HUP0101988A2 - Eljárás intravénás beadásra alkalmas immunglobulinok és más immunglobulin termékek előállítására - Google Patents

Eljárás intravénás beadásra alkalmas immunglobulinok és más immunglobulin termékek előállítására

Info

Publication number
HUP0101988A2
HUP0101988A2 HU0101988A HUP0101988A HUP0101988A2 HU P0101988 A2 HUP0101988 A2 HU P0101988A2 HU 0101988 A HU0101988 A HU 0101988A HU P0101988 A HUP0101988 A HU P0101988A HU P0101988 A2 HUP0101988 A2 HU P0101988A2
Authority
HU
Hungary
Prior art keywords
immunoglobulin
intravenous administration
product
purification
igg
Prior art date
Application number
HU0101988A
Other languages
English (en)
Inventor
Inga Laursen
Borge Teisner
Original Assignee
Statens Serum Institut
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26150417&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HUP0101988(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Statens Serum Institut filed Critical Statens Serum Institut
Publication of HUP0101988A2 publication Critical patent/HUP0101988A2/hu
Publication of HUP0101988A3 publication Critical patent/HUP0101988A3/hu
Publication of HU228076B1 publication Critical patent/HU228076B1/hu

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A találmány immunglobulin G (IgG) nyers plazmafehérje-frakcióból valótisztítási eljárására vonatkozik. Az eljárás számos lépésből áll, és alépések közül az anion- és kationcserélő kromatográfiás tisztítástelőnyösen sorba kapcsolt oszlopokon végezik. A tisztítási eljárássorán előnyösen 5,0-6,0 pH-értékű és 5-25 mM molaritású acetátpufferthasználtak. A találmány oltalmi körébe tartozik a találmány szerintieljárással előállított immunglobulin termék is. A találmány olyanimmunglobulin termékre vonatkozik, melynek tisztasága 98%-nál nagyobb,az IgG monomer- és dimertartalma 98,5%-nál nagyobb, az IgA-tartalma 4mg IgA/1-nél kisebb és 0,5%-nál kisebb mennyiségben tartalmazpolimereket és aggregátumokat. Az említett termék stabilizálószerkéntnem tartalmaz detergenst, PEG-t vagy albumint. A termék stabil, vírus-biztos, folyékony és közvetlen intravénás beadásra alkalmas. Ó
HU0101988A 1998-06-09 1999-06-09 Process for producing immunoglobulins for intravenous administration and other immunoglobulin products HU228076B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP98201909 1998-06-09
US10205598P 1998-09-28 1998-09-28
PCT/DK1999/000312 WO1999064462A1 (en) 1998-06-09 1999-06-09 Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

Publications (3)

Publication Number Publication Date
HUP0101988A2 true HUP0101988A2 (hu) 2001-09-28
HUP0101988A3 HUP0101988A3 (en) 2004-10-28
HU228076B1 HU228076B1 (en) 2012-10-29

Family

ID=26150417

Family Applications (1)

Application Number Title Priority Date Filing Date
HU0101988A HU228076B1 (en) 1998-06-09 1999-06-09 Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

Country Status (23)

Country Link
EP (4) EP1493751A1 (hu)
JP (1) JP5478519B2 (hu)
KR (1) KR100501263B1 (hu)
CN (1) CN1196714C (hu)
AT (1) ATE277950T1 (hu)
AU (1) AU753468B2 (hu)
BR (1) BR9911131A (hu)
CA (1) CA2330170C (hu)
CZ (1) CZ297199B6 (hu)
DE (1) DE69920693T2 (hu)
DK (1) DK1084147T3 (hu)
ES (1) ES2229784T3 (hu)
HK (2) HK1151044A1 (hu)
HU (1) HU228076B1 (hu)
ID (1) ID27417A (hu)
IL (1) IL140155A (hu)
NZ (1) NZ509135A (hu)
PL (1) PL196770B1 (hu)
PT (1) PT1084147E (hu)
RU (1) RU2197500C2 (hu)
SK (1) SK288128B6 (hu)
TR (1) TR200100303T2 (hu)
WO (1) WO1999064462A1 (hu)

Families Citing this family (70)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2158776B1 (es) * 1999-04-13 2002-03-16 Apc Europ S A Procedimiento para la obtencion de gammaglobulinas de origen animal y aplicaciones correspondientes.
AUPQ026799A0 (en) * 1999-05-10 1999-06-03 Csl Limited Method of increasing protein stability by removing immunoglobulin aggregates
EP1267905B1 (en) * 2000-03-10 2005-09-28 Medinnova As Composition for the treatment of heart failure
SE0001128D0 (sv) * 2000-03-30 2000-03-30 Amersham Pharm Biotech Ab A method of producing IgG
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
FR2824568B1 (fr) 2001-05-11 2004-04-09 Lab Francais Du Fractionnement Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique
US20030223985A1 (en) * 2002-05-29 2003-12-04 The Lauridsen Group. Incorporated Globulin protein to lower cholesterol in humans
EP2261230B1 (en) 2002-09-11 2017-05-10 Chugai Seiyaku Kabushiki Kaisha Protein purification method
EP1614693A4 (en) * 2003-03-31 2006-07-19 Kirin Brewery PURIFICATION OF A HUMAN MONOCLONAL ANTIBODY AND A HUMAN POLYCLONAL ANTIBODY
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
MXPA06008435A (es) * 2004-01-30 2007-05-23 Suomen Punainen Risti Veripalvelu Proceso de manufactura de una inmunoglobulina libre de virus.
AU2005209360B2 (en) 2004-01-30 2009-06-25 Takeda Pharmaceutical Company Limited Production and purification of recombinant arylsulfatase A
AU2005229674B2 (en) * 2004-11-18 2010-11-04 Kedrion Melville Inc. Low concentration solvent/detergent process of immuneglobulin with pre-treatment
TWI391399B (zh) 2005-05-25 2013-04-01 Hoffmann La Roche 測定溶離多肽之鹽濃度之方法
GB2430883B (en) 2005-09-30 2008-03-19 Cambridge Antibody Tech Interleukin-13 antibody composition
US9309316B2 (en) 2005-12-20 2016-04-12 Bristol-Myers Squibb Company Stable subcutaneous protein formulations and uses thereof
FR2895263B1 (fr) 2005-12-26 2008-05-30 Lab Francais Du Fractionnement Concentre d'immunoglobines g (lg) appauvri en anticorps anti-a et anti-b, et en igg polyreactives
DK2628746T3 (en) * 2006-04-04 2019-04-01 Chiesi Farm Spa A method for the concentration of a polypeptide
RU2303995C1 (ru) * 2006-04-28 2007-08-10 Халлар Абдумуслимович Алиханов Средство, обладающее иммунорегуляторным свойством и его применение для лечения аутоиммунных заболеваний
WO2008025748A1 (en) 2006-08-28 2008-03-06 Ares Trading S.A. Process for the purification of fc-containing proteins
DE102007001521A1 (de) * 2007-01-10 2008-07-17 Matthias, Torsten, Dr. Verwendung von Cohn-Oncley-Fraktionen II und II/III zur Behandlung des systemischen Lupus erythematodes
DK2215117T4 (en) 2007-10-30 2018-04-09 Genentech Inc ANTISTO PURIFICATION BY CATION CHANGE CHROMATOGRAPHY
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8772461B2 (en) 2008-04-15 2014-07-08 Grifols Therapeutics Inc. Two-stage ultrafiltration/diafiltration
FR2939667B1 (fr) 2008-12-17 2012-01-27 Fractionnement Et Des Biotechonologies Lab Franc Composition d'immunoglobine g comme medicament pour le traitement de l'ictere neonatal par incompatibilite foetomaternelle dans le systeme abo
MY157239A (en) 2009-05-27 2016-05-13 Baxalta Inc A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
US20130116413A1 (en) * 2009-12-29 2013-05-09 Dr. Reddy's Laboratories, Inc. Purification of proteins
AU2011212440B2 (en) 2010-02-04 2015-01-22 Csl Behring Ag Immunoglobulin preparation
EP2361636A1 (en) * 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
GB201006753D0 (en) 2010-04-22 2010-06-09 Biotest Ag Process for preparing an immunolobulin composition
RU2467783C2 (ru) * 2010-07-30 2012-11-27 Закрытое акционерное общество "БиоХимМак СТ" Способ хроматографического выделения иммуноглобулина
SG191781A1 (en) 2010-12-30 2013-08-30 Lab Francais Du Fractionnement Glycols as pathogen inactivating agents
ES2865449T3 (es) 2011-03-16 2021-10-15 Hoffmann La Roche Cromatografía de intercambio iónico con selectividad mejorada para la separación de monómeros, agregados y fragmentos polipeptídicos por modulación de la fase móvil
FR2974301B1 (fr) 2011-04-20 2013-08-23 Lab Francais Du Fractionnement Procede de preparation d'un produit plasmatique deplete en un ou plusieurs facteurs thrombogenes
IL212911A0 (en) * 2011-05-16 2011-07-31 Omrix Biopharmaceuticals Ltd Immunoglobulin reduced in thrombogenic contaminants and preparation thereof
ES2625511T3 (es) 2011-07-08 2017-07-19 Shire Human Genetic Therapies, Inc. Métodos para la purificación de arylsulfatasa A
MX349005B (es) * 2011-08-26 2017-07-06 Baxalta Inc Metodo para reducir el potencial tromboembolico de una composicion de inmunoglobulina derivada de plasma.
CN102532307B (zh) * 2012-02-22 2013-06-12 成都蓉生药业有限责任公司 一种制备人免疫球蛋白的方法
MX369444B (es) 2012-02-29 2019-11-08 Baxalta Inc REMIELINIZACION DE NERVIOS PERIFERICOS ESTIMULADA POR IgG.
JP2015510875A (ja) 2012-03-09 2015-04-13 ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト 分泌様免疫グロブリンを含む組成物
EP2636681A1 (en) 2012-03-09 2013-09-11 CSL Behring AG Process for enriching IgA
EP2636684A1 (en) 2012-03-09 2013-09-11 CSL Behring AG Prevention of infection
ES2381828B1 (es) * 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO
KR102065355B1 (ko) * 2012-05-31 2020-01-13 에이전시 포 사이언스, 테크놀로지 앤드 리서치 단백질 제조물 내의 응집체 양 감소를 위한 혼합 다관능 표면들의 사용 방법
JP6297029B2 (ja) 2012-05-31 2018-03-20 エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ 多様な官能基を有する粒子による免疫グロブリンg調製物のクロマトグラフィー精製
EP2682168A1 (en) 2012-07-02 2014-01-08 Millipore Corporation Purification of biological molecules
MX2015008875A (es) 2013-01-09 2015-10-22 Shire Human Genetic Therapies Metodos para la purificacion de arilsulfatasa a.
AU2013203043B2 (en) 2013-03-15 2016-10-06 Takeda Pharmaceutical Company Limited Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs
WO2014186310A1 (en) 2013-05-13 2014-11-20 Momenta Pharmaceuticals, Inc. Methods for the treatment of neurodegeneration
DK3016976T3 (da) 2013-07-01 2020-12-07 Csl Behring Ag Proces
AU2014285971A1 (en) 2013-07-05 2016-02-04 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Affinity chromatography matrix
WO2015057622A1 (en) 2013-10-16 2015-04-23 Momenta Pharmaceuticals, Inc. Sialylated glycoproteins
CN103665100A (zh) * 2014-01-03 2014-03-26 华兰生物工程重庆有限公司 低温乙醇提取静注人免疫球蛋白的方法
KR101917196B1 (ko) 2014-03-11 2018-11-09 주식회사 녹십자홀딩스 면역글로불린의 정제방법
FR3018450B1 (fr) 2014-03-11 2016-04-15 Lab Francais Du Fractionnement Procede de preparation de proteines plasmatiques humaines
US10435670B2 (en) * 2014-04-15 2019-10-08 Boehringer Ingelheim International Gmbh Methods, apparatuses, and systems for continuously inactivating a virus during manufacture of a biological product
CN104004090A (zh) * 2014-06-12 2014-08-27 新疆德源生物工程有限公司 一种人免疫球蛋白的制备方法
CN104356231B (zh) * 2014-11-10 2017-08-08 北海开元生物科技有限公司 一种有效去除人免疫球蛋白多聚体的方法
US9556253B2 (en) 2014-12-02 2017-01-31 Hemarus Therapeutics Limited Process for increased yield of immunoglobulin from human plasma
FR3035971A1 (fr) 2015-05-07 2016-11-11 Lab Francais Du Fractionnement Composition enrichie en immunoglobulines polyclonales anti-a et/ou anti-b
KR101657690B1 (ko) * 2015-06-05 2016-09-19 주식회사 녹십자홀딩스 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법
CN105950576A (zh) * 2016-05-26 2016-09-21 成都远睿生物技术有限公司 一种从牛血中提取多种蛋白的方法
CN107880116B (zh) * 2016-09-30 2023-02-03 盖立复集团公司 用于制备免疫球蛋白的方法
FR3064484A1 (fr) 2017-03-31 2018-10-05 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Composition d'immunoglobulines utiles pour traiter des infections virales
FR3064486A1 (fr) 2017-03-31 2018-10-05 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Prevention d'une infection par le virus respiratoire syncytial dans les voies respiratoires superieures
FR3064485A1 (fr) 2017-03-31 2018-10-05 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Traitement d'une infection par le virus respiratoire syncytial
KR20190047376A (ko) 2017-10-27 2019-05-08 주식회사 녹십자 개선된 면역글로불린의 정제방법
CN109776675A (zh) * 2017-11-10 2019-05-21 北京博莱得利生物技术有限责任公司 两步离子交换层析法制备犬免疫球蛋白的方法
CN112574296B (zh) * 2020-12-30 2023-05-19 中国医学科学院输血研究所 一种模拟IVIg的多人份混合人血浆IgG样品的分离纯化方法
KR20230148961A (ko) * 2022-04-19 2023-10-26 에스케이플라즈마 주식회사 면역글로불린 정제방법

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2364792A1 (de) * 1973-01-15 1974-07-18 South African Inventions Verfahren zum reinigen von gammaglobulin
US4296027A (en) * 1977-08-31 1981-10-20 The Regents Of The University Of Minnesota Pure intravenous human and animal gamma globulins
US4314997A (en) 1980-10-06 1982-02-09 Edward Shanbrom Purification of plasma protein products
US4315919A (en) 1980-10-06 1982-02-16 Edward Shanbrom Depyrogenation process
US4764369A (en) 1983-07-14 1988-08-16 New York Blood Center Inc. Undenatured virus-free biologically active protein derivatives
NZ216094A (en) * 1985-05-15 1989-06-28 Commw Serum Lab Commission Method for purification of an immunoglobulin
DE4118912C1 (hu) * 1991-06-08 1992-07-02 Biotest Pharma Gmbh, 6072 Dreieich, De
FR2706466B1 (fr) * 1993-06-14 1995-08-25 Aetsrn Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré.

Also Published As

Publication number Publication date
DE69920693T2 (de) 2005-11-03
CN1311797A (zh) 2001-09-05
CA2330170C (en) 2010-11-02
EP1084147B1 (en) 2004-09-29
IL140155A0 (en) 2002-02-10
JP2011102314A (ja) 2011-05-26
CZ20004534A3 (en) 2001-06-13
TR200100303T2 (tr) 2001-06-21
CA2330170A1 (en) 1999-12-16
EP2272870A1 (en) 2011-01-12
PL344671A1 (en) 2001-11-19
ES2229784T3 (es) 2005-04-16
PT1084147E (pt) 2005-01-31
SK18662000A3 (sk) 2001-07-10
HUP0101988A3 (en) 2004-10-28
KR20010052733A (ko) 2001-06-25
SK288128B6 (sk) 2013-10-02
EP2270044B1 (en) 2014-11-05
DE69920693D1 (de) 2004-11-04
HK1151045A1 (en) 2012-01-20
KR100501263B1 (ko) 2005-07-18
IL140155A (en) 2005-12-18
DK1084147T3 (da) 2004-10-25
RU2197500C2 (ru) 2003-01-27
CZ297199B6 (cs) 2006-09-13
AU753468B2 (en) 2002-10-17
HU228076B1 (en) 2012-10-29
PL196770B1 (pl) 2008-01-31
EP1493751A1 (en) 2005-01-05
EP2272870B1 (en) 2013-05-08
ATE277950T1 (de) 2004-10-15
RU2001101454A (ru) 2003-01-20
JP5478519B2 (ja) 2014-04-23
HK1151044A1 (en) 2012-01-20
BR9911131A (pt) 2001-03-06
AU4257299A (en) 1999-12-30
EP1084147A1 (en) 2001-03-21
ID27417A (id) 2001-04-05
EP2270044A1 (en) 2011-01-05
CN1196714C (zh) 2005-04-13
NZ509135A (en) 2002-10-25
WO1999064462A1 (en) 1999-12-16

Similar Documents

Publication Publication Date Title
HUP0101988A2 (hu) Eljárás intravénás beadásra alkalmas immunglobulinok és más immunglobulin termékek előállítására
US6485932B1 (en) Composition comprising immunoglobulin
JP4644203B2 (ja) 安定性を高めた免疫グロブリン配合物
AU700788B2 (en) Liquid immunoglobulin formulations
US5346992A (en) Process for isolating human albumin from supernatant IV, in particular IV-4, or from COHN's fraction V or from an analogous supernatant or fraction
CN105263947A (zh) 单克隆抗体的纯化工艺
KR920701255A (ko) 에리쓰로포이에틴 동형체(eryihropoietin isoform)
AU698334B2 (en) Method for isolation of highly pure von willebrand factor
FR2632309A1 (fr) Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus
EP0659767B2 (de) Verfahren zur Herstellung eines Konzentrates von Anti-D-Immunoglobulin G und pharmazeutische Zusammensetzung, die dieses enthält
US5371195A (en) Method for purifying factor VIII and preparations obtained
US4874708A (en) Process for the preparation of intra-venously administered gamma-globulins and the gamma-globulins obtained
HU196846B (en) Process for producing biologically active derivatives of human gamma-interferon and pharmaceutical compositions comprising the same
MX9604256A (es) Metodo de recuperacion de inmunoglobulina a partir de fracciones producidas durante el fraccionamiento de plasma sanguineo humano.
Jack et al. Immunoaffinity chromatography of clinical products
US5156967A (en) Process for the purification and pasteurization of urokinase
Gauthier et al. Reactivation of C1-inhibitor polymers by denaturation and gel-filtration chromatography
US5248767A (en) Process for the preparation of a pasteurized immunoglobulin preparation using ethanol
US4723000A (en) Human interferon gamma and interleukin-2
JPH0568583A (ja) 組換えヒトβ−インターフエロンの精製方法
French et al. Isolation and partial characterization of a fragment corresponding to the dimeric form of the CH2 domain of rabbit IgG
GEP19971033B (en) Method of preparing lysozyme dimers

Legal Events

Date Code Title Description
GB9A Succession in title

Owner name: CSL BEHRING AG, CH

Free format text: FORMER OWNER(S): STATENS SERUM INSTITUT, DK