CA2729972C - Lyophilization above collapse - Google Patents
Lyophilization above collapse Download PDFInfo
- Publication number
- CA2729972C CA2729972C CA2729972A CA2729972A CA2729972C CA 2729972 C CA2729972 C CA 2729972C CA 2729972 A CA2729972 A CA 2729972A CA 2729972 A CA2729972 A CA 2729972A CA 2729972 C CA2729972 C CA 2729972C
- Authority
- CA
- Canada
- Prior art keywords
- collapse
- temperature
- pharmaceutical substance
- lyophilized
- primary drying
- 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
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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 (2)
| Publication Number | Publication Date |
|---|---|
| CA2729972A1 CA2729972A1 (en) | 2010-02-11 |
| CA2729972C true CA2729972C (en) | 2018-11-20 |
Family
ID=41401614
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2729972A Active CA2729972C (en) | 2008-08-05 | 2009-08-05 | Lyophilization above collapse |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US9884019B2 (https=) |
| EP (2) | EP2323629B1 (https=) |
| JP (1) | JP5785077B2 (https=) |
| CA (1) | CA2729972C (https=) |
| ES (2) | ES2968301T3 (https=) |
| WO (1) | WO2010017296A1 (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2009003389A (es) * | 2006-10-03 | 2009-04-09 | Wyeth Corp | Metodos y aparatos de liofilizacion. |
| 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 |
| CN101801405A (zh) | 2007-08-07 | 2010-08-11 | 先进科技及再生医学有限责任公司 | 包含于酸性水溶液中的gdf-5的蛋白质配方 |
| BRPI0911048A2 (pt) * | 2008-04-14 | 2015-12-29 | Atrm Llc | formulações líquidas tamponadas de gdf-5 |
| ES2968301T3 (es) | 2008-08-05 | 2024-05-08 | Wyeth Llc | Liofilización por encima del colapso |
| CA2903611C (en) | 2013-03-15 | 2023-11-07 | Takeda Gmbh | Formulation of an antibody and use thereof |
| AR095527A1 (es) | 2013-03-15 | 2015-10-21 | Biogen Idec Inc | Formulaciones de polipéptido fc-factor ix |
| EA202092926A3 (ru) * | 2014-03-24 | 2021-10-29 | Биовератив Терапьютикс Инк. | Лиофилизированные составы, содержащие фактор ix |
| 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 |
| US11103552B2 (en) | 2018-05-10 | 2021-08-31 | Regeneron Pharmaceuticals, Inc. | High concentration VEGF receptor fusion protein containing formulations |
| 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 |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| MX2022009558A (es) * | 2020-02-04 | 2022-09-09 | Regeneron Pharma | Contenido de humedad residual objetivo para farmaco liofilizado. |
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 |
| EP0762869A1 (en) * | 1994-06-03 | 1997-03-19 | The Procter & Gamble Company | Fast dissolving dosage forms |
| RU2111426C1 (ru) | 1995-11-03 | 1998-05-20 | Государственный научный центр вирусологии и биотехнологии "Вектор" | Способ лиофильной сушки биопрепарата |
| AU757002B2 (en) | 1998-03-03 | 2003-01-30 | Eli Lilly And Company | Pharmaceutical compositions containing the phospholipase inhibitor sodium ((3-(2-amino-1,2-dioxoethyl)-2-ethyl-1- phenylmethyl)-1H-indol-4-YL)oxy)acetate |
| EP2921180B1 (en) * | 1999-02-22 | 2019-08-14 | 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 |
| ES2644416T3 (es) * | 2004-06-02 | 2017-11-28 | Universal Stabilization Technologies, Inc. | Conservación mediante vaporización |
| DE602005022895D1 (de) * | 2004-08-12 | 2010-09-23 | Schering Corp | Stabile pegylierte interferon-formulierung |
| 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 |
| BRPI0620316A2 (pt) * | 2005-12-21 | 2011-11-08 | Wyeth Corp | formulações de proteìnas com viscosidades reduzida e seus usos |
| WO2009158529A2 (en) | 2008-06-26 | 2009-12-30 | Straher, Michael, P. | Lyophilization cycle robustness strategy |
| ES2968301T3 (es) | 2008-08-05 | 2024-05-08 | Wyeth Llc | Liofilización por encima del colapso |
-
2009
- 2009-08-05 ES ES19181153T patent/ES2968301T3/es active Active
- 2009-08-05 WO PCT/US2009/052852 patent/WO2010017296A1/en not_active Ceased
- 2009-08-05 US US12/536,321 patent/US9884019B2/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 JP JP2011522218A patent/JP5785077B2/ja active Active
- 2009-08-05 EP EP19181153.8A patent/EP3572073B1/en not_active Revoked
- 2009-08-05 CA CA2729972A patent/CA2729972C/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| ES2755029T3 (es) | 2020-04-21 |
| EP2323629B1 (en) | 2019-10-09 |
| ES2968301T3 (es) | 2024-05-08 |
| EP2323629A1 (en) | 2011-05-25 |
| JP2011530524A (ja) | 2011-12-22 |
| EP3572073C0 (en) | 2023-12-20 |
| JP5785077B2 (ja) | 2015-09-24 |
| US9884019B2 (en) | 2018-02-06 |
| US20100041870A1 (en) | 2010-02-18 |
| CA2729972A1 (en) | 2010-02-11 |
| EP3572073A1 (en) | 2019-11-27 |
| EP3572073B1 (en) | 2023-12-20 |
| WO2010017296A1 (en) | 2010-02-11 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2729972C (en) | Lyophilization above collapse | |
| Butreddy et al. | Lyophilization of small-molecule injectables: an industry perspective on formulation development, process optimization, scale-up challenges, and drug product quality attributes | |
| Ayensu et al. | Development and physico-mechanical characterisation of lyophilised chitosan wafers as potential protein drug delivery systems via the buccal mucosa | |
| US20200046834A1 (en) | Room temperature stable lyophilized protein | |
| EP2198007B1 (en) | Pharmaceutical compositions containing clostridium difficile toxoids a and b | |
| EP2373293B2 (en) | Compositions with reduced dimer formation | |
| EP2458990B1 (en) | Methods for producing high concentration lyophilized pharmaceutical formulations | |
| JP7710485B2 (ja) | 抗Her2抗体薬物コンジュゲートの製剤 | |
| JP2012121894A (ja) | Il−1アンタゴニスト製剤 | |
| US12066246B2 (en) | Target residual moisture content for lyophilized drug product | |
| CA2764180A1 (en) | Lyophilized formulations for small modular immunopharmaceuticals | |
| WO2005025499A2 (en) | Hydrophobic drug compositions containing reconstitution enhancer | |
| ES2775698T3 (es) | Procedimiento de producción de gránulos liofilizados que comprenden el factor VIII | |
| AU2022335015B2 (en) | LYOPHILISED FORMULATIONS OF mRNA ADSORBED ONTO LIPID NANO-EMULSION PARTICLES | |
| JP2011530524A5 (https=) | ||
| Hawe et al. | Physico-chemical lyophilization behavior of mannitol, human serum albumin formulations | |
| CN102223788A (zh) | 保存混合物及其用途 | |
| CN108379561B (zh) | 一种聚乙二醇化尿酸氧化酶冻干粉剂及其制备方法 | |
| ES2427140T3 (es) | Preparación farmacéutica liofilizada galénica, estable, de polipéptidos recombinantes que fijan los carbohidratos | |
| Bosch | Aggressive freeze-drying: a fast and suitable method to stabilize biopharmaceuticals | |
| Straller et al. | Shrinkage of spray-freeze-dried microparticles of pure protein for ballistic injection by manipulation of freeze-drying cycle | |
| WO2006029467A1 (en) | Rapid freeze drying process | |
| CA3125007C (en) | Collagenase formulations and methods of producing the same | |
| CN101306195A (zh) | 重组人可溶性肿瘤坏死因子相关凋亡诱导配体冻干保护剂及其制备方法 | |
| CN113699120A (zh) | 耐热保护剂及其应用以及可室温保存的活病毒的保存方法 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MPN | Maintenance fee for patent paid |
Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 16TH ANNIV.) - STANDARD Year of fee payment: 16 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20250709 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20250709 |