮凝细胞碎片的化学处理的絮凝饲料和/或具有约0.5μm至200μm的粒度分布的胶体颗粒,其包含多孔深度过滤介质 具有不同孔径等级的多孔层,并达到在通过介质过滤的进料中测量的总有机可提取物(1-3ppm)的期望水平,显着降低了冲洗要求。 还提供了使用和制造相同的套件和方法。

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