BR112017026228A2 - método para preparação de imunoglobulina da hepatite b derivada do plasma - Google Patents
método para preparação de imunoglobulina da hepatite b derivada do plasmaInfo
- Publication number
- BR112017026228A2 BR112017026228A2 BR112017026228-2A BR112017026228A BR112017026228A2 BR 112017026228 A2 BR112017026228 A2 BR 112017026228A2 BR 112017026228 A BR112017026228 A BR 112017026228A BR 112017026228 A2 BR112017026228 A2 BR 112017026228A2
- Authority
- BR
- Brazil
- Prior art keywords
- immunoglobulin
- hepatitis
- plasma
- preparing
- derived
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 6
- 229940036107 hepatitis b immunoglobulin Drugs 0.000 title abstract 4
- 108060003951 Immunoglobulin Proteins 0.000 abstract 2
- 208000007536 Thrombosis Diseases 0.000 abstract 2
- 208000006454 hepatitis Diseases 0.000 abstract 2
- 231100000283 hepatitis Toxicity 0.000 abstract 2
- 102000018358 immunoglobulin Human genes 0.000 abstract 2
- 239000012535 impurity Substances 0.000 abstract 2
- 239000000463 material Substances 0.000 abstract 2
- 238000002360 preparation method Methods 0.000 abstract 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 abstract 1
- 102000004506 Blood Proteins Human genes 0.000 abstract 1
- 108010017384 Blood Proteins Proteins 0.000 abstract 1
- 239000003957 anion exchange resin Substances 0.000 abstract 1
- 239000003729 cation exchange resin Substances 0.000 abstract 1
- 238000000502 dialysis Methods 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/29—Hepatitis virus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
- A61K39/39525—Purification
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- 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
-
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
- C07K16/1002—Coronaviridae
- C07K16/1003—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Virology (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Water Supply & Treatment (AREA)
- Pulmonology (AREA)
- Communicable Diseases (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
Abstract
método para preparação de imunoglobulina da hepatite b derivada do plasma a presente invenção refere-se a um método de preparação de uma preparação de imunoglobulina da hepatite b humana derivada do plasma. mais especificamente, refere-se a um método de preparação de uma preparação de imunoglobulina da hepatite b derivada de plasma humano, caracterizada pela fração ii da proteína plasmática (fração ii) contendo imunoglobulina humana contra a hepatite b ser concentrada por diálise e, em seguida, materiais que produzem trombo e impurezas formadas durante os processos serem removidos por técnicas de purificação de resina de troca aniônica e resina de troca catiônica. pela utilização do método proposto, a eficiência de remoção de impurezas e materiais que produzem trombo é aumentada e um conteúdo de polímero é mantido, através do qual é possível produzir imunoglobulina humana contra a hepatite b com a estabilidade e a melhoria da qualidade.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2015-0080042 | 2015-06-05 | ||
| KR1020150080042A KR101657690B1 (ko) | 2015-06-05 | 2015-06-05 | 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법 |
| PCT/KR2016/005837 WO2016195387A1 (ko) | 2015-06-05 | 2016-06-02 | 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112017026228A2 true BR112017026228A2 (pt) | 2018-09-11 |
Family
ID=57102805
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112017026228-2A BR112017026228A2 (pt) | 2015-06-05 | 2016-06-02 | método para preparação de imunoglobulina da hepatite b derivada do plasma |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US10406223B2 (pt) |
| EP (1) | EP3305800B1 (pt) |
| JP (1) | JP6514412B2 (pt) |
| KR (1) | KR101657690B1 (pt) |
| CN (1) | CN107849086B (pt) |
| BR (1) | BR112017026228A2 (pt) |
| WO (1) | WO2016195387A1 (pt) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101917196B1 (ko) * | 2014-03-11 | 2018-11-09 | 주식회사 녹십자홀딩스 | 면역글로불린의 정제방법 |
| ES2769783T3 (es) * | 2014-03-11 | 2020-06-29 | Green Cross Holdings Corp | Procedimiento de purificación de inmunoglobulina |
| KR101941974B1 (ko) * | 2016-11-18 | 2019-01-24 | 주식회사 녹십자 | 혈장 단백질 정제시 fxi의 제거방법 |
| KR20190047376A (ko) | 2017-10-27 | 2019-05-08 | 주식회사 녹십자 | 개선된 면역글로불린의 정제방법 |
| 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 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2604759C2 (de) | 1976-02-07 | 1983-06-01 | SCHURA Blutderivate GmbH & Co KG, 4150 Krefeld | Verfahren zur Gewinnung von iv-verträglichen Γglobulinen |
| US4124576A (en) | 1976-12-03 | 1978-11-07 | Coval M L | Method of producing intravenously injectable gamma globulin |
| JPS617561A (ja) | 1984-06-20 | 1986-01-14 | Toshiba Corp | 表示素子用放電灯 |
| DE3624258A1 (de) | 1986-07-18 | 1988-01-21 | Basf Ag | Verfahren zur herstellung von chlorcarbonsaeurechloriden |
| DE59009020D1 (de) * | 1990-03-22 | 1995-06-08 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verträglichen Immunglobulin-G-Präparates. |
| JP4685238B2 (ja) * | 1998-06-09 | 2011-05-18 | ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト | 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法 |
| PL196770B1 (pl) * | 1998-06-09 | 2008-01-31 | Statens Seruminstitut | Sposób oczyszczania immunoglobuliny, produkt immunoglobuliny i jego zastosowanie |
| KR20150008503A (ko) * | 2007-10-30 | 2015-01-22 | 제넨테크, 인크. | 양이온 교환 크로마토그래피에 의한 항체 정제 |
| 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 |
| CN104001172B (zh) * | 2014-06-12 | 2016-02-24 | 新疆德源生物工程有限公司 | 一种静脉注射用乙型肝炎人免疫球蛋白的制备工艺 |
| CN104231075B (zh) * | 2014-09-02 | 2017-03-22 | 江西博雅生物制药股份有限公司 | 一种乙型肝炎人免疫球蛋白的制备工艺 |
-
2015
- 2015-06-05 KR KR1020150080042A patent/KR101657690B1/ko active IP Right Grant
-
2016
- 2016-06-02 US US15/579,427 patent/US10406223B2/en active Active
- 2016-06-02 JP JP2018515746A patent/JP6514412B2/ja active Active
- 2016-06-02 WO PCT/KR2016/005837 patent/WO2016195387A1/ko active Application Filing
- 2016-06-02 BR BR112017026228-2A patent/BR112017026228A2/pt active Search and Examination
- 2016-06-02 CN CN201680039211.3A patent/CN107849086B/zh active Active
- 2016-06-02 EP EP16803742.2A patent/EP3305800B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| EP3305800B1 (en) | 2024-02-28 |
| US20180140699A1 (en) | 2018-05-24 |
| EP3305800C0 (en) | 2024-02-28 |
| EP3305800A4 (en) | 2018-12-19 |
| KR101657690B1 (ko) | 2016-09-19 |
| WO2016195387A1 (ko) | 2016-12-08 |
| JP2018528249A (ja) | 2018-09-27 |
| US10406223B2 (en) | 2019-09-10 |
| EP3305800A1 (en) | 2018-04-11 |
| JP6514412B2 (ja) | 2019-05-15 |
| CN107849086A (zh) | 2018-03-27 |
| CN107849086B (zh) | 2022-02-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] |