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

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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)
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 (enExample)
EP (2) EP2323629B1 (enExample)
JP (1) JP5785077B2 (enExample)
CA (1) CA2729972C (enExample)
ES (2) ES2968301T3 (enExample)
WO (1) WO2010017296A1 (enExample)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20090061033A (ko) * 2006-10-03 2009-06-15 와이어쓰 동결건조 방법 및 장치
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
JP5599778B2 (ja) * 2008-04-14 2014-10-01 デピュイ・シンセス・プロダクツ・エルエルシー 液体緩衝ｇｄｆ−５製剤
JP5785077B2 (ja) 2008-08-05 2015-09-24 ワイス・エルエルシー 崩壊温度より高温での凍結乾燥
SG11201505926VA (en) 2013-03-15 2015-09-29 Biogen Ma Inc Factor ix polypeptide formulations
US11576863B2 (en) 2013-03-15 2023-02-14 Takeda Pharmaceutical Company Limited Formulation of an antibody and use thereof
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
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
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
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
WO2021158759A2 (en) 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product

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
CA2191562A1 (en) * 1994-06-03 1995-12-14 Michelle Elizabeth Brideau 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
EP1820516B1 (en) * 1999-02-22 2013-07-24 University of Connecticut Novel 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
AU2005249530B2 (en) * 2004-06-02 2012-04-12 Victor Bronshtein Preservation by vaporization
EP1796647B1 (en) * 2004-08-12 2010-08-11 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
JP5405122B2 (ja) * 2005-12-21 2014-02-05 ワイス・エルエルシー 低粘度のタンパク質製剤およびその用途
WO2009158529A2 (en) 2008-06-26 2009-12-30 Straher, Michael, P. Lyophilization cycle robustness strategy
JP5785077B2 (ja) 2008-08-05 2015-09-24 ワイス・エルエルシー 崩壊温度より高温での凍結乾燥

Also Published As

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

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