DK1982132T3 - Fremgangsmåde til lyofilisering - Google Patents
Fremgangsmåde til lyofilisering Download PDFInfo
- Publication number
- DK1982132T3 DK1982132T3 DK07750149.2T DK07750149T DK1982132T3 DK 1982132 T3 DK1982132 T3 DK 1982132T3 DK 07750149 T DK07750149 T DK 07750149T DK 1982132 T3 DK1982132 T3 DK 1982132T3
- Authority
- DK
- Denmark
- Prior art keywords
- nucleation
- freeze
- temperature
- pressure
- vials
- Prior art date
Links
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Immunology (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Virology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Drying Of Solid Materials (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (6)
1. Fremgangsmåde til lyofilisering af et materiale, der omfatter trinene: påføring af overtryk af gasatmosfæren i et kammer (202) til et tryk på mellem omgivende tryk og 172,4 kPa (25 psi) over omgivende tryk og nedkøling af materialet i trykkammeret ved en foreskreven nedkølingshastighed til en ønsket kernedanneIsestemperatur; hurtig sænkning af trykket i kammeret (202) i løbet af 40 sekunder eller mindre ved en trykfaldshastighed, AP/At, på over 1,4 kPa (0,2 psi) pr. sekund til inducering af kernedannelse ved frysning i materialet ved den ønskede kernedannelsestemperatur ; yderligere nedkøling af det kernedannede materiale til eller under en sluttemperatur til frysning af materialet; og tørring af det frosne materiale til frembringelse af et tørret produkt med reduceret fugt eller opløsningsmiddel.
2. Fremgangsmåde til lyofilisering ifølge krav 1, hvor materialet indledningsvis nedkøles til en temperatur i intervallet fra faseovergangstemperaturen til 20 °C under faseovergangstemperaturen før trykreduktion.
3. Fremgangsmåde til lyofilisering ifølge et hvilket som helst af ovennævnte krav, hvor trykket reduceres med ca. 48,3 kPa (7 psi) eller mere.
4. Fremgangsmåde til lyofilisering ifølge et hvilket som helst af ovennævnte krav, hvor trykket reduceres, således at et absolut trykforhold, Pi/Pf, er ca. 1,2 eller mere.
5. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor materialet yderligere omfatter en eller flere bestanddele, der omfatter et levende eller svækket virus; en nukleinsyre; et monoklonalt antistof; et polyklonalt antistof; et protein; et peptid; eller et polypeptid.
6. Fremgangsmåde ifølge krav 5, hvor bestanddele af rekonstitueret materiale fremviser en funktion eller aktivitet, der er forbedret i forhold til funktionen eller aktiviteten, der er forbundet med bestanddele af rekonstitueret materiale fra et stokastisk kernedannet materiale.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US77186806P | 2006-02-10 | 2006-02-10 | |
US11/702,479 US8793895B2 (en) | 2006-02-10 | 2007-02-05 | Lyophilization system and method |
PCT/US2007/003281 WO2007095033A2 (en) | 2006-02-10 | 2007-02-07 | Lyophilization system and method |
Publications (1)
Publication Number | Publication Date |
---|---|
DK1982132T3 true DK1982132T3 (da) | 2016-12-05 |
Family
ID=38366837
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK16176394.1T DK3136030T3 (da) | 2006-02-10 | 2007-02-07 | Fremgangsmåde til lyofilisering |
DK07750149.2T DK1982132T3 (da) | 2006-02-10 | 2007-02-07 | Fremgangsmåde til lyofilisering |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK16176394.1T DK3136030T3 (da) | 2006-02-10 | 2007-02-07 | Fremgangsmåde til lyofilisering |
Country Status (15)
Country | Link |
---|---|
US (3) | US8793895B2 (da) |
EP (3) | EP3567328A1 (da) |
JP (1) | JP5090374B2 (da) |
KR (1) | KR101265381B1 (da) |
AU (1) | AU2007215418B2 (da) |
BR (2) | BRPI0706768B1 (da) |
CA (1) | CA2640590C (da) |
DK (2) | DK3136030T3 (da) |
ES (2) | ES2602501T3 (da) |
HU (2) | HUE047058T2 (da) |
IL (1) | IL192544A (da) |
NO (1) | NO20083548L (da) |
PT (2) | PT3136030T (da) |
SI (2) | SI1982132T1 (da) |
WO (1) | WO2007095033A2 (da) |
Families Citing this family (49)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8793895B2 (en) * | 2006-02-10 | 2014-08-05 | Praxair Technology, Inc. | Lyophilization system and method |
EP1870649A1 (en) * | 2006-06-20 | 2007-12-26 | Octapharma AG | Lyophilisation targetting defined residual moisture by limited desorption energy levels |
US8015841B2 (en) * | 2006-09-08 | 2011-09-13 | Praxair Technology, Inc. | Cryogenic refrigeration system for lyophilization |
US8240065B2 (en) * | 2007-02-05 | 2012-08-14 | Praxair Technology, Inc. | Freeze-dryer and method of controlling the same |
US10023857B2 (en) | 2008-09-12 | 2018-07-17 | En Wave Corporation | Apparatus and method for dehydrating biological materials with freezing and microwaving |
US20110179667A1 (en) * | 2009-09-17 | 2011-07-28 | Lee Ron C | Freeze drying system |
US8966782B2 (en) * | 2010-09-28 | 2015-03-03 | Baxter International Inc. | Optimization of nucleation and crystallization for lyophilization using gap freezing |
ES2621017T3 (es) * | 2010-09-28 | 2017-06-30 | Baxter International Inc | Optimización de la nucleación y cristalización en la liofilización utilizando una congelación con intersticios |
US8549768B2 (en) * | 2011-03-11 | 2013-10-08 | Linde Aktiengesellschaft | Methods for freeze drying |
EP2691719A4 (en) * | 2011-03-28 | 2015-05-27 | Praxair Technology Inc | BULK CLEARANCE OF BIOPHARMACEUTICAL PRODUCTS |
US8839528B2 (en) * | 2011-04-29 | 2014-09-23 | Millrock Technology, Inc. | Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice fog distribution |
JP2013055230A (ja) * | 2011-09-05 | 2013-03-21 | Toshiba Corp | 半導体基板の超臨界乾燥方法 |
FR2990269B1 (fr) * | 2012-05-02 | 2018-06-29 | L'air Liquide,Societe Anonyme Pour L'etude Et L'exploitation Des Procedes Georges Claude | Procede de lyophilisation |
JP5827178B2 (ja) * | 2012-06-05 | 2015-12-02 | 北越紀州製紙株式会社 | セルロース多孔質体及びその製造方法 |
US8875413B2 (en) * | 2012-08-13 | 2014-11-04 | Millrock Technology, Inc. | Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice crystals distribution from condensed frost |
DE102012021655B4 (de) | 2012-11-03 | 2023-03-30 | Hof Sonderanlagenbau Gmbh | Verfahren zur Gefriertrocknung eines mit einem Lösungsmittel versehenen, feuchten Produktes |
DK2970878T3 (da) | 2013-03-15 | 2018-09-03 | Truckee Applied Genomics Llc | Fremgangsmåder og reagenser til opretholdelse af levedygtigheden af cancerceller i operativt fjernet væv |
CN105452791B (zh) * | 2013-05-29 | 2017-05-31 | 基伊埃工程技术股份有限公司 | 提供内联灭菌冷冻干燥容纳在手推车托盘中产品的方法、用于执行该方法的***和对该方法的使用 |
US9121637B2 (en) * | 2013-06-25 | 2015-09-01 | Millrock Technology Inc. | Using surface heat flux measurement to monitor and control a freeze drying process |
US20160228371A1 (en) * | 2013-10-18 | 2016-08-11 | Abbvie Inc. | Stable solid units and methods of making the same |
US10801070B2 (en) | 2013-11-25 | 2020-10-13 | The Broad Institute, Inc. | Compositions and methods for diagnosing, evaluating and treating cancer |
US11725237B2 (en) | 2013-12-05 | 2023-08-15 | The Broad Institute Inc. | Polymorphic gene typing and somatic change detection using sequencing data |
CA2932798C (en) * | 2013-12-06 | 2022-09-20 | The Broad Institute, Inc. | Formulations for neoplasia vaccines |
CN106456724A (zh) | 2013-12-20 | 2017-02-22 | 博德研究所 | 使用新抗原疫苗的联合疗法 |
CN112979828A (zh) | 2014-07-17 | 2021-06-18 | 恺兴生命科技(上海)有限公司 | 靶向cld18a2的t淋巴细胞及其制备方法和应用 |
US10993997B2 (en) | 2014-12-19 | 2021-05-04 | The Broad Institute, Inc. | Methods for profiling the t cell repertoire |
WO2016100975A1 (en) | 2014-12-19 | 2016-06-23 | Massachsetts Institute Ot Technology | Molecular biomarkers for cancer immunotherapy |
JP5847919B1 (ja) * | 2014-12-26 | 2016-01-27 | 共和真空技術株式会社 | 凍結乾燥装置の凍結乾燥方法 |
KR102427458B1 (ko) | 2015-05-19 | 2022-08-01 | 메디칸(주) | 동결건조 방법 및 장치 |
TWI806815B (zh) | 2015-05-20 | 2023-07-01 | 美商博德研究所有限公司 | 共有之gata3相關之腫瘤特異性新抗原 |
US10605527B2 (en) | 2015-09-22 | 2020-03-31 | Millrock Technology, Inc. | Apparatus and method for developing freeze drying protocols using small batches of product |
JP6665063B2 (ja) * | 2015-11-24 | 2020-03-13 | 株式会社西部技研 | 乾燥装置 |
JP6446604B2 (ja) * | 2016-09-08 | 2018-12-26 | アトナープ株式会社 | 事前分離ユニットを有するシステム |
US10113797B2 (en) | 2016-09-09 | 2018-10-30 | Sp Industries, Inc. | Energy recovery in a freeze-drying system |
BR112019006900A2 (pt) | 2016-10-05 | 2019-07-02 | Zoetis Services Llc | métodos de liofilização que proporcionam protozoários desidratados estáveis para o uso como potentes vacinas vivas |
EP3574116A1 (en) | 2017-01-24 | 2019-12-04 | The Broad Institute, Inc. | Compositions and methods for detecting a mutant variant of a polynucleotide |
EP3655000A4 (en) * | 2017-07-11 | 2021-07-14 | Universal Stabilization Technologies, Inc. | PROCESS FOR THE PRESERVATION OF BIOPHARMACEUTICALS |
GB2564481B (en) * | 2017-07-14 | 2019-10-23 | 4D Pharma Leon S L U | Process |
CN112005069B (zh) * | 2018-04-10 | 2023-01-10 | Ima生命北美股份有限公司 | 冷冻干燥处理和装备健康状况监测 |
WO2020002605A1 (en) * | 2018-06-29 | 2020-01-02 | Universiteit Gent | Freezing, drying and/or freeze-drying of product dose units |
HUE064508T2 (hu) * | 2018-09-26 | 2024-03-28 | Medac Ges Fuer Klinische Spezialpraeparate Mbh | Treoszulfán liofilizát |
US11744257B1 (en) | 2018-10-19 | 2023-09-05 | Harvest Right, LLC | Freeze-drying methods including vacuum freezing |
US10966439B2 (en) * | 2019-01-27 | 2021-04-06 | Vinamit Usa Llc | Concentrated fruit juice powder and method for preparing the same using a non-linear screw press juicer and convection current freeze drying apparatus |
US10676797B1 (en) * | 2019-01-27 | 2020-06-09 | Vinamit Usa Llc | Concentrated sugarcane juice powder and method for preparing the same using the convection current freeze drying apparatus |
US10921058B2 (en) * | 2019-01-27 | 2021-02-16 | Vinamit Usa Llc | Fully automatic convection current vacuum freeze drying method |
JP6667884B1 (ja) * | 2019-07-17 | 2020-03-18 | 株式会社松井製作所 | 粉粒体材料の乾燥装置及び粉粒体材料の乾燥方法 |
CN111346253B (zh) * | 2020-03-10 | 2022-04-08 | 西安培华学院 | 一种水溶性多层生物材料的制备方法 |
US11287185B1 (en) | 2020-09-09 | 2022-03-29 | Stay Fresh Technology, LLC | Freeze drying with constant-pressure and constant-temperature phases |
WO2022175999A1 (ja) * | 2021-02-16 | 2022-08-25 | 株式会社アルバック | 凍結乾燥装置、および凍結乾燥方法 |
Family Cites Families (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4590684A (en) | 1984-11-20 | 1986-05-27 | Eden Research Laboratories, Inc. | Continuous freeze drying |
US4597188A (en) | 1985-03-04 | 1986-07-01 | Trappler Edward H | Freeze dry process and structure |
JPH05277302A (ja) * | 1992-04-02 | 1993-10-26 | Japan Steel Works Ltd:The | 高水分材料の凍結濃縮方法及び装置 |
WO1995022036A1 (en) | 1994-02-09 | 1995-08-17 | Kinerton Limited | Process for drying a material from solution |
US5937656A (en) | 1997-05-07 | 1999-08-17 | Praxair Technology, Inc. | Nonfreezing heat exchanger |
US5966966A (en) | 1997-05-21 | 1999-10-19 | Trustees Of Tufts College | Process and system for freeze concentration using ultrasonic nucleation useful in effluent processing |
JP3050533B2 (ja) * | 1997-06-10 | 2000-06-12 | 京都府 | 殺菌方法および殺菌装置 |
DE19751031A1 (de) | 1997-11-19 | 1999-06-24 | Ingo Dipl Ing Heschel | Verfahren zur Herstellung poröser Strukturen |
US6270723B1 (en) * | 1998-06-15 | 2001-08-07 | Bbi Bioseq, Inc. | Rapid cryobaric sterilization and vaccine preparation |
US6696019B2 (en) * | 1998-06-15 | 2004-02-24 | Bbi Bioseq, Inc. | Rapid cryobaric sterilization and vaccine preparation |
DE19936281C2 (de) | 1999-08-02 | 2002-04-04 | Bayer Ag | Verfahren zur Gefriertrocknung |
US6630185B2 (en) | 2000-07-18 | 2003-10-07 | Lipton, Division Of Conopco, Inc. | Crystallization process using ultrasound |
JP4104391B2 (ja) | 2001-08-10 | 2008-06-18 | カルソニックコンプレッサー株式会社 | 気体圧縮機 |
EP1494651A4 (en) * | 2002-04-11 | 2010-10-13 | Medimmune Vaccines Inc | PRESERVATION OF BIO-ACTIVE MATERIALS WITH LYOPHILIZED FOAM |
JP3869297B2 (ja) * | 2002-04-16 | 2007-01-17 | 共和真空技術株式会社 | 凍結乾燥機における棚段の温度制御装置 |
GB0308360D0 (en) | 2003-04-11 | 2003-05-14 | Acton Elizabeth | Improved method of freeze drying |
JP2005060378A (ja) * | 2003-07-28 | 2005-03-10 | Yamanouchi Pharmaceut Co Ltd | 生理活性蛋白質含有凍結乾燥製剤 |
US7229603B2 (en) | 2004-06-17 | 2007-06-12 | Anazaohealth Corporation | Stablilized and lyophilized radiopharmaceutical agents |
US8793895B2 (en) * | 2006-02-10 | 2014-08-05 | Praxair Technology, Inc. | Lyophilization system and method |
US9453675B2 (en) * | 2006-02-10 | 2016-09-27 | Sp Industries, Inc. | Method of inducing nucleation of a material |
-
2007
- 2007-02-05 US US11/702,479 patent/US8793895B2/en active Active
- 2007-02-07 PT PT161763941T patent/PT3136030T/pt unknown
- 2007-02-07 HU HUE16176394A patent/HUE047058T2/hu unknown
- 2007-02-07 DK DK16176394.1T patent/DK3136030T3/da active
- 2007-02-07 CA CA2640590A patent/CA2640590C/en active Active
- 2007-02-07 ES ES07750149.2T patent/ES2602501T3/es active Active
- 2007-02-07 SI SI200731859A patent/SI1982132T1/sl unknown
- 2007-02-07 EP EP19183156.9A patent/EP3567328A1/en not_active Withdrawn
- 2007-02-07 DK DK07750149.2T patent/DK1982132T3/da active
- 2007-02-07 EP EP07750149.2A patent/EP1982132B1/en active Active
- 2007-02-07 PT PT77501492T patent/PT1982132T/pt unknown
- 2007-02-07 JP JP2008554315A patent/JP5090374B2/ja active Active
- 2007-02-07 SI SI200732131T patent/SI3136030T1/sl unknown
- 2007-02-07 BR BRPI0706768-2A patent/BRPI0706768B1/pt active IP Right Grant
- 2007-02-07 HU HUE07750149A patent/HUE031810T2/en unknown
- 2007-02-07 BR BR122019027321-9A patent/BR122019027321B1/pt active IP Right Grant
- 2007-02-07 ES ES16176394T patent/ES2748911T3/es active Active
- 2007-02-07 WO PCT/US2007/003281 patent/WO2007095033A2/en active Application Filing
- 2007-02-07 AU AU2007215418A patent/AU2007215418B2/en active Active
- 2007-02-07 EP EP16176394.1A patent/EP3136030B1/en active Active
-
2008
- 2008-06-30 IL IL192544A patent/IL192544A/en active IP Right Grant
- 2008-08-08 KR KR1020087019456A patent/KR101265381B1/ko active IP Right Grant
- 2008-08-14 NO NO20083548A patent/NO20083548L/no not_active Application Discontinuation
-
2014
- 2014-07-18 US US14/334,722 patent/US9200836B2/en active Active
-
2015
- 2015-11-17 US US14/943,282 patent/US9651305B2/en active Active
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
DK1982132T3 (da) | Fremgangsmåde til lyofilisering | |
CA2640833C (en) | Method of inducing nucleation of a material | |
US8794013B2 (en) | Method and system for nucleation control in a controlled rate freezer (CRF) | |
US8820097B2 (en) | Method and system for regulating the mixture of cryogen liquid and warm gas for a controlled rate cryogenic chiller or freezing system | |
MX2008009384A (en) | Method of inducing nucleation of a material | |
MX2008009175A (en) | Lyophilization system and method |