ES2641042T8 - Procedimiento para la fabricación de un fármaco proteínico - Google Patents
Procedimiento para la fabricación de un fármaco proteínico Download PDFInfo
- 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
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/14—Pressure control
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/18—Details relating to membrane separation process operations and control pH control
-
- Y—GENERAL 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against 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)
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)
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)
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 |
-
2012
- 2012-06-22 US US14/127,291 patent/US9359397B2/en active Active
- 2012-06-22 JP JP2013521630A patent/JP5711369B2/ja active Active
- 2012-06-22 WO PCT/JP2012/065987 patent/WO2012176876A1/ja active Application Filing
- 2012-06-22 CN CN201280030636.XA patent/CN103608352A/zh active Pending
- 2012-06-22 ES ES12803267.9T patent/ES2641042T3/es active Active
- 2012-06-22 EP EP12803267.9A patent/EP2725033B1/en active Active
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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