MX2015012361A - Metodos de fabricacion para controlar el contenido de lisina c-terminal, galactosa y acido sialico en proteinas recombinantes. - Google Patents
Metodos de fabricacion para controlar el contenido de lisina c-terminal, galactosa y acido sialico en proteinas recombinantes.Info
- Publication number
- MX2015012361A MX2015012361A MX2015012361A MX2015012361A MX2015012361A MX 2015012361 A MX2015012361 A MX 2015012361A MX 2015012361 A MX2015012361 A MX 2015012361A MX 2015012361 A MX2015012361 A MX 2015012361A MX 2015012361 A MX2015012361 A MX 2015012361A
- Authority
- MX
- Mexico
- Prior art keywords
- sialic acid
- acid content
- terminal lysine
- galactose
- control
- Prior art date
Links
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 title abstract 2
- 239000004472 Lysine Substances 0.000 title abstract 2
- SQVRNKJHWKZAKO-UHFFFAOYSA-N beta-N-Acetyl-D-neuraminic acid Chemical group CC(=O)NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO SQVRNKJHWKZAKO-UHFFFAOYSA-N 0.000 title abstract 2
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- SQVRNKJHWKZAKO-OQPLDHBCSA-N sialic acid Chemical group CC(=O)N[C@@H]1[C@@H](O)C[C@@](O)(C(O)=O)OC1[C@H](O)[C@H](O)CO SQVRNKJHWKZAKO-OQPLDHBCSA-N 0.000 title abstract 2
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 title 1
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 title 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical group OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 title 1
- 229930182830 galactose Chemical group 0.000 title 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 abstract 3
- 239000011701 zinc Substances 0.000 abstract 3
- 229910052725 zinc Inorganic materials 0.000 abstract 3
- 239000001963 growth medium Substances 0.000 abstract 2
- 210000004899 c-terminal region Anatomy 0.000 abstract 1
- 210000004027 cell Anatomy 0.000 abstract 1
- 238000012258 culturing Methods 0.000 abstract 1
- 229960000598 infliximab Drugs 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/54—F(ab')2
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Peptides Or Proteins (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Physics & Mathematics (AREA)
- Plant Pathology (AREA)
- Microbiology (AREA)
Abstract
En la presente se proporciona un método para producir un anticuerpo, como un anticuerpo anti-TNFa (por ejemplo, infliximab) que tiene un contenido de lisina en el extremo C terminal de aproximadamente 20% a aproximadamente 70%, y un contendido de ácido siálico de aproximadamente 1% a aproximadamente 20%, que comprende cultivar una célula huésped sensible al zinc transfectada con ADN que codifica el anticuerpo en un medio de cultivo que comprende por lo menos 0.5 µM de zinc; y controlar la concentración de zinc en el medio de cultivo, para producir así el anticuerpo.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361791094P | 2013-03-15 | 2013-03-15 | |
| PCT/US2014/021574 WO2014149935A1 (en) | 2013-03-15 | 2014-03-07 | Manufacturing methods to control c-terminal lysine, galactose and sialic acid content in recombinant proteins |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2015012361A true MX2015012361A (es) | 2016-04-28 |
| MX366910B MX366910B (es) | 2019-07-30 |
Family
ID=51528780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2015012361A MX366910B (es) | 2013-03-15 | 2014-03-07 | Metodos de fabricacion para controlar el contenido de lisina c-terminal, galactosa y acido sialico en proteinas recombinantes. |
Country Status (27)
| Country | Link |
|---|---|
| US (3) | US20140273092A1 (es) |
| EP (1) | EP2970980B2 (es) |
| JP (1) | JP2016512029A (es) |
| KR (1) | KR102216003B1 (es) |
| CN (1) | CN105378086B (es) |
| AR (2) | AR095660A1 (es) |
| AU (2) | AU2014237635B2 (es) |
| BR (1) | BR112015022971B1 (es) |
| CA (1) | CA2907140A1 (es) |
| CY (1) | CY1120980T1 (es) |
| DK (1) | DK2970980T3 (es) |
| EA (1) | EA201591807A1 (es) |
| ES (1) | ES2690047T3 (es) |
| HR (1) | HRP20181741T1 (es) |
| IL (1) | IL240689B (es) |
| LT (1) | LT2970980T (es) |
| MX (1) | MX366910B (es) |
| PH (1) | PH12015501837B1 (es) |
| PL (1) | PL2970980T3 (es) |
| PT (1) | PT2970980T (es) |
| RS (1) | RS57791B1 (es) |
| SG (1) | SG11201507577RA (es) |
| SI (1) | SI2970980T1 (es) |
| SM (1) | SMT201800550T1 (es) |
| TW (1) | TWI630216B (es) |
| WO (1) | WO2014149935A1 (es) |
| ZA (1) | ZA201507671B (es) |
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| EP2702077A2 (en) | 2011-04-27 | 2014-03-05 | AbbVie Inc. | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| US9150645B2 (en) | 2012-04-20 | 2015-10-06 | Abbvie, Inc. | Cell culture methods to reduce acidic species |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| US9181572B2 (en) | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| WO2014143205A1 (en) | 2013-03-12 | 2014-09-18 | Abbvie Inc. | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US9499614B2 (en) | 2013-03-14 | 2016-11-22 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| WO2014149935A1 (en) * | 2013-03-15 | 2014-09-25 | Janssen Biotech, Inc. | Manufacturing methods to control c-terminal lysine, galactose and sialic acid content in recombinant proteins |
| KR102118240B1 (ko) | 2013-08-20 | 2020-06-03 | 레크 파마슈티칼스 디.디. | 폴리펩티드의 α-아미드화 및/또는 C-말단 아미노산 분열의 제어를 위한 세포 배양 매질 및 방법 |
| WO2015051293A2 (en) | 2013-10-04 | 2015-04-09 | Abbvie, Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
| EA201891093A1 (ru) | 2015-11-03 | 2018-10-31 | Янссен Байотек, Инк. | Антитела, специфически связывающие pd-1, и их применение |
| JP2018536404A (ja) * | 2015-11-09 | 2018-12-13 | ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ | Ｃｈｏ細胞において産生したポリペプチドの品質特性を操作する方法 |
| JP2019502698A (ja) | 2015-12-17 | 2019-01-31 | ヤンセン バイオテツク，インコーポレーテツド | Ｈｌａ−ｄｒに特異的に結合する抗体及びその使用 |
| US11719704B2 (en) | 2015-12-30 | 2023-08-08 | Momenta Pharmaceuticals, Inc. | Methods related to biologics |
| KR102554331B1 (ko) | 2016-08-12 | 2023-07-10 | 얀센 바이오테크 인코포레이티드 | 향상된 효능적 활성을 갖는 Fc 조작된 항-TNFR 수퍼패밀리 구성원 항체 및 그의 사용 방법 |
| CN109863170B (zh) | 2016-08-12 | 2024-08-16 | 詹森生物科技公司 | 具有增强的激动作用和效应子功能的工程化抗体及其他含Fc结构域分子 |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| AU2018281045A1 (en) | 2017-06-05 | 2019-12-12 | Janssen Biotech, Inc. | Engineered multispecific antibodies and other multimeric proteins with asymmetrical CH2-CH3 region mutations |
| KR102692379B1 (ko) | 2017-06-05 | 2024-08-05 | 얀센 바이오테크 인코포레이티드 | Pd-1과 특이적으로 결합하는 항체 및 사용 방법 |
| WO2019077628A1 (en) * | 2017-10-16 | 2019-04-25 | Council Of Scientific & Industrial Research | ZINC SUPPLEMENTATION TO DECREASE GALACTOSYLATION OF RECOMBINANT GLYCOPROTEINS |
| CA3101304A1 (en) | 2018-05-24 | 2019-11-28 | Janssen Biotech, Inc. | Monospecific and multispecific anti-tmeff2 antibodies and their uses |
| CN113474366B (zh) * | 2018-12-31 | 2025-01-17 | 动量制药公司 | 产生优特克单抗的方法 |
| JP2022541332A (ja) | 2019-07-26 | 2022-09-22 | ヤンセン バイオテツク，インコーポレーテツド | カリクレイン関連ペプチダーゼ２抗原結合ドメインを含むタンパク質及びその使用 |
| CR20220054A (es) | 2019-08-15 | 2022-06-06 | Janssen Biotech Inc | Materiales y métodos para fragmentos variables de cadena única mejorado |
| BR112022018176A2 (pt) | 2020-03-13 | 2022-12-06 | Janssen Biotech Inc | Materiais e métodos para ligação de siglec-3/cd33 |
| CA3184189A1 (en) | 2020-05-27 | 2021-12-02 | Janssen Biotech, Inc. | Proteins comprising cd3 antigen binding domains and uses thereof |
| AR123083A1 (es) | 2020-07-29 | 2022-10-26 | Janssen Biotech Inc | Proteínas que comprenden dominios de unión al antígeno hla-g y sus usos |
| TW202231292A (zh) | 2020-10-13 | 2022-08-16 | 美商健生生物科技公司 | 用於調節分化簇ｉｖ及／或ｖｉｉｉ的經生物工程改造之ｔ細胞介導之免疫力、材料、及其他方法 |
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| EP4405392A1 (en) | 2021-09-24 | 2024-07-31 | Janssen Biotech, Inc. | Proteins comprising cd20 binding domains, and uses thereof |
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| WO2024089551A1 (en) | 2022-10-25 | 2024-05-02 | Janssen Biotech, Inc. | Msln and cd3 binding agents and methods of use thereof |
| US20250136688A1 (en) | 2023-08-07 | 2025-05-01 | Janssen Biotech, Inc. | Stabilized cd3 antigen binding agents and methods of use thereof |
| WO2025032508A1 (en) | 2023-08-07 | 2025-02-13 | Janssen Biotech, Inc. | Enpp3 and cd3 binding agents and methods of use thereof |
| WO2025137410A1 (en) * | 2023-12-20 | 2025-06-26 | Apogee Therapeutics, Inc. | Pharmaceutical compositions of anti-il-13 antibodies with and without c-terminal lysine |
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| US4376110A (en) | 1980-08-04 | 1983-03-08 | Hybritech, Incorporated | Immunometric assays using monoclonal antibodies |
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| CA2450289A1 (en) † | 2003-03-20 | 2005-05-19 | Imclone Systems Incorporated | Method of producing an antibody to epidermal growth factor receptor |
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| WO2012147053A1 (en) * | 2011-04-29 | 2012-11-01 | Biocon Research Limited | A method for reducing heterogeneity of antibodies and a process of producing the antibodies thereof |
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| US9181572B2 (en) * | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| WO2014149935A1 (en) * | 2013-03-15 | 2014-09-25 | Janssen Biotech, Inc. | Manufacturing methods to control c-terminal lysine, galactose and sialic acid content in recombinant proteins |
-
2014
- 2014-03-07 WO PCT/US2014/021574 patent/WO2014149935A1/en active Application Filing
- 2014-03-07 CN CN201480015815.5A patent/CN105378086B/zh not_active Expired - Fee Related
- 2014-03-07 KR KR1020157029490A patent/KR102216003B1/ko not_active Expired - Fee Related
- 2014-03-07 PL PL14768761T patent/PL2970980T3/pl unknown
- 2014-03-07 ES ES14768761.0T patent/ES2690047T3/es active Active
- 2014-03-07 LT LTEP14768761.0T patent/LT2970980T/lt unknown
- 2014-03-07 SI SI201430848T patent/SI2970980T1/sl unknown
- 2014-03-07 JP JP2016500790A patent/JP2016512029A/ja active Pending
- 2014-03-07 HR HRP20181741TT patent/HRP20181741T1/hr unknown
- 2014-03-07 RS RS20181228A patent/RS57791B1/sr unknown
- 2014-03-07 DK DK14768761.0T patent/DK2970980T3/en active
- 2014-03-07 PT PT14768761T patent/PT2970980T/pt unknown
- 2014-03-07 MX MX2015012361A patent/MX366910B/es active IP Right Grant
- 2014-03-07 EP EP14768761.0A patent/EP2970980B2/en active Active
- 2014-03-07 CA CA2907140A patent/CA2907140A1/en active Pending
- 2014-03-07 SM SM20180550T patent/SMT201800550T1/it unknown
- 2014-03-07 AU AU2014237635A patent/AU2014237635B2/en not_active Ceased
- 2014-03-07 SG SG11201507577RA patent/SG11201507577RA/en unknown
- 2014-03-07 EA EA201591807A patent/EA201591807A1/ru unknown
- 2014-03-07 BR BR112015022971-9A patent/BR112015022971B1/pt not_active IP Right Cessation
- 2014-03-13 TW TW103108900A patent/TWI630216B/zh not_active IP Right Cessation
- 2014-03-13 AR ARP140100976A patent/AR095660A1/es not_active Application Discontinuation
- 2014-03-13 US US14/207,915 patent/US20140273092A1/en not_active Abandoned
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2015
- 2015-08-20 PH PH12015501837A patent/PH12015501837B1/en unknown
- 2015-08-20 IL IL240689A patent/IL240689B/en unknown
- 2015-10-14 ZA ZA2015/07671A patent/ZA201507671B/en unknown
- 2015-12-23 US US14/757,691 patent/US11149085B2/en active Active
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2018
- 2018-11-02 CY CY181101150T patent/CY1120980T1/el unknown
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2020
- 2020-06-11 AU AU2020203864A patent/AU2020203864B2/en not_active Ceased
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2021
- 2021-09-29 US US17/489,744 patent/US20220089712A1/en not_active Abandoned
-
2022
- 2022-02-14 AR ARP220100291A patent/AR124871A2/es unknown
Also Published As
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