WO2009133529A3 - Processes for refolding of insulin - Google Patents

Processes for refolding of insulin Download PDF

Info

Publication number
WO2009133529A3
WO2009133529A3 PCT/IB2009/051763 IB2009051763W WO2009133529A3 WO 2009133529 A3 WO2009133529 A3 WO 2009133529A3 IB 2009051763 W IB2009051763 W IB 2009051763W WO 2009133529 A3 WO2009133529 A3 WO 2009133529A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
precursor
solubilized
refolded
derivatives
Prior art date
Application number
PCT/IB2009/051763
Other languages
French (fr)
Other versions
WO2009133529A2 (en
Inventor
Raju Edupuganti B
Haseeb Jagirdar
Manish Kumar
Jayaraman Parthipan
Vivek Yadav
Maharaj K Sahib
Original Assignee
Wockhardt Research Centre
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 Wockhardt Research Centre filed Critical Wockhardt Research Centre
Priority to ES09738542.1T priority Critical patent/ES2522627T3/en
Priority to EP09738542.1A priority patent/EP2274318B1/en
Priority to JP2011506820A priority patent/JP5677938B2/en
Priority to US12/990,352 priority patent/US9296806B2/en
Priority to CA2724510A priority patent/CA2724510C/en
Publication of WO2009133529A2 publication Critical patent/WO2009133529A2/en
Publication of WO2009133529A3 publication Critical patent/WO2009133529A3/en
Priority to ZA2010/07911A priority patent/ZA201007911B/en

Links

Classifications

    • 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
    • C07K14/62—Insulins

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The invention provides processes for obtaining a precursor for insulin, analogs or derivatives thereof having correctly bonded cystine bridges. The process involves solubilizing a precursor of insulin, insulin analog or derivatives in an aqueous solution or a buffer containing cysteine or cysteine hydrochloride and one or more of chaotropic auxiliary. The solubilized precursors are refolded by adding diluent to the solubilized mixture (reverse dilution). Further, the solubilized precursors, wherein the concentration of precursor in reaction mixture is more than 0.65g/litre can also be refolded by diluting the reaction mixture with a diluent optionally comprising about 5-40 % v/v of one or more of alcoholic or aprotic solvents.
PCT/IB2009/051763 2008-04-30 2009-04-30 Processes for refolding of insulin WO2009133529A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
ES09738542.1T ES2522627T3 (en) 2008-04-30 2009-04-30 Procedures for insulin refolding
EP09738542.1A EP2274318B1 (en) 2008-04-30 2009-04-30 Processes for refolding of insulin
JP2011506820A JP5677938B2 (en) 2008-04-30 2009-04-30 How to refold insulin
US12/990,352 US9296806B2 (en) 2008-04-30 2009-04-30 Processes for refolding of insulin
CA2724510A CA2724510C (en) 2008-04-30 2009-04-30 Processes for refolding of insulin
ZA2010/07911A ZA201007911B (en) 2008-04-30 2010-11-04 Processes for refolding of insulin

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
IN955MU2008 2008-04-30
IN954/MUM/2008 2008-04-30
IN955/MUM/2008 2008-04-30
IN954MU2008 2008-04-30
IN1518MU2008 2008-07-18
IN1518/MUM/2008 2008-07-18

Publications (2)

Publication Number Publication Date
WO2009133529A2 WO2009133529A2 (en) 2009-11-05
WO2009133529A3 true WO2009133529A3 (en) 2010-01-07

Family

ID=41227173

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/051763 WO2009133529A2 (en) 2008-04-30 2009-04-30 Processes for refolding of insulin

Country Status (7)

Country Link
US (1) US9296806B2 (en)
EP (1) EP2274318B1 (en)
JP (1) JP5677938B2 (en)
CA (1) CA2724510C (en)
ES (1) ES2522627T3 (en)
WO (1) WO2009133529A2 (en)
ZA (1) ZA201007911B (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2739646T3 (en) * 2011-05-10 2018-05-30 Stefan Hermann Comprehensive buffer system for renaturing human proinsulin or proinsulin derivatives
JP6431844B2 (en) * 2012-10-26 2018-11-28 ルピン アトランティス ホールディングス エスエーＬｕｐｉｎ Ａｔｌａｎｔｉｓ Ｈｏｌｄｉｎｇｓ Ｓａ Stable pharmaceutical composition of TNFR: FC fusion protein
NZ707160A (en) * 2012-12-19 2016-08-26 Wockhardt Ltd A stable aqueous composition comprising human insulin or an analogue or derivative thereof
CN103694339B (en) * 2013-12-04 2017-10-13 珠海联邦制药股份有限公司 A kind of refolding method of insulin glargine precursor
EP3344651B1 (en) * 2015-09-02 2022-03-02 Merck Sharp & Dohme Corp. A process for obtaining insulin with correctly formed disulfide bonds
KR20200080747A (en) * 2018-12-27 2020-07-07 주식회사 폴루스 An Enzymatic Conversion Composition for Producing Insulin from Proinsulin and a Method for Producing Insulin from Proinsulin Using the Same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2141531C1 (en) * 1999-05-26 1999-11-20 Российское акционерное общество открытого типа "Биопрепарат" Method of recombinant human insulin preparing
US6380355B1 (en) * 1997-08-18 2002-04-30 Aventis Pharma Deutschland Gmbh Process for obtaining insulin precursors having correctly bonded cystine bridges

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE59305396D1 (en) * 1992-12-02 1997-03-20 Hoechst Ag Process for obtaining proinsulin with correctly connected cystine bridges
DE4405179A1 (en) * 1994-02-18 1995-08-24 Hoechst Ag Method of obtaining insulin with correctly connected cystine bridges
JP2001048898A (en) * 1999-08-11 2001-02-20 Itoham Foods Inc Production of polypeptide having correctly linked disulfide bond
DE102004015965A1 (en) * 2004-04-01 2005-10-20 Aventis Pharma Gmbh Process for recovering insulins by improved air aeration of the fold

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6380355B1 (en) * 1997-08-18 2002-04-30 Aventis Pharma Deutschland Gmbh Process for obtaining insulin precursors having correctly bonded cystine bridges
RU2141531C1 (en) * 1999-05-26 1999-11-20 Российское акционерное общество открытого типа "Биопрепарат" Method of recombinant human insulin preparing

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
WINTER JEANNETTE ET AL: "Renaturation of human proinsulin: A study on refolding and conversion to insulin.", ANALYTICAL BIOCHEMISTRY, vol. 310, no. 2, 1 November 2002 (2002-11-01), pages 148 - 155, XP002553985, ISSN: 0003-2697 *

Also Published As

Publication number Publication date
ES2522627T3 (en) 2014-11-17
US9296806B2 (en) 2016-03-29
JP2011519369A (en) 2011-07-07
ZA201007911B (en) 2012-02-29
EP2274318A2 (en) 2011-01-19
EP2274318B1 (en) 2014-08-13
WO2009133529A2 (en) 2009-11-05
JP5677938B2 (en) 2015-02-25
CA2724510A1 (en) 2009-11-05
CA2724510C (en) 2015-10-27
US20110152507A1 (en) 2011-06-23

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