BR0214568A - Purificação cromatográfica de eritropoietina humana recombinante - Google Patents

Purificação cromatográfica de eritropoietina humana recombinante

Info

Publication number
BR0214568A
BR0214568A BR0214568-5A BR0214568A BR0214568A BR 0214568 A BR0214568 A BR 0214568A BR 0214568 A BR0214568 A BR 0214568A BR 0214568 A BR0214568 A BR 0214568A
Authority
BR
Brazil
Prior art keywords
rhepo
column
recombinant human
supernatant
culture medium
Prior art date
Application number
BR0214568-5A
Other languages
English (en)
Inventor
Peter Alliger
Norbert Palma
Original Assignee
Sandoz Ag
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 Sandoz Ag filed Critical Sandoz Ag
Publication of BR0214568A publication Critical patent/BR0214568A/pt

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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
    • C07K1/16—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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
    • 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
    • C07K14/505—Erythropoietin [EPO]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Landscapes

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

Abstract

"PURIFICAçãO CROMATOGRáFICA DE ERITROPOIETINA HUMANA RECOMBINANTE". A invenção fornece um método para restabelecer e purificar eritropoietina humana recombinante (rhEpo) de um meio de cultura celular compreendendo células hospedeiras cujo método compreende as etapas de: (a) remover as células hospedeiras, constituintes celulares e restos do meio de cultura celular através de centrifugação usando um separador de pilha de disco seguido por uma etapa de filtração de profundidade para obter um sobrenadante do meio de cultura clarificado; (b) ajustar a condutividade do sobrenadante para 5 mS/cm ou menos, e um pH dentre cerca de 7,0 e 8,0; (c) aplicar o sobrenadante da etapa (b) a uma coluna compreendendo um meio cromatográfico de troca aniónica, lavar a coluna, eluir a rhEpo da coluna e colher a(s) fração(ões) de pico que contêm rhEpo; (d) submeter as frações de pico combinadas da etapa (c) a uma etapa de cromatografia de fase reversa usando uma resina de poliestireno que pode ser operada sob pressão média (< 10 bar) e é resistente às concentrações altas de NaOH, como Source 30RPC, a rhEpo sendo eluída usando um gradiente linear de um solvente orgânico; (e) aplicar uma ou maís frações eluídas na etapa (d) que contêm rhEpo a uma coluna compreendendo meios cromatográficos de troca aniónica Q-Seph HP, lavar a coluna e eluir a rhEpo usando um gradiente de sal linear; (f) selecionar uma ou mais frações eluídas na etapa (e) que contêm rhEpo com base no grau de sialilação da rHepo; e (g) submeter uma ou mais frações eluídas na etapa (f) que contêm rhEpo a uma ou mais etapas cromatográficas de exclusão de tamanho usando Superdex 75 "prep grade" para remover os dímeros potenciais e agregados mais altos; e colher o eluato contendo rhEpo.
BR0214568-5A 2001-11-28 2002-11-26 Purificação cromatográfica de eritropoietina humana recombinante BR0214568A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US33383901P 2001-11-28 2001-11-28
PCT/EP2002/013299 WO2003045996A1 (en) 2001-11-28 2002-11-26 Chromatographic purification of recombinant human erythropoietin

Publications (1)

Publication Number Publication Date
BR0214568A true BR0214568A (pt) 2004-11-03

Family

ID=23304479

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0214568-5A BR0214568A (pt) 2001-11-28 2002-11-26 Purificação cromatográfica de eritropoietina humana recombinante

Country Status (20)

Country Link
US (1) US20060099674A1 (pt)
EP (1) EP1453857B1 (pt)
JP (1) JP4293908B2 (pt)
KR (1) KR20040065567A (pt)
CN (1) CN1596268A (pt)
AU (1) AU2002356733A1 (pt)
BR (1) BR0214568A (pt)
CA (1) CA2466627A1 (pt)
ES (1) ES2525945T3 (pt)
HR (1) HRP20040476A2 (pt)
HU (1) HUP0500061A2 (pt)
IL (1) IL161855A0 (pt)
MX (1) MXPA04005189A (pt)
NO (1) NO20042185L (pt)
NZ (1) NZ533083A (pt)
PL (1) PL368755A1 (pt)
RU (1) RU2004119818A (pt)
SI (1) SI1453857T1 (pt)
WO (1) WO2003045996A1 (pt)
ZA (1) ZA200403461B (pt)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003080852A1 (en) * 2002-03-26 2003-10-02 Lek Pharmaceutical And Chemical Company D.D. Process for the preparation of a desired erythropoietin glyco-isoform profile
DE60228460D1 (de) * 2002-12-13 2008-10-02 Bioceuticals Arzneimittel Ag Verfahren zur Herstellung und Reinigung von Erythropoietin
US7157276B2 (en) * 2003-06-20 2007-01-02 Biogen Idec Inc. Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
KR100567448B1 (ko) * 2003-11-05 2006-04-04 주식회사 인투젠 형질전환 동물의 유즙 전처리방법 및 이를 통한 인체단백질의 정제방법
DE102004027816A1 (de) 2004-06-08 2006-01-05 Bioceuticals Arzneimittel Ag Verfahren zur Reinigung von Erythropoietin
WO2006003926A1 (ja) * 2004-06-30 2006-01-12 Terumo Kabushiki Kaisha ウィルス不活化ヘモグロビンおよびその製造方法
US7531632B2 (en) * 2006-02-16 2009-05-12 Gtc Biotherapeutics, Inc. Clarification of transgenic milk using depth filtration
KR100988706B1 (ko) * 2007-03-07 2010-10-18 한미홀딩스 주식회사 재조합 에리트로포이에틴의 신규한 정제방법
KR100900033B1 (ko) * 2007-11-21 2009-06-01 한국생명공학연구원 인간 에리스로포이에틴의 정제방법
DE102008002209A1 (de) 2008-06-04 2009-12-10 Evonik Degussa Gmbh Verfahren zur Aufreinigung von Erythropoietin
US8779110B2 (en) 2008-06-24 2014-07-15 Dr. Reddy's Laboratories Limited Purification of low isoelectric point isoforms of darbepoietin
CA2739392A1 (en) * 2008-10-17 2010-04-22 Percivia Llc Clarification process
DE102008054716A1 (de) * 2008-12-16 2010-06-17 Evonik Degussa Gmbh Inprozesskontrolle in einem Verfahren zur Herstellung von EPO
JP5728016B2 (ja) 2009-09-23 2015-06-03 ラチオファーマ ゲーエムベーハー 組換えヒトエリスロポエチン（ｅｐｏ）を精製するためのプロセス、このようにして精製されたｅｐｏおよびこれを含む医薬組成物
WO2011063195A2 (en) * 2009-11-20 2011-05-26 Dr. Reddy's Laboratories Ltd. Purification of modified cytokines
CN102453087B (zh) * 2010-10-22 2013-12-25 广东赛保尔生物医药技术有限公司 一种单取代peg-epo的纯化及制备方法
AU2011329053A1 (en) * 2010-11-15 2013-06-06 Biogen Inc. Enrichment and concentration of select product isoforms by overloaded bind and elute chromatography
WO2012069474A2 (en) * 2010-11-24 2012-05-31 H. Lundbeck A/S A method for reducing potential virus burden in a sample by cyanate treatment
KR101443257B1 (ko) 2011-10-18 2014-09-19 주식회사 종근당 낮은 등전점을 갖는 에리스로포이에틴 유사체의 정제방법
WO2014138921A1 (en) * 2013-03-15 2014-09-18 Apotex Inc. Enhanced liquid formulation stability of erythropoietin alpha through purification processing
CN105358228A (zh) 2013-07-05 2016-02-24 法国血液分割暨生化制品实验室 亲和层析基质
KR101414897B1 (ko) 2013-11-29 2014-07-04 씨제이헬스케어 주식회사 다베포에틴 알파의 정제 방법
WO2015134640A1 (en) * 2014-03-05 2015-09-11 GlycoScientific LLC Isotopically labeled glycans and methods for producing the same
CA2970732C (en) 2014-12-15 2023-05-16 Merck Patent Gmbh Target molecule capture from crude solutions
EP3153522A1 (en) 2015-10-09 2017-04-12 Hetero Drugs Limited Process for the purification of erythropoietin and darbepoetin alfa
CN106770597A (zh) * 2017-03-01 2017-05-31 上海博威生物医药有限公司 用于检测组合物中促红细胞生成素电荷异质体的cze检测方法
CN112940101A (zh) * 2019-12-11 2021-06-11 深圳赛保尔生物药业有限公司 重组人促红细胞生成素的纯化方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4677195A (en) * 1985-01-11 1987-06-30 Genetics Institute, Inc. Method for the purification of erythropoietin and erythropoietin compositions
US5856298A (en) * 1989-10-13 1999-01-05 Amgen Inc. Erythropoietin isoforms
DE69130990T2 (de) * 1990-02-20 1999-12-02 Baxter Int Gereinigtes, virusfreies menschliches Thrombin
DE19504211A1 (de) * 1995-02-09 1996-08-14 Behringwerke Ag Entfernen von Viren durch Ultrafiltration aus Proteinlösungen
TW442492B (en) 1995-07-26 2001-06-23 Novartis Ag Process for the enrichment of interferon
PT889949E (pt) * 1996-03-13 2003-10-31 Delta Biotechnology Ltd Controlo de fermentacao
BR9917606A (pt) 1998-11-06 2002-12-31 Bio Sidus S A Procedimento para a purificação de eritropoetina humana recombinante a partir de sobrenadantes de cultivo de células e eritropoetina humana recombinante obtida com tal procedimento

Also Published As

Publication number Publication date
CA2466627A1 (en) 2003-06-05
NO20042185L (no) 2004-08-23
SI1453857T1 (sl) 2015-01-30
EP1453857B1 (en) 2014-08-13
US20060099674A1 (en) 2006-05-11
PL368755A1 (en) 2005-04-04
IL161855A0 (en) 2005-11-20
EP1453857A1 (en) 2004-09-08
RU2004119818A (ru) 2006-01-10
HUP0500061A2 (hu) 2005-04-28
KR20040065567A (ko) 2004-07-22
NZ533083A (en) 2006-09-29
HRP20040476A2 (en) 2005-10-31
WO2003045996A1 (en) 2003-06-05
AU2002356733A1 (en) 2003-06-10
MXPA04005189A (es) 2005-02-17
ZA200403461B (en) 2006-05-31
ES2525945T3 (es) 2015-01-02
JP2005518196A (ja) 2005-06-23
CN1596268A (zh) 2005-03-16
JP4293908B2 (ja) 2009-07-08

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Legal Events

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B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

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B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO PUBLICADO NA RPI 2064 DE 27/07/2010.