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    METAL COLLOID SOLUTION
    1.
    发明公开
    METAL COLLOID SOLUTION 有权
    一种用于测试病毒清除过滤器的膜，用于制备病毒清除过滤器的膜的金属胶体溶液和测试使用金属胶体溶液的

    公开(公告)号：EP1647345A1

    公开(公告)日：2006-04-19

    申请号：EP04747659.3

    申请日：2004-07-16

    Applicant: Asahi Kasei Medical Co., Ltd.

    Inventor： HONGO, Tomoko ,  HAMASAKI, Naoko ,  IDE, Shoichi ,  YAMAGUCHI, Fumihiko ,  Kubozaki, Mitsunori

    IPC: B22F9/24 ,  B01D65/10 ,  B01J13/00 ,  G01N15/08

    CPC classification number: B01D65/102 ,  A61K33/24 ,  A61K45/06 ,  B01J13/0043 ,  Y02A50/465

    Abstract: A colloid solution that exhibits storage stability and pH stability, being useful as viral substitute particles for use in an integrity test for virus removal membrane. In particular, a metal colloid solution characterized in that it comprises metal particles or metal compound particles of 1 to 100 nm average diameter, a water soluble high-molecular-weight dispersant having an N group and water and/or a water soluble organic solvent, the metal colloid solution being stable for a prolonged period of time and being stable in at least pH values ranging from 4 to 11.

    Abstract translation: 胶体溶液做展品的储存稳定性和pH稳定性，而且该病毒颗粒代替用于对病毒除去膜的完整性测试是有用的。 特别是，在为特征的金属胶体溶液做了包含金属颗粒或1至100纳米的平均直径的金属化合物粒子，具有溶剂的N-基团和水和/或水溶性有机水的水溶性高分子量分散剂， 金属胶体溶液是用于在延长的时间内是稳定的，并且在至少pH值下范围从4至11是稳定的

    METHOD FOR PRODUCING PROTEIN PREPARATION
    2.
    发明授权
    METHOD FOR PRODUCING PROTEIN PREPARATION 有权
    生产蛋白质制剂的方法

    公开(公告)号：EP2725033B1

    公开(公告)日：2017-08-09

    申请号：EP12803267.9

    申请日：2012-06-22

    Applicant: Asahi Kasei Medical Co., Ltd.

    Inventor： HONGO, Tomoko ,  HAYASHIDA, Hirohisa

    IPC: C07K1/34 ,  A61K9/08 ,  A61K38/00 ,  A61K39/395 ,  B01D61/14 ,  B01D61/22 ,  B01D71/10 ,  B01D71/26 ,  B01D71/34 ,  B01D71/68 ,  C07K16/00

    CPC classification number: C07K1/34 ,  A61K38/00 ,  B01D61/14 ,  B01D2311/14 ,  B01D2311/18 ,  C07K16/00 ,  C07K16/065 ,  Y02A50/463

    Abstract: The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cm 2 or lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0 ‰¤ Y ‰¤ 150X - 590 (Equation 1) and 3.5 ‰¤ X ‰¤ 8.0 (Equation 5) or the following equations 4 and 5: Y = 0 (Equation 4) and 3.5 ‰¤ X ‰¤ 8.0 (Equation 5).

    Abstract translation: 本发明提供了一种制备无病毒蛋白质药物的方法，包括（a）过滤步骤，通过小孔病毒去除膜过滤含病毒蛋白质溶液以获得无病毒蛋白质溶液，过滤 步骤（a）包括（q）低压过滤步骤，以0.30kgf / cm 2或更低的过滤压力通过小孔病毒去除膜过滤溶液以获得无病毒蛋白质溶液，其中 在低压过滤步骤（q）中过滤之前的溶液具有满足以下等式1和5的pH（X）和盐离子强度（Y（mM））：0≤Y≤150X-590 （方程式1）和3.5方程式5或方程式4和方程式5：Y = 0（方程4）和3.5方程式（方程式5）。

    VIRUS REMOVAL MEMBRANE AND METHOD FOR MANUFACTURING VIRUS REMOVAL MEMBRANE
    6.
    发明公开
    VIRUS REMOVAL MEMBRANE AND METHOD FOR MANUFACTURING VIRUS REMOVAL MEMBRANE 审中-公开

    公开(公告)号：EP3437725A1

    公开(公告)日：2019-02-06

    申请号：EP17775408.2

    申请日：2017-03-30

    Applicant: Asahi Kasei Medical Co., Ltd.

    Inventor： FUTAMURA, Akika ,  KON, Yusuke ,  HONGO, Tomoko

    IPC: B01D69/02 ,  B01D65/10 ,  B01D69/06 ,  B01D69/08 ,  B01D69/12 ,  B01D71/10 ,  D01D5/24 ,  D01F2/04

    Abstract: A virus removal membrane for removing viruses from a protein-containing solution, the virus removal membrane including cellulose, and a primary-side surface through which the protein-containing solution is to be applied and a secondary-side surface from which a permeate that has permeated the virus removal membrane is to be flowed, wherein a bubble point is 0.5 MPa or more and 1.0 MPa or less; and when a solution containing gold colloids having a diameter of 30 nm is applied through the primary-side surface to the virus removal membrane to allow the virus removal membrane to capture the gold colloids for measurement of brightness in a cross section of the virus removal membrane, a value obtained by dividing a standard deviation of a value of an area of a spectrum of variation in the brightness by an average of the value of the area of the spectrum of variation in the brightness is 0.01 or more and 0.30 or less.

    METHOD FOR REMOVING VIRUSES IN HIGH-CONCENTRATION MONOCLONAL ANTIBODY SOLUTION
    9.
    发明公开
    METHOD FOR REMOVING VIRUSES IN HIGH-CONCENTRATION MONOCLONAL ANTIBODY SOLUTION 有权
    程序对清除病毒从高浓溶液单克隆抗体

    公开(公告)号：EP2412817A1

    公开(公告)日：2012-02-01

    申请号：EP10755721.7

    申请日：2010-03-26

    Applicant: Asahi Kasei Medical Co., Ltd.

    Inventor： HONGO, Tomoko ,  KOMURO, Masayasu

    IPC: C12P21/08 ,  C07K1/34

    CPC classification number: C07K1/34 ,  C07K16/065

    Abstract: An object of the present invention is to provide a method for removing even small viruses from a high concentration monoclonal antibody solution using a membrane, and thus for recovering the antibody within a short time at high yield in the form of a filtrate. The present invention provides a method for producing a preparation containing a monoclonal antibody, which comprises a step of removing viruses by filtering viruses in a monoclonal antibody solution using a virus-removing membrane, wherein
    (1) the monomer content of the monoclonal antibody accounts for 90% or more;
    (2) the monoclonal antibody concentration in the monoclonal antibody solution ranges from 20 mg/ml to 100 mg/ml;
    (3) the monoclonal antibody solution contains at least a basic amino acid; and
    (4) the parvovirus removal rate of the virus-removing membrane satisfies the following conditions: LRV (Log Reduction Value: logarithmic reduction value) ≧ 4.

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