CA2729972C - Lyophilization above collapse - Google Patents

Lyophilization above collapse Download PDF

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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
Application number
CA2729972A
Other languages
English (en)
French (fr)
Other versions
CA2729972A1 (en
Inventor
Serguei Tchessalov
Dan Dixon
Nicholas Warne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41401614&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2729972(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Wyeth LLC filed Critical Wyeth LLC
Publication of CA2729972A1 publication Critical patent/CA2729972A1/en
Application granted granted Critical
Publication of CA2729972C publication Critical patent/CA2729972C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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)
CA2729972A 2008-08-05 2009-08-05 Lyophilization above collapse Active CA2729972C (en)

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) ES2755029T3 (https=)
WO (1) WO2010017296A1 (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008042408A2 (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
JP5323832B2 (ja) 2007-08-07 2013-10-23 アドバンスト・テクノロジーズ・アンド・リジェネレイティブ・メディスン・エルエルシー 酸性水溶液中にgdf−5を含むタンパク質製剤
BRPI0911048A2 (pt) * 2008-04-14 2015-12-29 Atrm Llc formulações líquidas tamponadas de gdf-5
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
US11576863B2 (en) 2013-03-15 2023-02-14 Takeda Pharmaceutical Company Limited Formulation of an antibody and use thereof
WO2014144549A1 (en) 2013-03-15 2014-09-18 Biogen Idec Ma Inc. Factor ix polypeptide formulations
AU2015236340B2 (en) 2014-03-24 2020-02-06 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
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
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
BR112022015272A2 (pt) 2020-02-04 2022-09-20 Regeneron Pharma Teor de umidade residual alvo para produto de fármaco liofilizado

Family Cites Families (14)

* Cited by examiner, † Cited by third party
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
DE69928500T2 (de) 1998-03-03 2006-08-03 Eli Lilly And Co., Indianapolis Pharmazeutische zusammensetzung enthaltend den phospholipase inhibitor natrium-[[3-(2-amino-1,2-dioxoethyl)-2-ethyl-1-phenylmethyl)-1 h-indol-4-yl]oxy]acetat
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
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
EP1750760B1 (en) * 2004-06-02 2017-06-28 Universal Stabilization Technologies, Inc. Preservation by vaporization
CA2576549C (en) * 2004-08-12 2011-01-18 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
BRPI0620316A2 (pt) * 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos
JP2011526356A (ja) 2008-06-26 2011-10-06 ワイス・エルエルシー 凍結乾燥サイクルのロバスト性(robustness)方策
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse

Also Published As

Publication number Publication date
EP3572073C0 (en) 2023-12-20
JP2011530524A (ja) 2011-12-22
EP2323629A1 (en) 2011-05-25
EP3572073B1 (en) 2023-12-20
WO2010017296A1 (en) 2010-02-11
ES2968301T3 (es) 2024-05-08
CA2729972A1 (en) 2010-02-11
ES2755029T3 (es) 2020-04-21
EP2323629B1 (en) 2019-10-09
EP3572073A1 (en) 2019-11-27
US20100041870A1 (en) 2010-02-18
JP5785077B2 (ja) 2015-09-24
US9884019B2 (en) 2018-02-06

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