JP2011530524A5 - - Google Patents
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- Publication number
- JP2011530524A5 JP2011530524A5 JP2011522218A JP2011522218A JP2011530524A5 JP 2011530524 A5 JP2011530524 A5 JP 2011530524A5 JP 2011522218 A JP2011522218 A JP 2011522218A JP 2011522218 A JP2011522218 A JP 2011522218A JP 2011530524 A5 JP2011530524 A5 JP 2011530524A5
- Authority
- JP
- Japan
- Prior art keywords
- substance
- stabilizer
- temperature
- pharmaceutical substance
- liquid formulation
- 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
Links
- 238000000034 method Methods 0.000 claims 43
- 239000003814 drug Substances 0.000 claims 15
- 239000003381 stabilizer Substances 0.000 claims 10
- 239000012669 liquid formulation Substances 0.000 claims 9
- 102000004169 proteins and genes Human genes 0.000 claims 9
- 108090000623 proteins and genes Proteins 0.000 claims 9
- 239000008186 active pharmaceutical agent Substances 0.000 claims 6
- 229940088679 drug related substance Drugs 0.000 claims 6
- 239000000463 material Substances 0.000 claims 6
- 239000012907 medicinal substance Substances 0.000 claims 6
- 150000004676 glycans Chemical class 0.000 claims 5
- 229920001282 polysaccharide Polymers 0.000 claims 5
- 239000005017 polysaccharide Substances 0.000 claims 5
- 230000009477 glass transition Effects 0.000 claims 4
- 102000015081 Blood Coagulation Factors Human genes 0.000 claims 3
- 108010039209 Blood Coagulation Factors Proteins 0.000 claims 3
- 102000014914 Carrier Proteins Human genes 0.000 claims 3
- 108010078791 Carrier Proteins Proteins 0.000 claims 3
- 102000004127 Cytokines Human genes 0.000 claims 3
- 108090000695 Cytokines Proteins 0.000 claims 3
- 102000004190 Enzymes Human genes 0.000 claims 3
- 108090000790 Enzymes Proteins 0.000 claims 3
- 239000003114 blood coagulation factor Substances 0.000 claims 3
- 150000001875 compounds Chemical class 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 3
- 239000012634 fragment Substances 0.000 claims 3
- 102000037865 fusion proteins Human genes 0.000 claims 3
- 108020001507 fusion proteins Proteins 0.000 claims 3
- 239000003102 growth factor Substances 0.000 claims 3
- 229930014626 natural product Natural products 0.000 claims 3
- 102000039446 nucleic acids Human genes 0.000 claims 3
- 108020004707 nucleic acids Proteins 0.000 claims 3
- 150000007523 nucleic acids Chemical class 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims 3
- 102000004196 processed proteins & peptides Human genes 0.000 claims 3
- 150000003384 small molecules Chemical class 0.000 claims 3
- 229960005486 vaccine Drugs 0.000 claims 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 108010003723 Single-Domain Antibodies Proteins 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 239000008177 pharmaceutical agent Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 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 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 239000004475 Arginine Substances 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- 229920001612 Hydroxyethyl starch Polymers 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 claims 1
- 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 1
- 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 claims 1
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 claims 1
- 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 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 230000005496 eutectics Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229940050526 hydroxyethylstarch Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose 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[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 claims 1
- 230000001172 regenerating effect Effects 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8642608P | 2008-08-05 | 2008-08-05 | |
| US61/086,426 | 2008-08-05 | ||
| PCT/US2009/052852 WO2010017296A1 (en) | 2008-08-05 | 2009-08-05 | Lyophilization above collapse |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2011530524A JP2011530524A (ja) | 2011-12-22 |
| JP2011530524A5 true JP2011530524A5 (enExample) | 2012-09-13 |
| JP5785077B2 JP5785077B2 (ja) | 2015-09-24 |
Family
ID=41401614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011522218A Active JP5785077B2 (ja) | 2008-08-05 | 2009-08-05 | 崩壊温度より高温での凍結乾燥 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US9884019B2 (enExample) |
| EP (2) | EP2323629B1 (enExample) |
| JP (1) | JP5785077B2 (enExample) |
| CA (1) | CA2729972C (enExample) |
| ES (2) | ES2755029T3 (enExample) |
| WO (1) | WO2010017296A1 (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2007305255A1 (en) * | 2006-10-03 | 2008-04-10 | Wyeth | Lyophilization methods and apparatuses |
| AU2007234612B2 (en) * | 2006-12-14 | 2013-06-27 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein stabilization formulations |
| US7678764B2 (en) | 2007-06-29 | 2010-03-16 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein formulations for use at elevated temperatures |
| US8058237B2 (en) | 2007-08-07 | 2011-11-15 | Advanced Technologies & Regenerative Medicine, LLC | Stable composition of GDF-5 and method of storage |
| CN102026619A (zh) * | 2008-04-14 | 2011-04-20 | 先进科技及再生医学有限责任公司 | 液体缓冲的gdf-5制剂 |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
| CN105189559B (zh) | 2013-03-15 | 2021-07-13 | 塔科达有限责任公司 | 抗体制剂及其用途 |
| WO2014144549A1 (en) | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| SG10201913735SA (en) | 2014-03-24 | 2020-03-30 | Bioverativ Therapeutics Inc | Lyophilized factor ix formulations |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| EP3323410A1 (en) * | 2016-11-22 | 2018-05-23 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.a. | Pharmaceutical parenteral formulation containing carglumic acid |
| CN107543373B (zh) * | 2017-09-06 | 2019-04-26 | 华派生物工程集团有限公司 | 一种活疫苗的冷冻干燥方法 |
| KR20210021299A (ko) | 2018-05-10 | 2021-02-25 | 리제너론 파아마슈티컬스, 인크. | 고농도 vegf 수용체 융합 단백질 함유 제제 |
| CN109369821B (zh) * | 2018-11-28 | 2021-12-14 | 四川恒通动保生物科技有限公司 | 一种黄芪多糖的高效提取制备方法 |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| US11525629B2 (en) * | 2020-02-04 | 2022-12-13 | Regeneron Pharmaceuticals, Inc. | Target residual moisture content for lyophilized drug product |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5298261A (en) | 1992-04-20 | 1994-03-29 | Oregon Freeze Dry, Inc. | Rapidly distintegrating tablet |
| BR9507909A (pt) * | 1994-06-03 | 1997-08-12 | Procter & Gamble | Formas de dosagem de rápida dissolução |
| RU2111426C1 (ru) | 1995-11-03 | 1998-05-20 | Государственный научный центр вирусологии и биотехнологии "Вектор" | Способ лиофильной сушки биопрепарата |
| ES2253877T3 (es) | 1998-03-03 | 2006-06-01 | SHIONOGI & CO., LTD. | Composiciones farmaceuticas que contienen el inhibidor de fosfolipasa((3-(2-amino-1,2-dioxoetil)-2-etil-1-(fenilmetil)-1h-indol-4-il)oxi)acetato de sodio. |
| EP2193809B1 (en) * | 1999-02-22 | 2015-04-08 | University of Connecticut | Albumin-free factor VIII formulations |
| GB9908014D0 (en) * | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
| GB0404586D0 (en) * | 2004-03-01 | 2004-04-07 | Britannia Pharmaceuticals Ltd | Improvements in or relating to organic materials |
| CA2569276C (en) | 2004-06-02 | 2018-01-23 | Victor Bronshtein | Preservation by vaporization |
| US7632491B2 (en) * | 2004-08-12 | 2009-12-15 | Schering Corporation | Stable pegylated interferon formulation |
| WO2006029467A1 (en) * | 2004-09-16 | 2006-03-23 | Btf Pty Ltd | Rapid freeze drying process |
| WO2006081320A2 (en) | 2005-01-27 | 2006-08-03 | Human Genome Sciences, Inc. | Pharmaceutical formulation |
| CN101378782A (zh) * | 2005-12-21 | 2009-03-04 | 惠氏公司 | 粘度降低的蛋白质制剂及其用途 |
| CA2726837A1 (en) | 2008-06-26 | 2009-12-30 | Wyeth Llc | Lyophilization cycle robustness strategy |
| CA2729972C (en) | 2008-08-05 | 2018-11-20 | Wyeth Llc | Lyophilization above collapse |
-
2009
- 2009-08-05 CA CA2729972A patent/CA2729972C/en active Active
- 2009-08-05 EP EP09791186.1A patent/EP2323629B1/en active Active
- 2009-08-05 ES ES09791186T patent/ES2755029T3/es active Active
- 2009-08-05 US US12/536,321 patent/US9884019B2/en active Active
- 2009-08-05 WO PCT/US2009/052852 patent/WO2010017296A1/en not_active Ceased
- 2009-08-05 ES ES19181153T patent/ES2968301T3/es active Active
- 2009-08-05 EP EP19181153.8A patent/EP3572073B1/en not_active Revoked
- 2009-08-05 JP JP2011522218A patent/JP5785077B2/ja active Active
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