DK3040346T3 - Fremgangsmåde til rensning af granulocyt-kolonistimulerende faktor, g-csf - Google Patents

Fremgangsmåde til rensning af granulocyt-kolonistimulerende faktor, g-csf Download PDF

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Publication number
DK3040346T3
DK3040346T3 DK16156518.9T DK16156518T DK3040346T3 DK 3040346 T3 DK3040346 T3 DK 3040346T3 DK 16156518 T DK16156518 T DK 16156518T DK 3040346 T3 DK3040346 T3 DK 3040346T3
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csf
rhg
buffer
resin
chromatography
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DK16156518.9T
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Stefan Winge
Gustav Gilljam
Maya Tiemeyer
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Octapharma Ag
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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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/53—Colony-stimulating factor [CSF]
    • C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/34—Size selective separation, e.g. size exclusion chromatography, gel filtration, permeation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3828—Ligand exchange chromatography, e.g. complexation, chelation or metal interaction chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3847—Multimodal interactions
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • 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
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • C07K14/475—Growth factors; Growth regulators
    • 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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • 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
    • C07K14/575—Hormones

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (8)

1. Fremgangsmåde til rensning af rekombinant human granulocyt-kolonisti-mulerende faktor (rhG-CSF) i en kromatografi-anvendende rensningssekvens kendetegnet ved, - at der finder i det mindste en kromatografi-anvendelse sted med anvendelse af en cap to MMC™-harpiks, - at rhG-CSF er bundet til capto MMC™-harpiks ved en pH-værdi, der andrager mellem 4 og 6, og - at rhG-CSF er elueret ved en pH-værdi, der andrager fra 5,5 til 6,5, og hvor elu-eringen finder sted med arginin udvisende en koncentration i området, der andrager fra 0,1 M til 2,0 M, - som option i kombination med et affinitets-ligand-kromatografi-trin med anvendelse af et gær-afledt Fab-fragment rettet mod rhG-CSF.
2. Fremgangsmåde ifølge krav 1, ved hvilken der anvendes en buffer-substans omfattende i det mindste en af substanserne udvalgt fra gruppen omfattende: natrium-citrat; histidin; 2-(4-(2-hydroxyethyl)-l-piperazinyl)-ethan-svovlsyre (MES); tris-base; og natriumacetat.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor det ikke-ioniske detergent er tilstede i en hvilken som helst af de anvendte buffere, hvilken ikke-ioniske detergent især er udvalgt blandt gruppen omfattende polysorbater, såsom polysorbat 20, 40, 60, 80 og pluronisk F68.
4. Fremgangsmåde ifølge krav 1, 2 eller 3 kendetegnet ved, at der anvendes en vaske-buffer til capto MMC™-harpiksen, til bortvaskning af kontaminanter og tilbageholde rhG-CSF, før frigivelsen af rhG-CSF, kendetegnet ved , at vaskebufferen omfatter en aminosyre med en basisk sidekæde og/eller et salt udvalgt ifølge Hofmeister-serier.
5. Fremgangsmåde ifølge krav 1, 2, 3 eller 4 omfattende følgende fremgangsmådetrin: - capto MMC™-kromatografi; - et inaktiveringsfremgangsmådetrin på kemisk basis for indkapslede viri; - en affinitets-harpiks baseret på et Fab-fragment rettet mod rhG-CSF expressio-neret i gær; - en kation-udveksler, såsom SP-sepharose eller resource S; - et patogent filtrerings-fjernelsestrin med en middelporestørrelse med en størrelse, der andrager 20nm, såsom planova 20N; - et bufferudvekslings- og/eller koncentrerende fremgangsmådetrin, såsom ultrafiltrering med en tilnærmelsesvis afskæring andragende 1-5 kDa; - en størrelse-ekskluderings-kromatografi-harpiks, såsom superdex 75.
6. Fremgangsmåde ifølge krav 5 kendetegnet ved , at capto MMC™-kromatografitrinnet er kombineret med et affinitets-kromatografitrin, hvor affiniteten er tilvejebragt ved hjælp af et gær-afledt Fab-fragment rettet mod rhG-CSF, og at renheden af det fra affinitets-kromatografi-harpiksen resulterende produkt er højere end 90 %.
7. Fremgangsmåde ifølge krav 6 kendetegnet ved , at et eller flere yderligere trin med kromatografi finder udøvelse udvalgt blandt størrelses-eksklusion, an-ion-udveksling, kation-udveksling, hydrofobisk interaktion (udveksling) og immobili-seret metal-affinitets-kromatografi, kendetegnet ved, at renheden af slutproduktet er højere end 99 %.
8. Fremgangsmåde ifølge krav 1, 2, 3, 4, 5, 6 eller 7 kendetegnet ved, at renselsessekvensen endvidere omfatter pathogenfjemelses-/pathogeninaktiverings-fremgangsmådetrin omfattende et kemisk baseret inaktiverings-fremgangsmådetrin, et fjemelses-fremgangsmådetrin på størrelsesbasis, kromatografi-fremgangsmådetrin eller kombinationer deraf, hvor fremgangsmådetrinene er baseret på forskellige fysiologiske egenskaber rettet mod pathogenet, der skal fjernes.
DK16156518.9T 2010-03-30 2011-03-30 Fremgangsmåde til rensning af granulocyt-kolonistimulerende faktor, g-csf DK3040346T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10158522 2010-03-30
US28289410P 2010-04-16 2010-04-16
EP11711340.7A EP2552948B1 (en) 2010-03-30 2011-03-30 Process for the purification of growth factor protein g-csf

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DK3040346T3 true DK3040346T3 (da) 2018-06-14

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DK11711340.7T DK2552948T3 (da) 2010-03-30 2011-03-30 Fremgangsmåde til rensning af vækstfaktorprotein G-CSF
DK16156518.9T DK3040346T3 (da) 2010-03-30 2011-03-30 Fremgangsmåde til rensning af granulocyt-kolonistimulerende faktor, g-csf

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US (2) US9453045B2 (da)
EP (2) EP3040346B1 (da)
JP (2) JP5948315B2 (da)
KR (1) KR101951446B1 (da)
CN (2) CN105859870A (da)
AU (1) AU2011234532B2 (da)
BR (1) BR112012024956A2 (da)
CA (1) CA2793143C (da)
DK (2) DK2552948T3 (da)
ES (2) ES2670827T3 (da)
IL (1) IL221652B (da)
MX (1) MX2012011065A (da)
RU (2) RU2571926C2 (da)
TR (1) TR201807352T4 (da)
WO (1) WO2011121031A1 (da)
ZA (1) ZA201207228B (da)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2027875A1 (en) * 2007-08-23 2009-02-25 Octapharma AG A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC)
US9453045B2 (en) * 2010-03-30 2016-09-27 Octapharma Ag Process for the purification of a growth factor protein
US9422354B2 (en) * 2012-06-19 2016-08-23 Indian Institute Of Technology Delhi Process for purification of recombinant granulocyte colony stimulating factor (rHu GCSF)
US20150275195A1 (en) 2012-10-24 2015-10-01 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
CN102994514B (zh) * 2012-11-07 2015-06-10 武汉禾元生物科技股份有限公司 一种从水稻种子生产和分离纯化重组人抗胰蛋白酶(OsrAAT)的方法
PL3461891T3 (pl) * 2014-01-24 2020-11-16 Am-Pharma B.V. Przetwarzanie końcowe fosfatazy alkalicznej
US20180346510A1 (en) * 2015-11-18 2018-12-06 Merck Patent Gmbh Opposite ph-salt gradients for improved protein separations
AU2016355739A1 (en) * 2015-11-18 2018-07-05 Merck Patent Gmbh Improved protein separation in ion exchange chromatography
CN111344301A (zh) * 2017-11-14 2020-06-26 生物资源公司 抗体纯化
KR101884793B1 (ko) 2017-11-23 2018-08-02 강원대학교산학협력단 Cage 단백질의 생산 및 정제 방법
CN109206476B (zh) * 2018-11-20 2021-08-17 中国科学院青岛生物能源与过程研究所 一种蛋白分离纯化的方法
WO2020234742A1 (en) 2019-05-20 2020-11-26 Lupin Limited Granulocyte colony stimulating factor purification
JP2022547309A (ja) 2019-09-10 2022-11-11 ピアス・バイオテクノロジー・インコーポレイテッド サンプル調製組成物、デバイス、システムおよび方法
CN111825757A (zh) * 2020-08-04 2020-10-27 沈阳何氏眼产业集团有限公司 去除重组il-18中热源的方法及制得的产品

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
US5714583A (en) 1995-06-07 1998-02-03 Genetics Institute, Inc. Factor IX purification methods
JP4638035B2 (ja) 1998-08-28 2011-02-23 ジェネンテック， インコーポレイテッド ヒト抗−ＩＸ／ＩＸａ因子抗体
SI21102A (sl) * 2001-12-19 2003-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Postopek za izolacijo biološko aktivnega granulocitne kolonije stimulirajočega dejavnika
WO2005082483A1 (en) 2004-02-27 2005-09-09 Ge Healthcare Bio-Sciences Ab A process for the purification of antibodies
US9624260B2 (en) 2004-06-07 2017-04-18 Therapure Biopharma Inc. Process for isolation of plasma or serum proteins
EP1707634A1 (en) 2005-03-29 2006-10-04 Octapharma AG Method for isolation of recombinantly produced proteins
WO2006128497A1 (en) 2005-06-01 2006-12-07 Novo Nordisk A/S Pharmaceutical formulation of factor xi
EP1739179A1 (en) 2005-06-30 2007-01-03 Octapharma AG Serum-free stable transfection and production of recombinant human proteins in human cell lines
WO2008073620A2 (en) 2006-11-02 2008-06-19 Neose Technologies, Inc. Manufacturing process for the production of polypeptides expressed in insect cell-lines
US20100062512A1 (en) 2007-01-04 2010-03-11 Crucell Holland B.V. Purification of factor xi
DE602008005885D1 (de) 2007-07-11 2011-05-12 Novo Nordisk As Aufreinigung von faktor viii unter verwendung eine
EP2027875A1 (en) 2007-08-23 2009-02-25 Octapharma AG A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC)
US7957922B2 (en) * 2007-08-27 2011-06-07 Fred Wu Data logger system
CA2699790A1 (en) * 2007-09-10 2009-03-19 Rentech, Inc. Hydrogen and carbon utilization in synthetic fuels production plants
WO2009063069A2 (en) * 2007-11-15 2009-05-22 Novo Nordisk A/S Endotoxin removal
CN101260145B (zh) 2008-04-11 2012-08-08 天津溥瀛生物技术有限公司 一种重组人血清白蛋白及其融合蛋白的分离纯化工艺
WO2009156430A1 (en) * 2008-06-24 2009-12-30 Octapharma Ag A process of purifying coagulation factor viii
US9453045B2 (en) * 2010-03-30 2016-09-27 Octapharma Ag Process for the purification of a growth factor protein

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Publication number Publication date
RU2015149979A3 (da) 2019-07-17
AU2011234532A1 (en) 2012-09-20
RU2012146074A (ru) 2014-05-10
TR201807352T4 (tr) 2018-06-21
CA2793143A1 (en) 2011-10-06
RU2015149979A (ru) 2019-01-15
AU2011234532B2 (en) 2015-04-09
RU2571926C2 (ru) 2015-12-27
BR112012024956A2 (pt) 2016-07-12
EP3040346A1 (en) 2016-07-06
DK2552948T3 (da) 2016-10-17
US20130096279A1 (en) 2013-04-18
EP3040346B1 (en) 2018-02-28
EP2552948A1 (en) 2013-02-06
ES2670827T3 (es) 2018-06-01
JP5948315B2 (ja) 2016-07-06
KR20130010897A (ko) 2013-01-29
WO2011121031A1 (en) 2011-10-06
MX2012011065A (es) 2012-10-10
CN102858797A (zh) 2013-01-02
ES2596727T3 (es) 2017-01-11
CN102858797B (zh) 2016-05-11
JP2016190856A (ja) 2016-11-10
US9453045B2 (en) 2016-09-27
KR101951446B1 (ko) 2019-02-22
US20170051028A1 (en) 2017-02-23
CA2793143C (en) 2020-04-28
EP2552948B1 (en) 2016-07-13
JP2013523690A (ja) 2013-06-17
CN105859870A (zh) 2016-08-17
IL221652B (en) 2018-08-30
ZA201207228B (en) 2013-06-26
US10214575B2 (en) 2019-02-26

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