JP2015511129A - 高濃度乾燥タンパク質製剤のための再構成方法 - Google Patents
高濃度乾燥タンパク質製剤のための再構成方法 Download PDFInfo
- Publication number
- JP2015511129A JP2015511129A JP2014548210A JP2014548210A JP2015511129A JP 2015511129 A JP2015511129 A JP 2015511129A JP 2014548210 A JP2014548210 A JP 2014548210A JP 2014548210 A JP2014548210 A JP 2014548210A JP 2015511129 A JP2015511129 A JP 2015511129A
- Authority
- JP
- Japan
- Prior art keywords
- reconstitution
- protein
- dry
- solution
- container
- 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.)
- Pending
Links
Classifications
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/38—Albumins
- A61K38/385—Serum albumin
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Degasification And Air Bubble Elimination (AREA)
- Mixers With Rotating Receptacles And Mixers With Vibration Mechanisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1122430.0 | 2011-12-23 | ||
| GBGB1122430.0A GB201122430D0 (en) | 2011-12-23 | 2011-12-23 | Reconstitution method for high concentration dry protein formulation |
| PCT/GB2012/053266 WO2013093525A1 (en) | 2011-12-23 | 2012-12-24 | Reconstitution method for high concentration dry protein formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2015511129A true JP2015511129A (ja) | 2015-04-16 |
Family
ID=45695059
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014548210A Pending JP2015511129A (ja) | 2011-12-23 | 2012-12-24 | 高濃度乾燥タンパク質製剤のための再構成方法 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20140308293A1 (enExample) |
| EP (1) | EP2793852A1 (enExample) |
| JP (1) | JP2015511129A (enExample) |
| BR (1) | BR112014015605A2 (enExample) |
| CA (1) | CA2859287A1 (enExample) |
| GB (1) | GB201122430D0 (enExample) |
| IN (1) | IN2014MN01381A (enExample) |
| WO (1) | WO2013093525A1 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201313368D0 (en) | 2013-07-26 | 2013-09-11 | Xstalbio Ltd | Novel Reconstitution devices |
| US20170274012A1 (en) * | 2014-09-03 | 2017-09-28 | Entegrion, Inc. | Acceleration of Reconstitution of Plasma Powder by Mixing with Small Beads |
| US10143625B2 (en) | 2015-03-17 | 2018-12-04 | Recon Therapeutics, Inc. | Pharmaceutical reconstitution |
| CN118085011A (zh) | 2016-08-17 | 2024-05-28 | 勃林格殷格翰国际公司 | 制备含有生物分子的高度浓缩的液体制剂的方法 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04502770A (ja) * | 1989-04-10 | 1992-05-21 | コーブ ラボラトリーズ インコーポレイテッド | 新規な凍結乾燥及び再形成赤血球組成物 |
| JPH07304658A (ja) * | 1994-05-06 | 1995-11-21 | Immuno Ag | 血液凝固疾患の治療のための安定な調製物 |
| JP2008231091A (ja) * | 2006-12-14 | 2008-10-02 | Johnson & Johnson Regenerative Therapeutics Llc | タンパク質安定化調合物 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10211227A1 (de) * | 2002-03-13 | 2003-10-02 | Aventis Behring Gmbh | Verfahren zur Rekonstitution von Iyophilisierten Proteinen |
| EP1958618A1 (de) * | 2007-02-15 | 2008-08-20 | Octapharma AG | Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren |
| WO2011017070A1 (en) | 2009-07-28 | 2011-02-10 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
-
2011
- 2011-12-23 GB GBGB1122430.0A patent/GB201122430D0/en not_active Ceased
-
2012
- 2012-12-24 IN IN1381MUN2014 patent/IN2014MN01381A/en unknown
- 2012-12-24 BR BR112014015605A patent/BR112014015605A2/pt not_active IP Right Cessation
- 2012-12-24 EP EP12813947.4A patent/EP2793852A1/en not_active Withdrawn
- 2012-12-24 JP JP2014548210A patent/JP2015511129A/ja active Pending
- 2012-12-24 WO PCT/GB2012/053266 patent/WO2013093525A1/en not_active Ceased
- 2012-12-24 US US14/367,715 patent/US20140308293A1/en not_active Abandoned
- 2012-12-24 CA CA2859287A patent/CA2859287A1/en not_active Abandoned
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04502770A (ja) * | 1989-04-10 | 1992-05-21 | コーブ ラボラトリーズ インコーポレイテッド | 新規な凍結乾燥及び再形成赤血球組成物 |
| JPH07304658A (ja) * | 1994-05-06 | 1995-11-21 | Immuno Ag | 血液凝固疾患の治療のための安定な調製物 |
| JP2008231091A (ja) * | 2006-12-14 | 2008-10-02 | Johnson & Johnson Regenerative Therapeutics Llc | タンパク質安定化調合物 |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2013093525A1 (en) | 2013-06-27 |
| EP2793852A1 (en) | 2014-10-29 |
| IN2014MN01381A (enExample) | 2015-04-17 |
| GB201122430D0 (en) | 2012-02-08 |
| CA2859287A1 (en) | 2013-06-27 |
| BR112014015605A2 (pt) | 2017-07-04 |
| US20140308293A1 (en) | 2014-10-16 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| DK2793863T3 (en) | PROCEDURE FOR THE PREPARATION OF AMORPH PRECIPTATED PROTEIN PARTICLES | |
| JP2018532730A (ja) | 安定な抗pd−1抗体医薬製剤および医薬におけるその適用 | |
| KR102350284B1 (ko) | 초음파 전구체 제조 방법 | |
| MX2014010776A (es) | Formulaciones farmaceuticas de anticuerpos tnf-alfa. | |
| JPH0314814B2 (enExample) | ||
| JPH11504631A (ja) | Dna/脂質複合体の単一バイアル製剤 | |
| WO2009138644A1 (fr) | Dispositif pour la conservation, la preparation extemporanee et l'administration de principe actif | |
| JP2015511129A (ja) | 高濃度乾燥タンパク質製剤のための再構成方法 | |
| EP3688033A1 (en) | Novel formulations which stabilize low dose antibody compositions | |
| UA75023C2 (en) | A process for the preparation of lipid blend and phospholipid suspension containing lipid blend | |
| US8372798B2 (en) | High-concentration protein formulations and method of manufacture | |
| KR20220008277A (ko) | 가스 충전된 미세소포 | |
| Huang et al. | Spray-dried monoclonal antibody suspension for high-concentration and low-viscosity subcutaneous injection | |
| Garidel et al. | Lyophilization of high-concentration protein formulations | |
| WO2011082196A2 (en) | Rapid reconstitution for lyophilized-pharmaceutical suspensions | |
| EP2895193A1 (fr) | Seringue contenant une composition, notamment pharmaceutique, comprenant des immunoglobulines, son procede de fabrication et son utilisation | |
| JP6869255B2 (ja) | 凍結医薬製剤およびその使用 | |
| CA3162569A1 (en) | Stable antibody formulation | |
| CN101579335B (zh) | 药剂的制剂及其制备和应用方法 | |
| US20160158716A1 (en) | Novel reconstitution assembly | |
| Zhang | Process optimization of albumin-stabilized mitotane nanoparticle preparation by dual centrifugation and first lyophilization study | |
| EP4178983A1 (en) | Stabilized formulations containing anti-ctla-4 antibodies | |
| TW202135860A (zh) | 含有抗cd20x抗cd3雙特異性抗體之穩定調配物 | |
| US20220332849A1 (en) | Stabilized Formulations Containing Anti-MUC16 x Anti-CD3 Bispecific Antibodies | |
| CN109125251A (zh) | 一种包载蛋白类药物的温敏性液晶凝胶制剂及其制备方法 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20151221 |
|
| A977 | Report on retrieval |
Free format text: JAPANESE INTERMEDIATE CODE: A971007 Effective date: 20160930 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20161004 |
|
| A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20170509 |