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    Virus filtration of cell culture media
    1.
    发明授权
    Virus filtration of cell culture media 有权

    公开(公告)号：US11421202B2

    公开(公告)日：2022-08-23

    申请号：US16816641

    申请日：2020-03-12

    Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

    Inventor： Wolfgang Mundt ,  Artur Mitterer ,  Manfred Reiter ,  Meinhard Hasslacher ,  Leopold Grillberger ,  Thomas Kreil

    IPC: C12N5/071 ,  A61L2/00 ,  C12M1/00 ,  C12M1/12

    Abstract: The invention relates to a method for removing a viral contaminant from a preparation, being a cell culture medium or at least a component of a cell culture medium. The method comprises subjecting said preparation to filtration for at least about 24 hours through a virus filter having an effective pore size of maximum about 75 nm. Further, the invention relates to the use of a virus filter in filtration of at least about 24 hours, wherein the virus filter has an effective pore size of maximum about 75 nm for the removal of viral contaminant from a preparation, being a cell culture medium or at least a component of a cell culture medium. In some embodiments the filtration according to the invention operates at a volumetric capacity of at least about 2000 L/m2. Further, the invention relates to the use of a preparation, being a cell culture medium or at least a component of a cell culture medium obtainable according to method of the invention for cell culture; pharmaceutical, diagnostic and/or cosmetic preparations as well as in food preparations.

    Method of predicting a performance characteristic of a plant or yeast hydrolysate and its use
    5.
    发明授权
    Method of predicting a performance characteristic of a plant or yeast hydrolysate and its use 有权

    公开(公告)号：US11650159B2

    公开(公告)日：2023-05-16

    申请号：US16694789

    申请日：2019-11-25

    Applicant: Takeda Pharmaceutical Company Limited

    Inventor： Renata Baldaszti-Juric ,  Leopold Grillberger ,  Wolfgang Langer ,  Manfred Reiter

    IPC: G01N21/64 ,  C12N5/00 ,  C12N7/00

    CPC classification number: G01N21/6486 ,  C12N5/0018 ,  C12N7/00 ,  G01N2021/6419 ,  G01N2201/1293

    Abstract: The present invention relates to a method of predicting a performance characteristic of a plant or yeast hydrolysate, wherein a plant or yeast hydrolysate sample is measured with 2D fluorescence spectroscopy in powder form. Said method comprises the steps for providing a model based on a predetermined value of a manufacturing parameter of interest. For this purpose a training set consisting of predetermined manufacturing parameter of interest (e.g volumetric productivity parameter, virus titer or cell number) and fluorescence spectroscopic data is used. The fluorescence spectroscopic data is correlated to the values of the manufacturing parameter of interest to obtain a calibration model/model parameters by applying multivariate data analysis. This calibration model is being used to predict the manufacturing parameter of interest for new samples dedicated for the manufacturing process. This prediction is used for a decision to accept or reject the lot which corresponds to the respective sample for use in the manufacturing process or for further evaluation depending on the pre-defined range of the manufacturing parameter of interest. The invention further relates to a method for preparation of a cell culture medium, preferably an animal protein free cell culture medium, a method for cultivating cells, a method for producing a recombinant target protein, a method for producing an immunogenic composition, whereby the above method of predicting a performance characteristic has been used for selecting the plant or yeast hydrolysate to be used in the manufacturing process.

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