PE20231507A1 - Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped - Google Patents
Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huespedInfo
- Publication number
- PE20231507A1 PE20231507A1 PE2023001345A PE2023001345A PE20231507A1 PE 20231507 A1 PE20231507 A1 PE 20231507A1 PE 2023001345 A PE2023001345 A PE 2023001345A PE 2023001345 A PE2023001345 A PE 2023001345A PE 20231507 A1 PE20231507 A1 PE 20231507A1
- Authority
- PE
- Peru
- Prior art keywords
- host cell
- antibody
- protein
- seq
- n3pglu
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000011091 antibody purification Methods 0.000 title 1
- 210000004027 cell Anatomy 0.000 abstract 5
- 102000004169 proteins and genes Human genes 0.000 abstract 4
- 108090000623 proteins and genes Proteins 0.000 abstract 4
- 102000001708 Protein Isoforms Human genes 0.000 abstract 2
- 108010029485 Protein Isoforms Proteins 0.000 abstract 2
- 125000003275 alpha amino acid group Chemical group 0.000 abstract 2
- ZIIUUSVHCHPIQD-UHFFFAOYSA-N 2,4,6-trimethyl-N-[3-(trifluoromethyl)phenyl]benzenesulfonamide Chemical compound CC1=CC(C)=CC(C)=C1S(=O)(=O)NC1=CC=CC(C(F)(F)F)=C1 ZIIUUSVHCHPIQD-UHFFFAOYSA-N 0.000 abstract 1
- 102000007469 Actins Human genes 0.000 abstract 1
- 108010085238 Actins Proteins 0.000 abstract 1
- 102000005572 Cathepsin A Human genes 0.000 abstract 1
- 108010059081 Cathepsin A Proteins 0.000 abstract 1
- 108010026751 High-Temperature Requirement A Serine Peptidase 1 Proteins 0.000 abstract 1
- 102000018978 High-Temperature Requirement A Serine Peptidase 1 Human genes 0.000 abstract 1
- 102100027612 Kallikrein-11 Human genes 0.000 abstract 1
- 101710115807 Kallikrein-11 Proteins 0.000 abstract 1
- 102000015439 Phospholipases Human genes 0.000 abstract 1
- 108010064785 Phospholipases Proteins 0.000 abstract 1
- 102000005881 S100 Calcium Binding Protein A6 Human genes 0.000 abstract 1
- 108010005260 S100 Calcium Binding Protein A6 Proteins 0.000 abstract 1
- 102100023341 Ubiquitin-40S ribosomal protein S27a Human genes 0.000 abstract 1
- 230000000295 complement effect Effects 0.000 abstract 1
- 238000004895 liquid chromatography mass spectrometry Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 108010011179 ribosomal protein S27a Proteins 0.000 abstract 1
Classifications
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- 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
- 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
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- 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
-
- 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]
-
- 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
-
- 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
-
- 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
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Virology (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Pulmonology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
Referida a una composicion farmaceutica que comprende un anticuerpo que se une a N3pGlu A? humano (anticuerpo anti-N3pGlu A?), en donde el anticuerpo anti-N3pGlu A? se preparo mediante un proceso que comprende purificar el anticuerpo anti-N3pGlu a partir de una celula huesped de mamifero, y en donde el contenido total de proteinas de la celula huesped (HCP) en la composicion es menos de aproximadamente 100 ppm (medido por LCMS) y la composicion comprende una de, combinaciones de, o todas las siguientes proteinas de la celula huesped: proteina S100-A6, proteina S100-A11, proteina 2 similar a la fosfolipasa B, proteina protectora lisosomal, proteina ribosomal S27a de 40S-ubiquitina, calicreina-11, isoforma X1 de la serina proteasa HTRA1, subcomponente C1r del complemento, actina, isoforma X1 del musculo liso aortico, proteina cognada de choque termico de 71 kDa y peroxirredoxina-1. El anticuerpo antiN3pGlu A? comprende una cadena pesada (HC) y una cadena ligera (LC), en donde la cadena ligera comprende una region variable de la cadena ligera (LCVR) y la cadena pesada comprende una region variable de la cadena pesada (HCVR), en donde la LCVR comprende las secuencias de aminoacidos LCDR1, LCDR2 y LCDR3, y la HCVR comprende las secuencias de aminoacidos HCDR1, HCDR2 y HCDR3, en donde LCDR1 es KSSQSLLYSRGKTYLN (SEQ ID NO:17), LCDR2 es AVSKLDS (SEQ ID NO:18), LCDR3 es VQGTHYPFT (SEQ ID NO:19), HCDR1 es GYDFTRYYIN (SEQ ID NO:20), HCDR2 es WINPGSGNTKYNEKFKG (SEQ ID NO:21) y HCDR3 es EGITVY (SEQ ID NO:22). Tambien esta referida a metodos para reducir el contenido de proteinas de la celula huesped en una preparacion de anticuerpo producido de forma recombinante en una celula huesped en el proceso de fabricacion de anticuerpos.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063086915P | 2020-10-02 | 2020-10-02 | |
| PCT/US2021/053407 WO2022072934A1 (en) | 2020-10-02 | 2021-10-04 | Methods for reducing host cell protein content in antibody purification processes and antibody compositions having reduced host cell protein content |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20231507A1 true PE20231507A1 (es) | 2023-09-26 |
Family
ID=78621988
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2023001345A PE20231507A1 (es) | 2020-10-02 | 2021-10-04 | Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US20230406914A1 (es) |
| EP (2) | EP4222160A1 (es) |
| JP (3) | JP7668351B2 (es) |
| KR (2) | KR20230061462A (es) |
| CN (2) | CN116547292A (es) |
| AR (1) | AR123688A1 (es) |
| AU (2) | AU2021355518A1 (es) |
| BR (1) | BR112023004871A2 (es) |
| CA (2) | CA3192910A1 (es) |
| CL (1) | CL2023000961A1 (es) |
| CO (1) | CO2023004265A2 (es) |
| EC (1) | ECSP23024034A (es) |
| IL (2) | IL301572A (es) |
| MX (2) | MX2023003836A (es) |
| PE (1) | PE20231507A1 (es) |
| WO (2) | WO2022072919A1 (es) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111265719B (zh) | 2014-03-21 | 2023-01-10 | 匹兹堡大学-联邦高等教育体系 | 最终消毒的来自细胞外基质的水凝胶的制备方法 |
| US20230406914A1 (en) * | 2020-10-02 | 2023-12-21 | Eli Lilly And Company | Methods for reducing host cell protein content in antibody purification processes and antibody compositions having reduced host cell protein content |
| WO2024068996A1 (en) | 2022-09-30 | 2024-04-04 | Centre Hospitalier Universitaire Vaudois (C.H.U.V.) | Anti-sars-cov-2 antibodies and use thereof in the treatment of sars-cov-2 infection |
| WO2025133047A1 (en) | 2023-12-22 | 2025-06-26 | Novo Nordisk A/S | System and methods for counter-current filtration |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105111309A (zh) * | 2008-10-20 | 2015-12-02 | Abbvie公司 | 使用a蛋白亲和层析分离和纯化抗体 |
| PT3042917T (pt) * | 2010-08-12 | 2018-05-02 | Lilly Co Eli | Anticorpos do péptido beta amilóide anti-n3pglu e seus usos |
| US9499610B2 (en) * | 2011-04-08 | 2016-11-22 | H. Lundbeck A/S | Antibodies specific to pyroglutamated Aβ |
| WO2015175769A1 (en) * | 2014-05-15 | 2015-11-19 | Biogen Ma Inc. | Methods for the detection of amyloid beta oligomers in biological samples |
| US10941178B2 (en) * | 2017-03-17 | 2021-03-09 | Gilead Sciences, Inc. | Method of purifying an antibody |
| JOP20190247A1 (ar) | 2017-04-20 | 2019-10-20 | Lilly Co Eli | أجسام بيتا ببتيد النشوانية المضادة لـ N3pGlu واستخداماتها |
| US10829547B2 (en) * | 2017-10-16 | 2020-11-10 | Eisai R&D Management Co., Ltd. | Anti-tau antibodies and uses thereof |
| US11033714B2 (en) * | 2017-12-15 | 2021-06-15 | Biosense Webster (Israel) Ltd. | Catheter with biased and discrete deflection characteristics and related methods |
| TWI724392B (zh) * | 2018-04-06 | 2021-04-11 | 美商美國禮來大藥廠 | 生長分化因子15促效劑化合物及其使用方法 |
| CR20220552A (es) * | 2020-04-02 | 2023-01-17 | Regeneron Pharma | Anticuerpos contra glicoproteína de espícula anti-sars-cov-2 y fragmentos de unión al antígeno |
| US20230406914A1 (en) * | 2020-10-02 | 2023-12-21 | Eli Lilly And Company | Methods for reducing host cell protein content in antibody purification processes and antibody compositions having reduced host cell protein content |
-
2021
- 2021-10-04 US US18/247,198 patent/US20230406914A1/en active Pending
- 2021-10-04 EP EP21807337.7A patent/EP4222160A1/en active Pending
- 2021-10-04 AU AU2021355518A patent/AU2021355518A1/en active Pending
- 2021-10-04 KR KR1020237011095A patent/KR20230061462A/ko active Pending
- 2021-10-04 EP EP21807334.4A patent/EP4222159A1/en active Pending
- 2021-10-04 CA CA3192910A patent/CA3192910A1/en active Pending
- 2021-10-04 PE PE2023001345A patent/PE20231507A1/es unknown
- 2021-10-04 US US18/247,084 patent/US20230374063A1/en active Pending
- 2021-10-04 WO PCT/US2021/053318 patent/WO2022072919A1/en not_active Ceased
- 2021-10-04 BR BR112023004871A patent/BR112023004871A2/pt unknown
- 2021-10-04 JP JP2023520349A patent/JP7668351B2/ja active Active
- 2021-10-04 MX MX2023003836A patent/MX2023003836A/es unknown
- 2021-10-04 IL IL301572A patent/IL301572A/en unknown
- 2021-10-04 MX MX2023003863A patent/MX2023003863A/es unknown
- 2021-10-04 CA CA3193722A patent/CA3193722A1/en active Pending
- 2021-10-04 WO PCT/US2021/053407 patent/WO2022072934A1/en not_active Ceased
- 2021-10-04 AU AU2021355521A patent/AU2021355521A1/en active Pending
- 2021-10-04 CN CN202180081449.3A patent/CN116547292A/zh active Pending
- 2021-10-04 AR ARP210102747A patent/AR123688A1/es not_active Application Discontinuation
- 2021-10-04 CN CN202180067683.0A patent/CN116348486A/zh active Pending
- 2021-10-04 JP JP2023520389A patent/JP2023544399A/ja active Pending
- 2021-10-04 IL IL301584A patent/IL301584A/en unknown
- 2021-10-04 KR KR1020237014350A patent/KR20230078748A/ko active Pending
-
2023
- 2023-03-31 CO CONC2023/0004265A patent/CO2023004265A2/es unknown
- 2023-03-31 EC ECSENADI202324034A patent/ECSP23024034A/es unknown
- 2023-03-31 CL CL2023000961A patent/CL2023000961A1/es unknown
-
2025
- 2025-08-08 JP JP2025133411A patent/JP2025166120A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20230374063A1 (en) | 2023-11-23 |
| US20230406914A1 (en) | 2023-12-21 |
| JP2023544399A (ja) | 2023-10-23 |
| EP4222159A1 (en) | 2023-08-09 |
| IL301584A (en) | 2023-05-01 |
| WO2022072919A1 (en) | 2022-04-07 |
| AU2021355518A1 (en) | 2023-06-08 |
| BR112023004871A2 (pt) | 2023-04-25 |
| IL301572A (en) | 2023-05-01 |
| TW202229307A (zh) | 2022-08-01 |
| EP4222160A1 (en) | 2023-08-09 |
| CN116547292A (zh) | 2023-08-04 |
| JP7668351B2 (ja) | 2025-04-24 |
| AR123688A1 (es) | 2023-01-04 |
| MX2023003836A (es) | 2023-04-14 |
| CA3193722A1 (en) | 2022-04-07 |
| JP2023545019A (ja) | 2023-10-26 |
| CL2023000961A1 (es) | 2023-11-03 |
| AU2021355518A9 (en) | 2024-02-08 |
| ECSP23024034A (es) | 2023-04-28 |
| KR20230061462A (ko) | 2023-05-08 |
| AU2021355521A1 (en) | 2023-05-11 |
| CO2023004265A2 (es) | 2023-04-27 |
| CA3192910A1 (en) | 2022-04-07 |
| MX2023003863A (es) | 2023-04-14 |
| WO2022072934A1 (en) | 2022-04-07 |
| KR20230078748A (ko) | 2023-06-02 |
| JP2025166120A (ja) | 2025-11-05 |
| CN116348486A (zh) | 2023-06-27 |
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