JP6925111B2 - 治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤 - Google Patents
治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤 Download PDFInfo
- Publication number
- JP6925111B2 JP6925111B2 JP2016181594A JP2016181594A JP6925111B2 JP 6925111 B2 JP6925111 B2 JP 6925111B2 JP 2016181594 A JP2016181594 A JP 2016181594A JP 2016181594 A JP2016181594 A JP 2016181594A JP 6925111 B2 JP6925111 B2 JP 6925111B2
- Authority
- JP
- Japan
- Prior art keywords
- excipient
- protein
- concentration
- solution
- diafiltration
- 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.)
- Active
Links
- 102000004169 proteins and genes Human genes 0.000 title claims description 118
- 108090000623 proteins and genes Proteins 0.000 title claims description 118
- 238000000034 method Methods 0.000 title claims description 96
- 238000002360 preparation method Methods 0.000 title claims description 36
- 230000001225 therapeutic effect Effects 0.000 title claims description 8
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 118
- 239000000243 solution Substances 0.000 claims description 107
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 59
- 238000000108 ultra-filtration Methods 0.000 claims description 48
- 238000011026 diafiltration Methods 0.000 claims description 31
- 239000000872 buffer Substances 0.000 claims description 28
- 238000009472 formulation Methods 0.000 claims description 23
- 239000000203 mixture Substances 0.000 claims description 23
- 239000012538 diafiltration buffer Substances 0.000 claims description 20
- 230000014759 maintenance of location Effects 0.000 claims description 19
- 229930006000 Sucrose Natural products 0.000 claims description 18
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 18
- 239000005720 sucrose Substances 0.000 claims description 18
- 239000004475 Arginine Substances 0.000 claims description 17
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 17
- 239000007788 liquid Substances 0.000 claims description 14
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 12
- 239000000654 additive Substances 0.000 claims description 12
- 230000000996 additive effect Effects 0.000 claims description 12
- 238000010790 dilution Methods 0.000 claims description 11
- 239000012895 dilution Substances 0.000 claims description 11
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 8
- 229920000053 polysorbate 80 Polymers 0.000 claims description 8
- 229940068968 polysorbate 80 Drugs 0.000 claims description 8
- 235000000346 sugar Nutrition 0.000 claims description 8
- 150000001413 amino acids Chemical group 0.000 claims description 6
- 238000011084 recovery Methods 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 4
- 239000002738 chelating agent Substances 0.000 claims description 3
- 125000000600 disaccharide group Chemical group 0.000 claims 1
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 43
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 43
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 43
- 238000002474 experimental method Methods 0.000 description 26
- 239000000047 product Substances 0.000 description 25
- 125000003275 alpha amino acid group Chemical group 0.000 description 15
- 239000000463 material Substances 0.000 description 14
- 239000012528 membrane Substances 0.000 description 14
- 229940088679 drug related substance Drugs 0.000 description 9
- 102100035360 Cerebellar degeneration-related antigen 1 Human genes 0.000 description 8
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 8
- 239000008186 active pharmaceutical agent Substances 0.000 description 8
- 238000007796 conventional method Methods 0.000 description 7
- 230000004907 flux Effects 0.000 description 7
- 239000007858 starting material Substances 0.000 description 7
- 239000012530 fluid Substances 0.000 description 6
- 229920000136 polysorbate Polymers 0.000 description 6
- 229950008882 polysorbate Drugs 0.000 description 6
- 238000011020 pilot scale process Methods 0.000 description 5
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 230000002776 aggregation Effects 0.000 description 4
- 238000013467 fragmentation Methods 0.000 description 4
- 238000006062 fragmentation reaction Methods 0.000 description 4
- 239000004627 regenerated cellulose Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 238000004220 aggregation Methods 0.000 description 3
- 239000012471 diafiltration solution Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- -1 histidine Chemical class 0.000 description 3
- 239000012516 mab select resin Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000005086 pumping Methods 0.000 description 3
- 238000000746 purification Methods 0.000 description 3
- 108010047041 Complementarity Determining Regions Proteins 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000013020 final formulation Substances 0.000 description 2
- 108040006861 interleukin-7 receptor activity proteins Proteins 0.000 description 2
- 238000011165 process development Methods 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 239000012460 protein solution Substances 0.000 description 2
- 239000013014 purified material Substances 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 150000008163 sugars Chemical class 0.000 description 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 241000473391 Archosargus rhomboidalis Species 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 101710172072 Kexin Proteins 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000007983 Tris buffer Substances 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000004520 agglutination Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 229960004539 alirocumab Drugs 0.000 description 1
- 238000012801 analytical assay Methods 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000008033 biological extinction Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000012468 concentrated sample Substances 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 150000002016 disaccharides Chemical class 0.000 description 1
- 238000010889 donnan-equilibrium Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 229960002027 evolocumab Drugs 0.000 description 1
- 238000013401 experimental design Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000012537 formulation buffer Substances 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000011140 membrane chromatography Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 229940028952 praluent Drugs 0.000 description 1
- 230000029983 protein stabilization Effects 0.000 description 1
- 229940124272 protein stabilizer Drugs 0.000 description 1
- 230000003134 recirculating effect Effects 0.000 description 1
- 229940017164 repatha Drugs 0.000 description 1
- 238000001226 reprecipitation Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 239000012465 retentate Substances 0.000 description 1
- 239000012487 rinsing solution Substances 0.000 description 1
- 238000013341 scale-up Methods 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229940126622 therapeutic monoclonal antibody Drugs 0.000 description 1
- 238000010977 unit operation Methods 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
-
- 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
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Organic Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Cell Biology (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Food Science & Technology (AREA)
- Biotechnology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562222067P | 2015-09-22 | 2015-09-22 | |
| US62/222067 | 2015-09-22 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017095440A JP2017095440A (ja) | 2017-06-01 |
| JP2017095440A5 JP2017095440A5 (enExample) | 2019-10-24 |
| JP6925111B2 true JP6925111B2 (ja) | 2021-08-25 |
Family
ID=57045234
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016181594A Active JP6925111B2 (ja) | 2015-09-22 | 2016-09-16 | 治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤 |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20230134160A1 (enExample) |
| EP (1) | EP3352790A1 (enExample) |
| JP (1) | JP6925111B2 (enExample) |
| KR (2) | KR20200035496A (enExample) |
| CN (1) | CN108025072A (enExample) |
| AU (1) | AU2016329034B2 (enExample) |
| CA (1) | CA2999118C (enExample) |
| HK (1) | HK1255006A1 (enExample) |
| IL (1) | IL258311B (enExample) |
| MX (1) | MX2018003298A (enExample) |
| WO (1) | WO2017051273A1 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019517473A (ja) | 2016-05-27 | 2019-06-24 | アレクシオン ファーマシューティカルズ インコーポレイテッドAlexion Pharmaceuticals, Inc. | 難治性全身型重症筋無力症の処置のための方法 |
| KR20200070355A (ko) | 2017-10-26 | 2020-06-17 | 알렉시온 파마슈티칼스, 인코포레이티드 | 발작성 야간 혈색소뇨 (pnh) 및 비정형 용혈성 요독 증후군 (ahus)의 치료를 위한 항-c5 항체의 투여량 및 투여 |
| CN112088013B (zh) * | 2018-03-26 | 2024-12-06 | 勃林格殷格翰动物保健美国有限公司 | 制备免疫原性组合物的方法 |
| NZ770284A (en) | 2018-05-10 | 2025-11-28 | Regeneron Pharma | High concentration vegf receptor fusion protein containing formulations |
| WO2020006266A1 (en) * | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| EP3837273B1 (en) * | 2018-08-14 | 2025-09-24 | Bristol-Myers Squibb Company | Improved protein recovery |
| CN111110841A (zh) * | 2018-10-31 | 2020-05-08 | 上海君实生物医药科技股份有限公司 | 含有抗pcsk9抗体的稳定制剂 |
| EP3782666B1 (en) | 2019-01-24 | 2021-08-11 | Magenta Medical Ltd. | Manufacturing an impeller |
| TWI871300B (zh) * | 2019-01-28 | 2025-02-01 | 美商安進公司 | 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程 |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| WO2021171310A1 (en) * | 2020-02-24 | 2021-09-02 | Indian Institute Of Technology Delhi | A system for real-time monitoring of protein and excipients |
| CN111944046B (zh) * | 2020-08-28 | 2021-04-09 | 江苏荃信生物医药有限公司 | 高浓度、低粘度抗人il-23单克隆抗体溶液的制备方法 |
| WO2022041390A1 (zh) * | 2020-08-28 | 2022-03-03 | 江苏荃信生物医药股份有限公司 | 包含高浓度抗人白介素23单克隆抗体的低粘度液体制剂及其制备方法 |
| KR20230127292A (ko) * | 2020-12-30 | 2023-08-31 | 아이-맵 바이오파마 컴파니 리미티드 | 항-cd73 항체의 제제 |
| CN114014929B (zh) * | 2021-11-04 | 2022-07-19 | 江苏荃信生物医药股份有限公司 | 一种抗人白介素-33单克隆抗体浓缩溶液的制备方法 |
| JP2025530825A (ja) | 2022-09-14 | 2025-09-17 | マジェンタ・メディカル・リミテッド | 心室補助デバイスの湾曲 |
| WO2024165043A1 (en) * | 2023-02-08 | 2024-08-15 | Beigene Switzerland Gmbh | Preparation methods for a highly concentrated pd1 antibody solution by applying single-pass tangential flow filtration (sptff) |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9415102B2 (en) * | 2002-09-06 | 2016-08-16 | Alexion Pharmaceuticals, Inc. | High concentration formulations of anti-C5 antibodies |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| DK1865986T3 (en) * | 2005-03-08 | 2016-04-11 | Pfizer Prod Inc | The anti-CTLA-4 antibody compositions |
| CN101553504A (zh) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| WO2010042705A1 (en) * | 2008-10-09 | 2010-04-15 | Medimmune, Llc | Antibody formulation |
| US8298535B2 (en) * | 2010-02-24 | 2012-10-30 | Rinat Neuroscience Corp. | Anti-IL-7 receptor antibodies |
| EA022220B1 (ru) * | 2010-02-24 | 2015-11-30 | Сюменекс А/С | Способ получения и очистки рекомбинантной лизосомальной альфа-маннозидазы |
| WO2012168491A1 (en) * | 2011-06-10 | 2012-12-13 | Novartis Ag | Pharmaceutical formulations of pcsk9 antagonists |
| EP2583980A1 (en) * | 2011-10-19 | 2013-04-24 | Effimune | Antibodies directed against the alpha chain of IL7 receptor - their use for the preparation of drug candidates |
| BR112014028129A2 (pt) * | 2012-05-14 | 2017-06-27 | Novo Nordisk As | soluções de proteína estabilizadas |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| EP2727602A1 (en) * | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
-
2016
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en active Active
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en not_active Ceased
- 2016-09-08 HK HK18114122.2A patent/HK1255006A1/zh unknown
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-08 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko not_active Ceased
- 2016-09-08 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-16 JP JP2016181594A patent/JP6925111B2/ja active Active
-
2018
- 2018-03-22 IL IL258311A patent/IL258311B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| WO2017051273A1 (en) | 2017-03-30 |
| EP3352790A1 (en) | 2018-08-01 |
| US20230134160A1 (en) | 2023-05-04 |
| KR20200035496A (ko) | 2020-04-03 |
| IL258311A (en) | 2018-05-31 |
| JP2017095440A (ja) | 2017-06-01 |
| AU2016329034B2 (en) | 2019-05-23 |
| CA2999118A1 (en) | 2017-03-30 |
| IL258311B (en) | 2021-04-29 |
| KR20180037056A (ko) | 2018-04-10 |
| HK1255006A1 (zh) | 2019-08-02 |
| RU2018110145A3 (enExample) | 2020-02-10 |
| CN108025072A (zh) | 2018-05-11 |
| AU2016329034A1 (en) | 2018-03-15 |
| MX2018003298A (es) | 2018-06-20 |
| RU2018110145A (ru) | 2019-10-23 |
| CA2999118C (en) | 2022-06-14 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP6925111B2 (ja) | 治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤 | |
| EP2892504B1 (fr) | Solution aqueuse de protéine à concentration élevée de viscosité réduite | |
| CN105175548B (zh) | 重组人血管内皮生长因子受体-抗体融合蛋白的纯化方法 | |
| JP7114567B2 (ja) | 生体分子を含む高濃縮液体製剤の調製のためのプロセス | |
| US20160251441A1 (en) | Antibody purification | |
| EA023446B1 (ru) | СПОСОБ ПОЛУЧЕНИЯ ОБОГАЩЕННОЙ IgG-КОМПОЗИЦИИ ИЗ ПЛАЗМЫ | |
| JP2020033361A (ja) | 液体医薬組成物 | |
| JP2017516848A (ja) | 液体医薬組成物 | |
| KR20220156534A (ko) | 고농도 항-Aβ 프로토피브릴 항체 제형물 및 이의 사용 방법 | |
| JP2021524470A (ja) | 安定な融合タンパク質製剤 | |
| US20230279146A1 (en) | Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations | |
| JP2021525255A (ja) | CTLA4−Ig融合タンパク質製剤 | |
| CN114423414A (zh) | 樟脑磺酸及其与阳离子赋形剂的组合作为高浓缩蛋白质制剂中的降粘剂 | |
| EP4094777A1 (en) | Recombinant fully human anti-tigit monoclonal antibody preparations, preparation method therefor and use thereof | |
| US12466882B2 (en) | Pharmaceutical formulations for adalimumab | |
| RU2779389C2 (ru) | Способ получения терапевтического белкового препарата и препарат на основе антител, полученный по такому способу | |
| JP2022508595A (ja) | クロマトグラフィーを含まない抗体精製方法 | |
| US20240374720A1 (en) | Antibody formulations and uses thereof | |
| JP7170983B2 (ja) | 改善された保存安定性を有するタンパク質含有液体製剤およびその製造方法 | |
| KR20220075380A (ko) | 단백질 정제 및 바이러스 불활성화 | |
| KR20250043468A (ko) | 고도로 농축된 핵산 조성물을 위한 점도 감소 부형제 및 이의 조합물 | |
| Rosenberg | Aggregation of therapeutic antibodies in the course of downstream processing |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20190911 |
|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20190911 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20201124 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20210218 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20210315 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20210427 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20210604 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20210727 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20210803 |
|
| R150 | Certificate of patent or registration of utility model |
Ref document number: 6925111 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |