DK3030578T3 - Fremgangsmåde til fjernelse af kontaminanter - Google Patents
Fremgangsmåde til fjernelse af kontaminanter Download PDFInfo
- Publication number
- DK3030578T3 DK3030578T3 DK14833626.6T DK14833626T DK3030578T3 DK 3030578 T3 DK3030578 T3 DK 3030578T3 DK 14833626 T DK14833626 T DK 14833626T DK 3030578 T3 DK3030578 T3 DK 3030578T3
- Authority
- DK
- Denmark
- Prior art keywords
- apo
- virus
- solution
- range
- filtration
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/775—Apolipopeptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Toxicology (AREA)
- Hematology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Obesity (AREA)
- Water Supply & Treatment (AREA)
- Analytical Chemistry (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (12)
1. Fremgangsmåde til oprensning af apolipoprotein A-l (Apo A-l), som omfatter trinene: a) tilvejebringelse af en opløsning, der omfatter Apo A-l og guanidinhydrochlorid (GuHCI); og b) filtrering af opløsningen gennem et filter med en porestørrelse i et interval fra 15 nm til 35 nm, hvor opløsningen omfatter GuHCI ved en koncentration i et interval fra 1,3 til 3,2 M.
2. Fremgangsmåde ifølge krav 1, hvor opløsningen omfatter en Apo A-l-proteinkoncentration i et interval fra 5 til 30 g/l eller fra 5 til 20 g/l eller fra 7 til 12 g/l.
3. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor opløsningen omfatter GuHCI ved en koncentration, der reducerer eller hæmmer aggregering af Apo A-l.
4. Fremgangsmåde ifølge krav 3, hvor opløsningen omfatter GuHCI ved en koncentration i et interval fra 1,5 til 2,0 M.
5. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor pH i opløsningen er i et interval fra 7,1 til 7,5.
6. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor filtrering udføres ved et tryk i et interval fra 0,2 til 3,4 bar og ved en temperatur i et interval fra 18 til 26 °C.
7. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor opløsningen fremstilles ved hjælp af et eller flere af trinene: 1) suspension af Apo A-l-præcipitat i 4,0 til 4,6 M GuHCI; og/eller 2) fortynding af suspensionen til en Apo A-l-proteinkoncentration i et interval fra 5 til 30 g/l og/eller til en GuHCI-koncentration i et interval fra 1,3 M til 3,2 M.
8. Fremgangsmåde ifølge krav 1 eller krav 7, hvor der før trin a) udføres et varmebehandlingstrin til virusinaktivering eller efter trin b) udføres et varmebehandlingstrin til virusinaktivering.
9. Fremgangsmåde ifølge krav 8, hvor varmebehandlingen omfatter trinene: justering af pH i opløsningen i et interval fra 6,6 til 8,0; og efterfølgende opvarmning af opløsningen ved en temperatur på 55 til 61 °C i ca. 30 minutter til ca. 4 timer.
10. Fremgangsmåde ifølge krav 9, hvor opløsningen med et pH i intervallet fra 6,6 til 8,0 omfatter en GuHCI-koncentration i et interval fra 2,7 M til 3,9 M.
11. Fremgangsmåde ifølge et hvilket som helst af kravene 9 eller 10, hvor pH i opløsningen med et pH i intervallet fra 6,6 til 8,0 er i et interval fra 7,0 til 8,0.
12. Fremgangsmåde ifølge et hvilket som helst af kravene 9 til 11, hvor opløsningen med et pH i intervallet fra 6,6 til 8,0 fremstilles ved hjælp af trinene: 1) suspension af et Apo A-l-præcipitat i 4,0 til 4,6 M GuHCI; og 2) justering af GuHCI-koncentrationen i et interval fra 2,7 M til 3,9 M og pH i et interval fra 6,6 til 8,0.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13179755 | 2013-08-08 | ||
PCT/AU2014/000790 WO2015017888A1 (en) | 2013-08-08 | 2014-08-08 | Contaminant removal method |
Publications (1)
Publication Number | Publication Date |
---|---|
DK3030578T3 true DK3030578T3 (da) | 2018-10-15 |
Family
ID=48948309
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK14833626.6T DK3030578T3 (da) | 2013-08-08 | 2014-08-08 | Fremgangsmåde til fjernelse af kontaminanter |
Country Status (13)
Country | Link |
---|---|
US (3) | US10087235B2 (da) |
EP (2) | EP3030578B1 (da) |
JP (1) | JP6530394B2 (da) |
KR (1) | KR102437202B1 (da) |
CN (2) | CN109701004B (da) |
AU (1) | AU2014305646C1 (da) |
CA (1) | CA2920391C (da) |
DK (1) | DK3030578T3 (da) |
ES (1) | ES2689333T3 (da) |
HK (1) | HK1225737B (da) |
NZ (1) | NZ631126A (da) |
PL (1) | PL3030578T3 (da) |
WO (1) | WO2015017888A1 (da) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2014305646C1 (en) * | 2013-08-08 | 2019-01-17 | Csl Limited | Contaminant removal method |
BR112020016727A2 (pt) * | 2018-02-19 | 2020-12-15 | Bayer Healthcare Llc | Membrana filtrante modificada e método |
FR3090321B1 (fr) * | 2018-12-21 | 2023-07-14 | Lab Francais Du Fractionnement | Procédé de filtration du fibrinogène |
CN111351893A (zh) * | 2020-04-28 | 2020-06-30 | 黄河三角洲京博化工研究院有限公司 | 一种利用离子色谱检测盐酸胍样品中胍离子含量的方法 |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA1335077C (en) * | 1988-02-08 | 1995-04-04 | Henri Isliker | Process for the manufacture of apolipoproteins from human blood plasma or serum |
US5652339A (en) * | 1993-12-31 | 1997-07-29 | Rotkreuzstiftung Zentrallaboratorium | Method of producing reconstituted lipoproteins |
SE9500724D0 (sv) * | 1994-06-23 | 1995-02-24 | Pharmacia Ab | Filtrering |
SE9603068D0 (sv) * | 1996-08-23 | 1996-08-23 | Pharmacia & Upjohn Ab | Process for purifying a protein |
DE10211632A1 (de) | 2002-03-15 | 2003-10-09 | Aventis Behring Gmbh | Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration |
WO2003105989A1 (en) | 2002-06-14 | 2003-12-24 | Centocor, Inc. | Use of a clathrate modifier to promote passage of proteins during nanofiltration |
WO2009025754A2 (en) * | 2007-08-17 | 2009-02-26 | Csl Behring Gmbh | Methods for purification of alpha-1-antitrypsin and apolipoprotein a-i |
WO2009036460A2 (en) * | 2007-09-14 | 2009-03-19 | Ambrx, Inc. | Modified human apolipoprotein a-i polypeptides and their uses |
WO2011044545A2 (en) * | 2009-10-09 | 2011-04-14 | Sigalov Alexander B | Methods and compositions for targeted imaging |
WO2012000048A1 (en) * | 2010-06-30 | 2012-01-05 | Csl Limited | A reconstituted high density lipoprotein formulation and production method thereof |
HUE041797T2 (hu) * | 2011-02-07 | 2019-05-28 | Cerenis Therapeutics Holding Sa | Lipoprotein-komplexek és elõállításuk és alkalmazásuk |
US9125943B2 (en) | 2012-11-02 | 2015-09-08 | Csl Limited | Reconstituted HDL formulation |
MX2015016670A (es) | 2013-06-05 | 2016-07-15 | Csl Ltd | Proceso para preparar apolipoproteina a-i (apo- a-i). |
AU2014305646C1 (en) * | 2013-08-08 | 2019-01-17 | Csl Limited | Contaminant removal method |
CN104017076B (zh) * | 2014-01-06 | 2016-07-06 | 宁波博泰生物技术有限公司 | 载脂蛋白aⅰ抗血清的制备方法 |
-
2014
- 2014-08-08 AU AU2014305646A patent/AU2014305646C1/en active Active
- 2014-08-08 EP EP14833626.6A patent/EP3030578B1/en active Active
- 2014-08-08 CN CN201910195678.2A patent/CN109701004B/zh active Active
- 2014-08-08 PL PL14833626T patent/PL3030578T3/pl unknown
- 2014-08-08 EP EP18180083.0A patent/EP3418290A1/en active Pending
- 2014-08-08 US US14/910,424 patent/US10087235B2/en active Active
- 2014-08-08 CA CA2920391A patent/CA2920391C/en active Active
- 2014-08-08 JP JP2016532164A patent/JP6530394B2/ja active Active
- 2014-08-08 DK DK14833626.6T patent/DK3030578T3/da active
- 2014-08-08 WO PCT/AU2014/000790 patent/WO2015017888A1/en active Application Filing
- 2014-08-08 CN CN201480044463.6A patent/CN105452291B/zh active Active
- 2014-08-08 NZ NZ631126A patent/NZ631126A/en unknown
- 2014-08-08 KR KR1020167006225A patent/KR102437202B1/ko active IP Right Grant
- 2014-08-08 ES ES14833626.6T patent/ES2689333T3/es active Active
-
2016
- 2016-11-30 HK HK16113663A patent/HK1225737B/zh unknown
-
2018
- 2018-07-20 US US16/041,239 patent/US10730927B2/en active Active
-
2020
- 2020-07-31 US US16/945,312 patent/US11732028B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
US10730927B2 (en) | 2020-08-04 |
JP2016528233A (ja) | 2016-09-15 |
CN105452291A (zh) | 2016-03-30 |
KR102437202B1 (ko) | 2022-08-29 |
EP3030578B1 (en) | 2018-07-04 |
CN105452291B (zh) | 2019-03-19 |
US20190119354A1 (en) | 2019-04-25 |
US20210147509A1 (en) | 2021-05-20 |
JP6530394B2 (ja) | 2019-06-12 |
AU2014305646C1 (en) | 2019-01-17 |
EP3030578A1 (en) | 2016-06-15 |
ES2689333T3 (es) | 2018-11-13 |
NZ631126A (en) | 2018-06-29 |
EP3030578A4 (en) | 2017-04-26 |
AU2014305646B2 (en) | 2018-06-14 |
HK1225737B (zh) | 2017-09-15 |
CN109701004B (zh) | 2022-11-08 |
AU2014305646A1 (en) | 2016-02-18 |
US11732028B2 (en) | 2023-08-22 |
EP3418290A1 (en) | 2018-12-26 |
KR20160040299A (ko) | 2016-04-12 |
WO2015017888A1 (en) | 2015-02-12 |
US20160176947A1 (en) | 2016-06-23 |
US10087235B2 (en) | 2018-10-02 |
WO2015017888A8 (en) | 2015-10-01 |
PL3030578T3 (pl) | 2018-12-31 |
CN109701004A (zh) | 2019-05-03 |
CA2920391A1 (en) | 2015-02-12 |
CA2920391C (en) | 2023-03-28 |
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