JP2017506218A5 - - Google Patents
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- JP2017506218A5 JP2017506218A5 JP2016546971A JP2016546971A JP2017506218A5 JP 2017506218 A5 JP2017506218 A5 JP 2017506218A5 JP 2016546971 A JP2016546971 A JP 2016546971A JP 2016546971 A JP2016546971 A JP 2016546971A JP 2017506218 A5 JP2017506218 A5 JP 2017506218A5
- Authority
- JP
- Japan
- Prior art keywords
- chromatography
- mccs
- recombinant
- proteins
- chromatographic
- 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.)
- Granted
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- 238000004587 chromatography analysis Methods 0.000 description 13
- 239000012528 membrane Substances 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 238000010977 unit operation Methods 0.000 description 8
- 229960000160 recombinant therapeutic protein Drugs 0.000 description 6
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 description 5
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 description 5
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 108090000790 Enzymes Proteins 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 2
- 108010021625 Immunoglobulin Fragments Proteins 0.000 description 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 2
- 108010005716 Interferon beta-1a Proteins 0.000 description 2
- 108060008682 Tumor Necrosis Factor Proteins 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 102000036639 antigens Human genes 0.000 description 2
- 108091007433 antigens Proteins 0.000 description 2
- 238000004440 column chromatography Methods 0.000 description 2
- 229940088598 enzyme Drugs 0.000 description 2
- 108010039650 imiglucerase Proteins 0.000 description 2
- 229960004461 interferon beta-1a Drugs 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 229960001972 panitumumab Drugs 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 229960003989 tocilizumab Drugs 0.000 description 2
- 102000003390 tumor necrosis factor Human genes 0.000 description 2
- 102100022641 Coagulation factor IX Human genes 0.000 description 1
- 102100026735 Coagulation factor VIII Human genes 0.000 description 1
- 108010019673 Darbepoetin alfa Proteins 0.000 description 1
- 108010074604 Epoetin Alfa Proteins 0.000 description 1
- 108010008165 Etanercept Proteins 0.000 description 1
- 108010076282 Factor IX Proteins 0.000 description 1
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 description 1
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 description 1
- 108010093031 Galactosidases Proteins 0.000 description 1
- 102000002464 Galactosidases Human genes 0.000 description 1
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 1
- 101000987586 Homo sapiens Eosinophil peroxidase Proteins 0.000 description 1
- 101000920686 Homo sapiens Erythropoietin Proteins 0.000 description 1
- 101001018026 Homo sapiens Lysosomal alpha-glucosidase Proteins 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 102000006496 Immunoglobulin Heavy Chains Human genes 0.000 description 1
- 108010019476 Immunoglobulin Heavy Chains Proteins 0.000 description 1
- 102000013463 Immunoglobulin Light Chains Human genes 0.000 description 1
- 108010065825 Immunoglobulin Light Chains Proteins 0.000 description 1
- 102000006992 Interferon-alpha Human genes 0.000 description 1
- 108010047761 Interferon-alpha Proteins 0.000 description 1
- 108090000467 Interferon-beta Proteins 0.000 description 1
- 102000003996 Interferon-beta Human genes 0.000 description 1
- 102000009151 Luteinizing Hormone Human genes 0.000 description 1
- 108010073521 Luteinizing Hormone Proteins 0.000 description 1
- 102100033342 Lysosomal acid glucosylceramidase Human genes 0.000 description 1
- 208000015439 Lysosomal storage disease Diseases 0.000 description 1
- 108010039185 Tenecteplase Proteins 0.000 description 1
- 108090000373 Tissue Plasminogen Activator Proteins 0.000 description 1
- 102000003978 Tissue Plasminogen Activator Human genes 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 229950005186 abagovomab Drugs 0.000 description 1
- 229960003697 abatacept Drugs 0.000 description 1
- 229960000446 abciximab Drugs 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 229960002964 adalimumab Drugs 0.000 description 1
- 229950009084 adecatumumab Drugs 0.000 description 1
- 229960004470 agalsidase beta Drugs 0.000 description 1
- 108010056760 agalsidase beta Proteins 0.000 description 1
- 108010030291 alpha-Galactosidase Proteins 0.000 description 1
- 102000005840 alpha-Galactosidase Human genes 0.000 description 1
- 229960003318 alteplase Drugs 0.000 description 1
- 229950009106 altumomab Drugs 0.000 description 1
- 230000000890 antigenic effect Effects 0.000 description 1
- 229950003145 apolizumab Drugs 0.000 description 1
- 229950005122 atinumab Drugs 0.000 description 1
- 229940049197 cerezyme Drugs 0.000 description 1
- 229940105774 coagulation factor ix Drugs 0.000 description 1
- 229960005029 darbepoetin alfa Drugs 0.000 description 1
- 108010067396 dornase alfa Proteins 0.000 description 1
- 229960001776 edrecolomab Drugs 0.000 description 1
- 229960000284 efalizumab Drugs 0.000 description 1
- KUBARPMUNHKBIQ-VTHUDJRQSA-N eliglustat tartrate Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.C([C@@H](NC(=O)CCCCCCC)[C@H](O)C=1C=C2OCCOC2=CC=1)N1CCCC1.C([C@@H](NC(=O)CCCCCCC)[C@H](O)C=1C=C2OCCOC2=CC=1)N1CCCC1 KUBARPMUNHKBIQ-VTHUDJRQSA-N 0.000 description 1
- 229960003388 epoetin alfa Drugs 0.000 description 1
- 229950008579 ertumaxomab Drugs 0.000 description 1
- 229960000403 etanercept Drugs 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229940028334 follicle stimulating hormone Drugs 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 229960005390 galsulfase Drugs 0.000 description 1
- 108010089296 galsulfase Proteins 0.000 description 1
- 229960001743 golimumab Drugs 0.000 description 1
- 102000044890 human EPO Human genes 0.000 description 1
- 102000045921 human GAA Human genes 0.000 description 1
- 229960002127 imiglucerase Drugs 0.000 description 1
- 230000002163 immunogen Effects 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 229940072221 immunoglobulins Drugs 0.000 description 1
- 229960000598 infliximab Drugs 0.000 description 1
- 229960002486 laronidase Drugs 0.000 description 1
- 229940103023 myozyme Drugs 0.000 description 1
- 229960005027 natalizumab Drugs 0.000 description 1
- 229960000470 omalizumab Drugs 0.000 description 1
- 229960000402 palivizumab Drugs 0.000 description 1
- 229960002087 pertuzumab Drugs 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 229960003876 ranibizumab Drugs 0.000 description 1
- 229960004641 rituximab Drugs 0.000 description 1
- 229960000216 tenecteplase Drugs 0.000 description 1
- 229960000575 trastuzumab Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461928906P | 2014-01-17 | 2014-01-17 | |
| US61/928,906 | 2014-01-17 | ||
| PCT/US2015/011698 WO2015109146A1 (en) | 2014-01-17 | 2015-01-16 | Sterile chromatography and manufacturing processes |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020070132A Division JP7055161B2 (ja) | 2014-01-17 | 2020-04-09 | 無菌クロマトグラフィーおよび製造方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017506218A JP2017506218A (ja) | 2017-03-02 |
| JP2017506218A5 true JP2017506218A5 (2) | 2018-02-08 |
| JP6691047B2 JP6691047B2 (ja) | 2020-04-28 |
Family
ID=52630479
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016546971A Active JP6691047B2 (ja) | 2014-01-17 | 2015-01-16 | 無菌クロマトグラフィーおよび製造方法 |
| JP2020070132A Active JP7055161B2 (ja) | 2014-01-17 | 2020-04-09 | 無菌クロマトグラフィーおよび製造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020070132A Active JP7055161B2 (ja) | 2014-01-17 | 2020-04-09 | 無菌クロマトグラフィーおよび製造方法 |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US10087214B2 (2) |
| EP (1) | EP3094640B1 (2) |
| JP (2) | JP6691047B2 (2) |
| KR (1) | KR102326354B1 (2) |
| CN (1) | CN106103464B (2) |
| AU (1) | AU2015206422B2 (2) |
| BR (1) | BR112016016329B1 (2) |
| CA (1) | CA2936951C (2) |
| CY (1) | CY1124062T1 (2) |
| DK (1) | DK3094640T3 (2) |
| ES (1) | ES2841141T3 (2) |
| HK (1) | HK1227042B (2) |
| HU (1) | HUE052611T2 (2) |
| IL (1) | IL246774B (2) |
| MX (1) | MX376882B (2) |
| RU (1) | RU2679133C2 (2) |
| SG (1) | SG11201605626SA (2) |
| TW (2) | TWI709570B (2) |
| WO (1) | WO2015109146A1 (2) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG10201806083RA (en) | 2013-02-22 | 2018-08-30 | Genzyme Corp | Microcarrier perfusion culturing methods and uses thereof |
| HUE042094T2 (hu) | 2013-02-22 | 2019-06-28 | Genzyme Corp | Mikrokarrier-perfúziós tenyésztési eljárások és alkalmazásuk |
| AU2014226126B2 (en) | 2013-03-08 | 2019-02-14 | Genzyme Corporation | Continuous purification of therapeutic proteins |
| TWI709569B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析樹脂及其用於製造方法的用途 |
| TWI709570B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析法及製法 |
| TWI743024B (zh) | 2014-06-06 | 2021-10-21 | 美商健臻公司 | 灌注培養方法及其用途 |
| TWI707949B (zh) | 2014-06-09 | 2020-10-21 | 美商健臻公司 | 種子罐培養法（ｓｅｅｄ ｔｒａｉｎ ｐｒｏｃｅｓｓｅｓ）及其用途 |
| SG10202001034PA (en) | 2014-12-22 | 2020-04-29 | Genzyme Corp | Methods of culturing a mammalian cell |
| DE102015005244A1 (de) * | 2015-04-24 | 2016-11-10 | Sartorius Stedim Biotech Gmbh | Verfahren zur Sterilisierung eines Chromatographiematerials und danach sterilisiertes Chromatographiematerial |
| GB201711249D0 (en) * | 2017-07-13 | 2017-08-30 | Ge Healthcare Bioprocess R&D Ab | Chromatography column |
| ES2991988T3 (es) | 2017-10-30 | 2024-12-05 | Takeda Pharmaceuticals Co | Detergentes compatibles con el medio ambiente para la inactivación de virus con envoltura lipídica |
| JP7165210B2 (ja) * | 2018-05-24 | 2022-11-02 | シグマ－アルドリッチ・カンパニー・リミテッド・ライアビリティ・カンパニー | タンパク質の定量分析 |
| AU2019332764B2 (en) | 2018-08-31 | 2025-05-29 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| US11912741B2 (en) * | 2019-04-03 | 2024-02-27 | Genzyme Corporation | Continuous production of recombinant proteins |
| TW202134631A (zh) | 2019-10-22 | 2021-09-16 | 美商健臻公司 | 整合式連續生物製造中的線上產品監測 |
| CN115475258A (zh) * | 2022-09-06 | 2022-12-16 | 江苏丰华生物制药有限公司 | 一种注射用替奈普酶纯化工艺 |
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