DK3030578T3 - Fremgangsmåde til fjernelse af kontaminanter - Google Patents

Fremgangsmåde til fjernelse af kontaminanter Download PDF

Info

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
Application number
DK14833626.6T
Other languages
English (en)
Inventor
Gary Warren
Yvonne Vucica
Christoph Kempf
Martin Stucki
Original Assignee
Csl 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 Csl Ltd filed Critical Csl Ltd
Application granted granted Critical
Publication of DK3030578T3 publication Critical patent/DK3030578T3/da

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/775Apolipopeptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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

  • 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.
DK14833626.6T 2013-08-08 2014-08-08 Fremgangsmåde til fjernelse af kontaminanter DK3030578T3 (da)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

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

Similar Documents

Publication Publication Date Title
US11732028B2 (en) Contaminant removal method
ES2221957T5 (es) Método para la eliminación cromatográfica de priones.
AU2009202827B2 (en) Method of purifying apolipoprotein A-1
WO2014186350A1 (en) Purification of recombinantly produced polypeptides
US20170166626A1 (en) Albumin-purification method comprising a nanofiltration step, solution, and composition for therapeutic use containing the same
US8013122B2 (en) Method of purifying apolipoprotein A-1
RU2681413C2 (ru) Способы получения нового поколения безопасных с биологической точки зрения продуктов klh, применяемых для лечения рака, для разработки коньюгированных терапевтических вакцин и в качестве стимулирующих средств
KR20170008882A (ko) 암 치료용, 접합 치료 백신의 개발용, 및 접종제용으로 사용되는 생물학적으로 안전한 klh 제품의 신규 생성을 위한 제조 방법
ES2547425T3 (es) Proceso para la preparación de un concentrado del FV con virus inactivados que se inicia a partir del suero humano, a un nivel de escala industrial