RU2016104542A - Осуществление оптимизации входных условий ионообменной хроматографии - Google Patents
Осуществление оптимизации входных условий ионообменной хроматографии Download PDFInfo
- Publication number
- RU2016104542A RU2016104542A RU2016104542A RU2016104542A RU2016104542A RU 2016104542 A RU2016104542 A RU 2016104542A RU 2016104542 A RU2016104542 A RU 2016104542A RU 2016104542 A RU2016104542 A RU 2016104542A RU 2016104542 A RU2016104542 A RU 2016104542A
- Authority
- RU
- Russia
- Prior art keywords
- polypeptide
- buffer
- chromatographic material
- antibody
- impurities
- Prior art date
Links
- 238000004255 ion exchange chromatography Methods 0.000 title claims 8
- 238000005457 optimization Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 98
- 229920001184 polypeptide Polymers 0.000 claims 71
- 102000004196 processed proteins & peptides Human genes 0.000 claims 71
- 108090000765 processed proteins & peptides Proteins 0.000 claims 71
- 239000000463 material Substances 0.000 claims 41
- 239000000872 buffer Substances 0.000 claims 31
- 239000012535 impurity Substances 0.000 claims 30
- 239000000203 mixture Substances 0.000 claims 29
- 150000003839 salts Chemical class 0.000 claims 16
- 238000005342 ion exchange Methods 0.000 claims 11
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 10
- 238000004587 chromatography analysis Methods 0.000 claims 10
- 239000012634 fragment Substances 0.000 claims 8
- 239000012160 loading buffer Substances 0.000 claims 8
- 238000005341 cation exchange Methods 0.000 claims 6
- 239000012149 elution buffer Substances 0.000 claims 6
- 238000000926 separation method Methods 0.000 claims 5
- 239000011780 sodium chloride Substances 0.000 claims 5
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 claims 4
- 150000001412 amines Chemical group 0.000 claims 4
- 238000005349 anion exchange Methods 0.000 claims 4
- 150000003512 tertiary amines Chemical class 0.000 claims 4
- 239000007995 HEPES buffer Substances 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 3
- 150000001413 amino acids Chemical class 0.000 claims 3
- 239000007857 degradation product Substances 0.000 claims 3
- 238000010494 dissociation reaction Methods 0.000 claims 3
- 230000005593 dissociations Effects 0.000 claims 3
- DBXNUXBLKRLWFA-UHFFFAOYSA-N N-(2-acetamido)-2-aminoethanesulfonic acid Chemical group NC(=O)CNCCS(O)(=O)=O DBXNUXBLKRLWFA-UHFFFAOYSA-N 0.000 claims 2
- 230000007935 neutral effect Effects 0.000 claims 2
- 239000007991 ACES buffer Substances 0.000 claims 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8658—Optimising operation parameters
-
- 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
- B01D15/362—Cation-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
- B01D15/36—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
- B01D15/363—Anion-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
- B01D15/3847—Multimodal interactions
-
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
Landscapes
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Food Science & Technology (AREA)
- Peptides Or Proteins (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Confectionery (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361845890P | 2013-07-12 | 2013-07-12 | |
| US61/845,890 | 2013-07-12 | ||
| PCT/US2014/046338 WO2015006686A1 (en) | 2013-07-12 | 2014-07-11 | Elucidation of ion exchange chromatography input optimization |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2016104542A true RU2016104542A (ru) | 2017-08-17 |
Family
ID=51257626
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2016104542A RU2016104542A (ru) | 2013-07-12 | 2014-07-11 | Осуществление оптимизации входных условий ионообменной хроматографии |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US10274466B2 (https=) |
| EP (2) | EP3019516B1 (https=) |
| JP (2) | JP6462681B2 (https=) |
| KR (1) | KR102251127B1 (https=) |
| CN (1) | CN105377873B (https=) |
| AU (1) | AU2014287044B2 (https=) |
| BR (1) | BR112016000231A8 (https=) |
| CA (1) | CA2918052A1 (https=) |
| ES (1) | ES2705700T3 (https=) |
| HR (1) | HRP20190071T1 (https=) |
| IL (1) | IL243305B (https=) |
| MX (1) | MX368107B (https=) |
| PL (1) | PL3019516T3 (https=) |
| RU (1) | RU2016104542A (https=) |
| SG (1) | SG11201600221YA (https=) |
| SI (1) | SI3019516T1 (https=) |
| TR (1) | TR201818966T4 (https=) |
| WO (1) | WO2015006686A1 (https=) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2014287044B2 (en) | 2013-07-12 | 2020-02-06 | Genentech, Inc. | Elucidation of ion exchange chromatography input optimization |
| US11460455B2 (en) | 2014-11-12 | 2022-10-04 | Cytiva Sweden Ab | Method and system for determining the influence of experimental parameters on a liquid chromatography protocol |
| GB2539420B (en) * | 2015-06-16 | 2021-01-13 | Cytiva Sweden Ab | Determination of chromatography conditions |
| AU2019246983B2 (en) * | 2018-04-02 | 2025-12-18 | Amgen Inc. | Erenumab compositions and uses thereof |
| WO2020010304A2 (en) * | 2018-07-05 | 2020-01-09 | Ovation Diagnostics Llc | BCl-2 Antibodies and Immunoassay for Diagnosis of Cancer |
| KR20200080748A (ko) * | 2018-12-27 | 2020-07-07 | 주식회사 폴루스 | 음이온 교환 크로마토그래피를 이용한 인슐린 전구체의 정제방법 |
| WO2024261724A1 (en) * | 2023-06-23 | 2024-12-26 | Lupin Limited | Ion-exchange chromatography for separation and analysis of charge variants |
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| AU2014287044B2 (en) | 2013-07-12 | 2020-02-06 | Genentech, Inc. | Elucidation of ion exchange chromatography input optimization |
-
2014
- 2014-07-11 AU AU2014287044A patent/AU2014287044B2/en not_active Ceased
- 2014-07-11 HR HRP20190071TT patent/HRP20190071T1/hr unknown
- 2014-07-11 WO PCT/US2014/046338 patent/WO2015006686A1/en not_active Ceased
- 2014-07-11 MX MX2016000181A patent/MX368107B/es active IP Right Grant
- 2014-07-11 SI SI201431039T patent/SI3019516T1/sl unknown
- 2014-07-11 TR TR2018/18966T patent/TR201818966T4/tr unknown
- 2014-07-11 EP EP14745049.8A patent/EP3019516B1/en active Active
- 2014-07-11 SG SG11201600221YA patent/SG11201600221YA/en unknown
- 2014-07-11 KR KR1020167003178A patent/KR102251127B1/ko not_active Expired - Fee Related
- 2014-07-11 US US14/904,422 patent/US10274466B2/en active Active
- 2014-07-11 CN CN201480039460.3A patent/CN105377873B/zh active Active
- 2014-07-11 EP EP18204792.8A patent/EP3536699A1/en not_active Withdrawn
- 2014-07-11 BR BR112016000231A patent/BR112016000231A8/pt active Search and Examination
- 2014-07-11 JP JP2016525805A patent/JP6462681B2/ja active Active
- 2014-07-11 CA CA2918052A patent/CA2918052A1/en not_active Abandoned
- 2014-07-11 ES ES14745049T patent/ES2705700T3/es active Active
- 2014-07-11 PL PL14745049T patent/PL3019516T3/pl unknown
- 2014-07-11 RU RU2016104542A patent/RU2016104542A/ru not_active Application Discontinuation
-
2015
- 2015-12-23 IL IL243305A patent/IL243305B/en active IP Right Grant
-
2018
- 2018-12-26 JP JP2018242206A patent/JP2019090818A/ja active Pending
-
2019
- 2019-03-12 US US16/351,372 patent/US10921297B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015006686A1 (en) | 2015-01-15 |
| SG11201600221YA (en) | 2016-02-26 |
| CN105377873A (zh) | 2016-03-02 |
| JP2019090818A (ja) | 2019-06-13 |
| HRP20190071T1 (hr) | 2019-02-22 |
| AU2014287044B2 (en) | 2020-02-06 |
| HK1222183A1 (zh) | 2017-06-23 |
| EP3019516A1 (en) | 2016-05-18 |
| US20190310234A1 (en) | 2019-10-10 |
| JP6462681B2 (ja) | 2019-01-30 |
| CN105377873B (zh) | 2021-03-30 |
| IL243305B (en) | 2019-09-26 |
| ES2705700T3 (es) | 2019-03-26 |
| BR112016000231A8 (pt) | 2019-12-31 |
| JP2016529489A (ja) | 2016-09-23 |
| PL3019516T3 (pl) | 2019-04-30 |
| AU2014287044A1 (en) | 2016-02-11 |
| KR20160030251A (ko) | 2016-03-16 |
| EP3019516B1 (en) | 2018-11-14 |
| IL243305A0 (en) | 2016-03-31 |
| US10921297B2 (en) | 2021-02-16 |
| MX368107B (es) | 2019-09-18 |
| US10274466B2 (en) | 2019-04-30 |
| WO2015006686A8 (en) | 2018-10-04 |
| EP3536699A1 (en) | 2019-09-11 |
| US20160161455A1 (en) | 2016-06-09 |
| MX2016000181A (es) | 2016-03-09 |
| CA2918052A1 (en) | 2015-01-15 |
| TR201818966T4 (tr) | 2019-01-21 |
| KR102251127B1 (ko) | 2021-05-11 |
| SI3019516T1 (sl) | 2019-02-28 |
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