DK2640743T3 - Fremgangsmåder til fremstilling af rekombinante proteiner - Google Patents
Fremgangsmåder til fremstilling af rekombinante proteiner Download PDFInfo
- Publication number
- DK2640743T3 DK2640743T3 DK11801886.0T DK11801886T DK2640743T3 DK 2640743 T3 DK2640743 T3 DK 2640743T3 DK 11801886 T DK11801886 T DK 11801886T DK 2640743 T3 DK2640743 T3 DK 2640743T3
- Authority
- DK
- Denmark
- Prior art keywords
- cell
- polyclonal
- cells
- cell population
- vector
- Prior art date
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
- C07K16/1267—Gram-positive bacteria
- C07K16/1271—Micrococcaceae (F); Staphylococcaceae (F), e.g. Staphylococcus (G)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
-
- 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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
- C12N15/1034—Isolating an individual clone by screening libraries
- C12N15/1093—General methods of preparing gene libraries, not provided for in other subgroups
-
- 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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/67—General methods for enhancing the expression
-
- 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
- C12N2799/00—Uses of viruses
- C12N2799/02—Uses of viruses as vector
- C12N2799/021—Uses of viruses as vector for the expression of a heterologous nucleic acid
- C12N2799/025—Uses of viruses as vector for the expression of a heterologous nucleic acid where the vector is derived from a parvovirus
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Plant Pathology (AREA)
- Physics & Mathematics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Crystallography & Structural Chemistry (AREA)
- Bioinformatics & Computational Biology (AREA)
- Neurology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Pain & Pain Management (AREA)
- Neurosurgery (AREA)
- Rheumatology (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (15)
1. Fremgangsmåde til fremstilling af en polyklonal cellepopulation, hvilken fremgangsmåde omfatter trinene: a) transformering af en population af værtsceller med mindst én vektor, der omfatter mindst én kopi af en nukleinsyresekvens, der koder for en bestanddel af en polyklonal proteinsammensætning, i nærvær af adenoassocieret viral (AAV) rep eller retroviral integrase, således at præference-integration af nukleinsyresekvensen i genomet i hver af værtscellerne finder sted i et antal placeringer, der genkendes af den adenoassocierede virale (AAV) rep eller integrase, hvor præference-integration betyder, at der er variabilitet i stedet eller stederne, hvor nukleinsyresekvensen integreres, således at integration hverken er vilkårlig eller enkeltstedsspecifik, og hvor værtsceller efter præference-integrationen ikke er genetisk identiske på grund af variabilitet i antallet og/eller placeringen af integrationsted/steder; b) efterfølgende generering fra værtscellerne af en første cellepopulation uden klonal selektion eller produktion af individuelle cellelinjer, der er i stand til at danne bestanddelen af den polyklonale proteinsammensætning; og c) gentagelse af trin (a) og (b) mindst én gang til generering af mindst en anden cellepopulation, hvor den anden cellepopulation er i stand til at danne en anden bestanddel af den polyklonale proteinsammensætning; og d) blanding af mindst den første cellepopulation og den anden cellepopulation, hvor hver cellepopulation omfatter mere end 10.000 individuelle celler, til frembringelse af en polyklonal cellepopulation, der er i stand til at danne den polyklonale proteinsammensætning.
2. Fremgangsmåde ifølge krav 1, hvor cellepopulationen genereret i trin (b) omfatter transformerede værtsceller og ikke-transformerede værtsceller.
3. Fremgangsmåde ifølge krav 1 eller 2, der yderligere efter trin (b) omfatter selektion af cellepopulationen af transformerede værtsceller.
4. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor vektoren er en adenoassocieret viral (AAV) vektor eller en retroviral vektor.
5. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor den polyklonale proteinsammensætning omfatter et polypeptid, der omfatter en variabel region af tung kæde af immunoglobulin, og et polypeptid, der omfatter en variabel region af let kæde af immunoglobulin, der sammen binder en specifik antigen epitop.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1-4, hvor den polyklonale proteinsammensætning omfatter to polypeptider, der sammen danner en T-cellereceptor (TCR).
7. Fremgangsmåde ifølge krav 6, hvor de to polypeptider, der sammen danner en TCR, omfatter: (a) et polypeptid, der omfatter en alfa-kæde af en TCR, og et polypeptid, der omfatter en beta-kæde of en TCR; eller (b) et polypeptid, der omfatter en gamma-kæde af en TCR, og et polypeptid, der omfatter en delta-kæde af en TCR.
8. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor bestanddelen af den polyklonale proteinsammensætning, der kodes af nukleinsyresekvensen, er et smitstof af et patogen eller en isoform deraf.
9. Fremgangsmåde ifølge krav 1, der yderligere omfatter trinet oprensning af den polyklonale proteinsammensætning fra den polyklonale cellepopulation dannet i trin (d) .
10. Fremgangsmåde ifølge krav 1, hvor den polyklonale cellepopulation dannet i trin (d) omfatter mindst 100.000 celler, mindst 1.000.000 celler eller mindst 10.000.000 celler.
11. Fremgangsmåde ifølge krav 1, hvor i trin (a) værtscellerne transformeres med et bibliotek af vektorer, der koder for et multimert protein, eventuelt hvor det multimere protein omfatter et polypeptid, der omfatter en variabel region af tung kæde af immunoglobulin, og et polypeptid, der omfatter en variabel region af let kæde af immunoglobulin, der sammen binder en specifik antigen epitop.
12. Fremgangsmåde ifølge krav 1, hvor i trin (a) værtscellerne transformeres med den mindst ene vektor mindst to gange eller mindst fem gange.
13. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor den polyklonale cellepopulation omfatter mindst 3, 5, 10, 15, 20, 25 eller 50 cellepopulationer, der hver er i stand til at danne forskellige proteiner.
14. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor cellepopulationen genereret ved udførelse af trin (a) og (b) er i stand til at danne mindst 2, 5 eller 10 forskellige bestanddele af den polyklonale proteinsammensætning.
15. Fremgangsmåde ifølge krav 13, hvor AAV-rep-proteinet tilvejebringes for værtscellen på en anden DNA-vektor eller som et rekombinant protein.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US41422510P | 2010-11-16 | 2010-11-16 | |
| PCT/US2011/061092 WO2012068317A2 (en) | 2010-11-16 | 2011-11-16 | Methods for producing recombinant proteins |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2640743T3 true DK2640743T3 (da) | 2017-01-23 |
Family
ID=45406837
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11801886.0T DK2640743T3 (da) | 2010-11-16 | 2011-11-16 | Fremgangsmåder til fremstilling af rekombinante proteiner |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US8617881B2 (da) |
| EP (1) | EP2640743B1 (da) |
| JP (1) | JP6092782B2 (da) |
| AU (1) | AU2011329872B2 (da) |
| CA (1) | CA2817751C (da) |
| DK (1) | DK2640743T3 (da) |
| WO (1) | WO2012068317A2 (da) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI698240B (zh) | 2012-05-15 | 2020-07-11 | 澳大利亞商艾佛蘭屈澳洲私營有限公司 | 使用腺相關病毒(aav)sflt-1治療老年性黃斑部退化(amd) |
| ES2822551T3 (es) | 2014-03-17 | 2021-05-04 | Adverum Biotechnologies Inc | Composiciones y métodos para la expresión génica mejorada en células de los conos |
| US11566082B2 (en) | 2014-11-17 | 2023-01-31 | Cytiva Bioprocess R&D Ab | Mutated immunoglobulin-binding polypeptides |
| FI3265178T3 (fi) | 2015-03-02 | 2026-08-03 | Adverum Biotechnologies Inc | Koostumuksia ja menetelmiä polynukleotidien viemiseksi intravitreaalisesti retinaalisiin tappisoluihin |
| TWI554608B (zh) * | 2015-03-27 | 2016-10-21 | Univ China Medical | A nucleic acid sequence segment for enhancing protein expression, an expression vector comprising a sequence segment thereof, and a kit comprising its expression vector |
| GB2545763A (en) * | 2015-12-23 | 2017-06-28 | Adverum Biotechnologies Inc | Mutant viral capsid libraries and related systems and methods |
| JP7122974B2 (ja) | 2016-05-11 | 2022-08-22 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 変異免疫グロブリン結合ポリペプチド |
| US10654887B2 (en) | 2016-05-11 | 2020-05-19 | Ge Healthcare Bio-Process R&D Ab | Separation matrix |
| JP7031934B2 (ja) | 2016-05-11 | 2022-03-08 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 分離マトリックス |
| US10703774B2 (en) | 2016-09-30 | 2020-07-07 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| WO2017194592A1 (en) | 2016-05-11 | 2017-11-16 | Ge Healthcare Bioprocess R&D Ab | Method of storing a separation matrix |
| EP3455241B1 (en) | 2016-05-11 | 2022-02-23 | Cytiva BioProcess R&D AB | Method of cleaning and/or sanitizing a separation matrix |
| US10730908B2 (en) | 2016-05-11 | 2020-08-04 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| US12448411B2 (en) | 2016-09-30 | 2025-10-21 | Cytiva Bioprocess R&D Ab | Separation method |
| US12247065B2 (en) | 2018-06-22 | 2025-03-11 | Genmab A/S | Method for producing a controlled mixture of two or more different antibodies |
| KR102559149B1 (ko) | 2018-10-26 | 2023-07-24 | 에프. 호프만-라 로슈 아게 | 재조합효소 매개 카세트 교환을 이용한 다중특이적 항체 스크리닝 방법 |
| WO2022259190A1 (en) * | 2021-06-10 | 2022-12-15 | Janssen Biotech, Inc. | Nucleic acid coding for klk2-gpi fusion protein, recombinant cells, and uses thereof |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1293460C (en) | 1985-10-07 | 1991-12-24 | Brian Lee Sauer | Site-specific recombination of dna in yeast |
| US4937190A (en) | 1987-10-15 | 1990-06-26 | Wisconsin Alumni Research Foundation | Translation enhancer |
| US5780225A (en) | 1990-01-12 | 1998-07-14 | Stratagene | Method for generating libaries of antibody genes comprising amplification of diverse antibody DNAs and methods for using these libraries for the production of diverse antigen combining molecules |
| WO1992015694A1 (en) | 1991-03-08 | 1992-09-17 | The Salk Institute For Biological Studies | Flp-mediated gene modification in mammalian cells, and compositions and cells useful therefor |
| DE4228458A1 (de) | 1992-08-27 | 1994-06-01 | Beiersdorf Ag | Multicistronische Expressionseinheiten und deren Verwendung |
| US5686120A (en) | 1995-05-22 | 1997-11-11 | Wisconsin Alumni Research Foundation | Pre-mRNA processing enhancer and method for intron-independent gene expression |
| RO120148B1 (ro) | 1997-03-14 | 2005-09-30 | Idec Pharmaceuticals Corporation | Sistem vector şi procedeu de inserţie a unui fragment adn, în genomul celulelor de mamifere |
| US6136597A (en) | 1997-09-18 | 2000-10-24 | The Salk Institute For Biological Studies | RNA export element |
| DE60044142D1 (de) | 1999-07-23 | 2010-05-20 | Univ California | Dna-rekombination in eukaryotischen zellen mittels des rekombinationszentrums vom bakteriophag phic31 |
| US6852510B2 (en) | 2000-07-03 | 2005-02-08 | Gala Design Inc | Host cells containing multiple integrating vectors |
| AU2001270252B2 (en) | 2000-07-03 | 2007-02-08 | Catalent Pharma Solutions, Llc | Expression vectors |
| US20030157641A1 (en) | 2001-11-16 | 2003-08-21 | Idec Pharmaceuticals Corporation | Polycistronic expression of antibodies |
| EA013225B1 (ru) * | 2003-01-07 | 2010-04-30 | Симфоген А/С | Способ получения линии клеток, продуцирующей рекомбинантный поликлональный белок, способ получения поликлонального белка, линия клеток, продуцирующая рекомбинантный поликлональный белок, библиотека векторов, популяция клеток |
| TWI333977B (en) | 2003-09-18 | 2010-12-01 | Symphogen As | Method for linking sequences of interest |
| WO2007148971A2 (en) * | 2006-06-21 | 2007-12-27 | Amsterdam Molecular Therapeutics B.V. | Vectors with modified initiation codon for the translation of aav-rep78 useful for production of aav in insect cells |
| BRPI0812091A2 (pt) * | 2007-05-25 | 2014-10-14 | Symphogen As | Método para fabricar uma proteína policlonal recombinante |
| RU2010147652A (ru) * | 2008-04-23 | 2012-05-27 | Симфоген А/С (Dk) | Способы производства поликлонального белка |
-
2011
- 2011-11-16 JP JP2013539992A patent/JP6092782B2/ja not_active Expired - Fee Related
- 2011-11-16 EP EP11801886.0A patent/EP2640743B1/en active Active
- 2011-11-16 DK DK11801886.0T patent/DK2640743T3/da active
- 2011-11-16 CA CA2817751A patent/CA2817751C/en active Active
- 2011-11-16 AU AU2011329872A patent/AU2011329872B2/en active Active
- 2011-11-16 WO PCT/US2011/061092 patent/WO2012068317A2/en not_active Ceased
-
2012
- 2012-06-13 US US13/495,993 patent/US8617881B2/en active Active
-
2013
- 2013-09-26 US US14/037,833 patent/US9447174B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CA2817751C (en) | 2019-04-30 |
| US8617881B2 (en) | 2013-12-31 |
| EP2640743B1 (en) | 2016-10-05 |
| EP2640743A2 (en) | 2013-09-25 |
| CA2817751A1 (en) | 2012-05-24 |
| WO2012068317A2 (en) | 2012-05-24 |
| US9447174B2 (en) | 2016-09-20 |
| JP6092782B2 (ja) | 2017-03-08 |
| US20120302464A1 (en) | 2012-11-29 |
| JP2014501505A (ja) | 2014-01-23 |
| AU2011329872B2 (en) | 2017-04-13 |
| US20140127743A1 (en) | 2014-05-08 |
| WO2012068317A3 (en) | 2012-08-16 |
| AU2011329872A1 (en) | 2013-06-06 |
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