ES2641042T8 - Procedimiento para la fabricación de un fármaco proteínico - Google Patents

Procedimiento para la fabricación de un fármaco proteínico Download PDF

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Publication number
ES2641042T8
ES2641042T8 ES12803267.9T ES12803267T ES2641042T8 ES 2641042 T8 ES2641042 T8 ES 2641042T8 ES 12803267 T ES12803267 T ES 12803267T ES 2641042 T8 ES2641042 T8 ES 2641042T8
Authority
ES
Spain
Prior art keywords
procedure
manufacture
protein drug
drug
protein
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES12803267.9T
Other languages
English (en)
Other versions
ES2641042T3 (es
Inventor
Tomoko Hongo
Hirohisa HAYASHIDA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asahi Kasei Medical Co Ltd
Original Assignee
Asahi Kasei Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asahi Kasei Medical Co Ltd filed Critical Asahi Kasei Medical Co Ltd
Application granted granted Critical
Publication of ES2641042T3 publication Critical patent/ES2641042T3/es
Publication of ES2641042T8 publication Critical patent/ES2641042T8/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2311/00Details relating to membrane separation process operations and control
    • B01D2311/14Pressure control
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2311/00Details relating to membrane separation process operations and control
    • B01D2311/18Details relating to membrane separation process operations and control pH control
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Water Supply & Treatment (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
ES12803267.9T 2011-06-24 2012-06-22 Procedimiento para la fabricación de un fármaco proteínico Active ES2641042T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011141121 2011-06-24
JP2011141121 2011-06-24
PCT/JP2012/065987 WO2012176876A1 (ja) 2011-06-24 2012-06-22 蛋白製剤の製造方法

Publications (2)

Publication Number Publication Date
ES2641042T3 ES2641042T3 (es) 2017-11-07
ES2641042T8 true ES2641042T8 (es) 2018-10-16

Family

ID=47422704

Family Applications (1)

Application Number Title Priority Date Filing Date
ES12803267.9T Active ES2641042T3 (es) 2011-06-24 2012-06-22 Procedimiento para la fabricación de un fármaco proteínico

Country Status (6)

Country Link
US (1) US9359397B2 (es)
EP (1) EP2725033B1 (es)
JP (1) JP5711369B2 (es)
CN (1) CN103608352A (es)
ES (1) ES2641042T3 (es)
WO (1) WO2012176876A1 (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104099298B (zh) * 2013-04-12 2016-06-29 华中农业大学 一种犬细小病毒乳胶检测试剂及检测方法和应用
EP3274359B1 (en) * 2015-03-23 2022-11-02 Alexion Pharmaceuticals, Inc. Virus filtration
JP6731055B2 (ja) * 2016-08-09 2020-07-29 旭化成メディカル株式会社 ブタサーコウイルスが夾雑する溶液の処理方法
EP3535047A1 (en) * 2016-12-09 2019-09-11 Lonza Ltd Method for the reduction of viral titer in pharmaceuticals
US11590452B2 (en) 2017-06-12 2023-02-28 Asahi Kasei Medical Co., Ltd. Method for filtering protein-containing liquid
CN107226859B (zh) * 2017-08-10 2020-11-24 博雅生物制药集团股份有限公司 一种人凝血因子ⅷ的制备方法
KR20240000659A (ko) 2017-12-07 2024-01-02 후지모리 고교 가부시키가이샤 포트가 부착된 백 및 캡이 부착된 백
CN115181816B (zh) * 2022-08-10 2023-01-06 杭州纽创生物检测有限公司 一种超低病毒滴度体系中病毒滴度的检测方法及其应用

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4808315A (en) 1986-04-28 1989-02-28 Asahi Kasei Kogyo Kabushiki Kaisha Porous hollow fiber membrane and a method for the removal of a virus by using the same
US4857196A (en) 1987-08-07 1989-08-15 Asahi Kasei Kogyo Kabushiki Kaisha Porous hollow fiber membrane and a method for the removal of a virus by using the same
SE9500724D0 (sv) * 1994-06-23 1995-02-24 Pharmacia Ab Filtrering
CN1520885A (zh) 1997-10-23 2004-08-18 ������ҩ��ʽ���� 可室温贮存的免疫球蛋白静脉注射制剂
JP2001335509A (ja) 2000-05-31 2001-12-04 Nihon Pharmaceutical Co Ltd フィブリノーゲンを含有する溶液のウイルス除去法
US6365395B1 (en) 2000-11-03 2002-04-02 Millipore Corporation Process for removing protein aggregates and virus from a protein solution
DE10211632A1 (de) 2002-03-15 2003-10-09 Aventis Behring Gmbh Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration
WO2004035066A1 (ja) 2002-10-16 2004-04-29 Asahi Kasei Pharma Corporation 血漿製剤または血清製剤、及びその製造方法
FR2861395B1 (fr) 2003-10-23 2006-02-17 Lab Francais Du Fractionnement Facteur viii viralement securise a faible teneur en multimeres superieurs
ES2298096B1 (es) * 2008-01-08 2009-01-01 Grifols, S.A. Procedimiento para la obtencion de un concentrado de factor von willebrand o del complejo de factor viii/factor von willebrand y utilizacionde los mismos.
WO2010109920A1 (ja) * 2009-03-27 2010-09-30 旭化成メディカル株式会社 高濃度モノクローナル抗体溶液中のウイルス除去方法
FR2952539B1 (fr) * 2009-11-16 2012-01-13 Lab Francais Du Fractionnement Preparation d'un concentre de facteur h

Also Published As

Publication number Publication date
JPWO2012176876A1 (ja) 2015-02-23
EP2725033B1 (en) 2017-08-09
EP2725033A1 (en) 2014-04-30
WO2012176876A1 (ja) 2012-12-27
EP2725033A4 (en) 2015-04-22
JP5711369B2 (ja) 2015-04-30
CN103608352A (zh) 2014-02-26
ES2641042T3 (es) 2017-11-07
US20140199262A1 (en) 2014-07-17
US9359397B2 (en) 2016-06-07

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