CA2729972C - Lyophilization above collapse - Google Patents

Lyophilization above collapse Download PDF

Info

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) ES2968301T3 (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
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)

* 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
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

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