公开(公告)号：US11780904B2

公开(公告)日：2023-10-10

申请号：US17086072

申请日：2020-10-30

Applicant: Takeda Pharmaceutical Company Limited

Inventor： Leopold Grillberger ,  Manfred Reiter ,  Wolfgang Mundt

IPC: C07K14/755 ,  C12N9/64 ,  A61K9/00 ,  A61K38/36 ,  A61K38/37 ,  C12P21/00 ,  A61K38/00

CPC classification number: C07K14/755 ,  A61K9/0019 ,  A61K38/36 ,  A61K38/37 ,  C12N9/6489 ,  C12P21/00 ,  A61K38/00 ,  C12N2500/24 ,  C12N2511/00 ,  C12Y304/24087

Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimericWF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.

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.

公开(公告)号：US11254921B2

公开(公告)日：2022-02-22

申请号：US16903185

申请日：2020-06-16

Applicant: Takeda Pharmaceutical Company Limited

Inventor： Leopold Grillberger ,  Alexandra Spenger ,  Meinhard Hasslacher ,  Rana Grillberger ,  Manfred Reiter

IPC: C12N9/64 ,  C12N5/071

Abstract: The present invention provides culture mediums that are useful for the expression of ADAMTS proteins, such as ADAMTS13. Methods for the expression and purification of ADAMTS proteins are also provided. In some embodiments, the mediums and methods of the invention are useful for the expression of ADAMTS proteins having high specific activities. Also provided are ADAMTS, e.g., ADAMTS13, protein compositions with high specific activities, which are expressed and purified according to the methods provided herein.

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.