KR20200136464A - 단량체성 모노클로날 항체를 정제하는 방법 - Google Patents
단량체성 모노클로날 항체를 정제하는 방법 Download PDFInfo
- Publication number
- KR20200136464A KR20200136464A KR1020207030734A KR20207030734A KR20200136464A KR 20200136464 A KR20200136464 A KR 20200136464A KR 1020207030734 A KR1020207030734 A KR 1020207030734A KR 20207030734 A KR20207030734 A KR 20207030734A KR 20200136464 A KR20200136464 A KR 20200136464A
- Authority
- KR
- South Korea
- Prior art keywords
- monoclonal antibody
- cell culture
- species
- ser
- protein
- Prior art date
- Legal status (The legal status 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 status listed.)
- Ceased
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- 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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
- B01D15/361—Ion-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 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
- B01D15/3804—Affinity 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
- C07K1/165—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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2500/00—Specific components of cell culture medium
- C12N2500/30—Organic components
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2500/00—Specific components of cell culture medium
- C12N2500/60—Buffer, e.g. pH regulation, osmotic pressure
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862649976P | 2018-03-29 | 2018-03-29 | |
| US62/649,976 | 2018-03-29 | ||
| PCT/US2019/024565 WO2019191416A1 (en) | 2018-03-29 | 2019-03-28 | Methods of purifying monomeric monoclonal antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| KR20200136464A true KR20200136464A (ko) | 2020-12-07 |
Family
ID=66286977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020207030734A Ceased KR20200136464A (ko) | 2018-03-29 | 2019-03-28 | 단량체성 모노클로날 항체를 정제하는 방법 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20210009632A1 (https=) |
| EP (1) | EP3774882A1 (https=) |
| JP (2) | JP2021519752A (https=) |
| KR (1) | KR20200136464A (https=) |
| CN (1) | CN112313248A (https=) |
| WO (1) | WO2019191416A1 (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR102198A1 (es) | 2014-10-09 | 2017-02-08 | Regeneron Pharma | Proceso para reducir partículas subvisibles en una formulación farmacéutica |
| US11020686B2 (en) | 2016-08-16 | 2021-06-01 | Regeneron Pharmaceuticals, Inc. | Methods for quantitating individual antibodies from a mixture |
| JP7102401B2 (ja) | 2016-10-25 | 2022-07-19 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | クロマトグラフィーデータ解析のための方法およびシステム |
| CA3073935A1 (en) | 2017-09-19 | 2019-03-28 | Regeneron Pharmaceuticals, Inc. | Methods of reducing particle formation and compositions formed thereby |
| TWI853823B (zh) | 2018-07-02 | 2024-09-01 | 美商里珍納龍藥品有限公司 | 自混合物製備多肽之系統及方法 |
| EA202192422A1 (ru) | 2019-03-05 | 2021-12-09 | Ридженерон Фармасьютикалз, Инк. | Человеческий сывороточный альбумин в составах |
| JP2022531317A (ja) | 2019-05-03 | 2022-07-06 | ジェネンテック, インコーポレイテッド | 精製プラットフォームから得られた組成物中の酵素加水分解活性速度を低下させる方法 |
| EP4090666A1 (en) | 2020-01-15 | 2022-11-23 | F. Hoffmann-La Roche AG | Methods to decrease impurities from recombinant protein manufacturing processes |
| WO2021191684A1 (en) * | 2020-03-27 | 2021-09-30 | Haemalogix Pty Ltd | Composition and method |
| CA3198684A1 (en) * | 2020-10-30 | 2022-05-05 | Genentech, Inc. | Purification platforms for obtaining pharmaceutical compositions having a reduced hydrolytic enzyme activity rate |
Family Cites Families (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US5225539A (en) | 1986-03-27 | 1993-07-06 | Medical Research Council | Recombinant altered antibodies and methods of making altered antibodies |
| US5476996A (en) | 1988-06-14 | 1995-12-19 | Lidak Pharmaceuticals | Human immune system in non-human animal |
| US5223409A (en) | 1988-09-02 | 1993-06-29 | Protein Engineering Corp. | Directed evolution of novel binding proteins |
| GB8823869D0 (en) | 1988-10-12 | 1988-11-16 | Medical Res Council | Production of antibodies |
| US5530101A (en) | 1988-12-28 | 1996-06-25 | Protein Design Labs, Inc. | Humanized immunoglobulins |
| US6150584A (en) | 1990-01-12 | 2000-11-21 | Abgenix, Inc. | Human antibodies derived from immunized xenomice |
| US6075181A (en) | 1990-01-12 | 2000-06-13 | Abgenix, Inc. | Human antibodies derived from immunized xenomice |
| US6673986B1 (en) | 1990-01-12 | 2004-01-06 | Abgenix, Inc. | Generation of xenogeneic antibodies |
| DE69120146T2 (de) | 1990-01-12 | 1996-12-12 | Cell Genesys Inc | Erzeugung xenogener antikörper |
| US5427908A (en) | 1990-05-01 | 1995-06-27 | Affymax Technologies N.V. | Recombinant library screening methods |
| US6172197B1 (en) | 1991-07-10 | 2001-01-09 | Medical Research Council | Methods for producing members of specific binding pairs |
| GB9015198D0 (en) | 1990-07-10 | 1990-08-29 | Brien Caroline J O | Binding substance |
| US5789650A (en) | 1990-08-29 | 1998-08-04 | Genpharm International, Inc. | Transgenic non-human animals for producing heterologous antibodies |
| ATE158021T1 (de) | 1990-08-29 | 1997-09-15 | Genpharm Int | Produktion und nützung nicht-menschliche transgentiere zur produktion heterologe antikörper |
| US5874299A (en) | 1990-08-29 | 1999-02-23 | Genpharm International, Inc. | Transgenic non-human animals capable of producing heterologous antibodies |
| US5545806A (en) | 1990-08-29 | 1996-08-13 | Genpharm International, Inc. | Ransgenic non-human animals for producing heterologous antibodies |
| US5770429A (en) | 1990-08-29 | 1998-06-23 | Genpharm International, Inc. | Transgenic non-human animals capable of producing heterologous antibodies |
| WO1993012227A1 (en) | 1991-12-17 | 1993-06-24 | Genpharm International, Inc. | Transgenic non-human animals capable of producing heterologous antibodies |
| US5814318A (en) | 1990-08-29 | 1998-09-29 | Genpharm International Inc. | Transgenic non-human animals for producing heterologous antibodies |
| US6255458B1 (en) | 1990-08-29 | 2001-07-03 | Genpharm International | High affinity human antibodies and human antibodies against digoxin |
| US5877397A (en) | 1990-08-29 | 1999-03-02 | Genpharm International Inc. | Transgenic non-human animals capable of producing heterologous antibodies of various isotypes |
| US5633425A (en) | 1990-08-29 | 1997-05-27 | Genpharm International, Inc. | Transgenic non-human animals capable of producing heterologous antibodies |
| US5625126A (en) | 1990-08-29 | 1997-04-29 | Genpharm International, Inc. | Transgenic non-human animals for producing heterologous antibodies |
| US5661016A (en) | 1990-08-29 | 1997-08-26 | Genpharm International Inc. | Transgenic non-human animals capable of producing heterologous antibodies of various isotypes |
| US6300129B1 (en) | 1990-08-29 | 2001-10-09 | Genpharm International | Transgenic non-human animals for producing heterologous antibodies |
| PT1024191E (pt) | 1991-12-02 | 2008-12-22 | Medical Res Council | Produção de auto-anticorpos a partir de reportórios de segmentos de anticorpo e exibidos em fagos |
| DK0752248T3 (da) | 1992-11-13 | 2000-11-13 | Idec Pharma Corp | Terapeutisk anvendelse af kimæriske og radioaktivt mærkede antistoffer mod humant B-lymfocytbegrænset differentieringsantig |
| JPH08509612A (ja) | 1993-04-26 | 1996-10-15 | ジェンファーム インターナショナル インコーポレイテッド | 異種抗体を産生することができるトランスジェニック非ヒト動物 |
| US5534615A (en) | 1994-04-25 | 1996-07-09 | Genentech, Inc. | Cardiac hypertrophy factor and uses therefor |
| EP1212422B1 (en) | 1999-08-24 | 2007-02-21 | Medarex, Inc. | Human ctla-4 antibodies and their uses |
| CA2430013C (en) | 2000-11-30 | 2011-11-22 | Medarex, Inc. | Transgenic transchromosomal rodents for making human antibodies |
| WO2005060457A2 (en) * | 2003-12-04 | 2005-07-07 | Pdl Biopharma, Inc. | Treatment of inflammatory bowel diseases with anti-ip-10 antibodies |
| ES2533266T5 (es) * | 2007-10-30 | 2018-04-18 | Genentech, Inc. | Purificación de anticuerpos mediante cromatografía de intercambio catiónico |
| EP2480561B1 (en) * | 2009-09-23 | 2016-07-13 | E. R. Squibb & Sons, L.L.C. | Cation exchange chromatography |
| EP2519536A4 (en) * | 2009-12-29 | 2013-06-05 | Reddys Lab Ltd Dr | PROTEIN PURIFICATION BY ION EXCHANGE |
| EP3102603A1 (en) * | 2014-02-07 | 2016-12-14 | Novo Nordisk A/S | Antibody process |
| WO2017095875A1 (en) * | 2015-11-30 | 2017-06-08 | Bristol-Myers Squibb Company | Anti human ip-10 antibodies and their uses |
| US10947268B2 (en) * | 2016-08-12 | 2021-03-16 | Bristol-Myers Squibb Company | Methods of purifying proteins |
-
2019
- 2019-03-28 EP EP19719681.9A patent/EP3774882A1/en active Pending
- 2019-03-28 US US17/042,984 patent/US20210009632A1/en not_active Abandoned
- 2019-03-28 KR KR1020207030734A patent/KR20200136464A/ko not_active Ceased
- 2019-03-28 CN CN201980022886.0A patent/CN112313248A/zh active Pending
- 2019-03-28 JP JP2020552186A patent/JP2021519752A/ja active Pending
- 2019-03-28 WO PCT/US2019/024565 patent/WO2019191416A1/en not_active Ceased
-
2024
- 2024-02-28 JP JP2024028517A patent/JP2024059888A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20210009632A1 (en) | 2021-01-14 |
| JP2021519752A (ja) | 2021-08-12 |
| CN112313248A (zh) | 2021-02-02 |
| JP2024059888A (ja) | 2024-05-01 |
| WO2019191416A1 (en) | 2019-10-03 |
| EP3774882A1 (en) | 2021-02-17 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0105 | International application |
Patent event date: 20201026 Patent event code: PA01051R01D Comment text: International Patent Application |
|
| PG1501 | Laying open of application | ||
| A201 | Request for examination | ||
| PA0201 | Request for examination |
Patent event code: PA02012R01D Patent event date: 20220325 Comment text: Request for Examination of Application |
|
| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
Comment text: Notification of reason for refusal Patent event date: 20240326 Patent event code: PE09021S01D |
|
| E601 | Decision to refuse application | ||
| PE0601 | Decision on rejection of patent |
Patent event date: 20250117 Comment text: Decision to Refuse Application Patent event code: PE06012S01D |