JP5785077B2 - 崩壊温度より高温での凍結乾燥 - Google Patents

崩壊温度より高温での凍結乾燥 Download PDF

Info

Publication number
JP5785077B2
JP5785077B2 JP2011522218A JP2011522218A JP5785077B2 JP 5785077 B2 JP5785077 B2 JP 5785077B2 JP 2011522218 A JP2011522218 A JP 2011522218A JP 2011522218 A JP2011522218 A JP 2011522218A JP 5785077 B2 JP5785077 B2 JP 5785077B2
Authority
JP
Japan
Prior art keywords
temperature
freeze
collapse
less
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
JP2011522218A
Other languages
English (en)
Japanese (ja)
Other versions
JP2011530524A5 (enExample
JP2011530524A (ja
Inventor
チェサロヴ セルゲイ
チェサロヴ セルゲイ
デクソン ダン
デクソン ダン
ワーン ニコラス
ワーン ニコラス
Original Assignee
ワイス・エルエルシー
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=JP5785077(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ワイス・エルエルシー filed Critical ワイス・エルエルシー
Publication of JP2011530524A publication Critical patent/JP2011530524A/ja
Publication of JP2011530524A5 publication Critical patent/JP2011530524A5/ja
Application granted granted Critical
Publication of JP5785077B2 publication Critical patent/JP5785077B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
JP2011522218A 2008-08-05 2009-08-05 崩壊温度より高温での凍結乾燥 Active JP5785077B2 (ja)

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 (3)

Publication Number Publication Date
JP2011530524A JP2011530524A (ja) 2011-12-22
JP2011530524A5 JP2011530524A5 (enExample) 2012-09-13
JP5785077B2 true JP5785077B2 (ja) 2015-09-24

Family

ID=41401614

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011522218A Active JP5785077B2 (ja) 2008-08-05 2009-08-05 崩壊温度より高温での凍結乾燥

Country Status (6)

Country Link
US (1) US9884019B2 (enExample)
EP (2) EP2323629B1 (enExample)
JP (1) JP5785077B2 (enExample)
CA (1) CA2729972C (enExample)
ES (2) ES2755029T3 (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
US7947649B2 (en) * 2008-04-14 2011-05-24 Advanced Technologies And Regenerative Medicine, Llc Liquid buffered GDF-5 formulations
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
WO2014140361A1 (en) 2013-03-15 2014-09-18 Takeda Gmbh Formulation of an antibody and use thereof
TWI745671B (zh) 2013-03-15 2021-11-11 美商百歐維拉提夫治療公司 因子ix多肽調配物
EA038573B1 (ru) * 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения
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
IL318714A (en) 2018-05-10 2025-03-01 Regeneron Pharma Formulations that include high concentrations of VEGF receptor fusion protein
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
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
CA3168873A1 (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
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
HUP0102812A3 (en) 1998-03-03 2002-01-28 Lilly Co Eli Pharmaceutical compositions containing the phospholipase inhibitor sodium {[3-(2-amino-1,2-dioxoethyl)-2-ethyl-1-(phenylmethyl)-1h-indol-4-yl]oxy}acetate and process for pruducing them
DK2130554T3 (da) * 1999-02-22 2012-12-03 Univ Connecticut 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
PL1750760T3 (pl) * 2004-06-02 2018-02-28 Universal Stabilization Technologies, Inc. Konserwacja za pomocą parowania
ES2349472T3 (es) * 2004-08-12 2011-01-03 Schering Corporation Formulación estable de interferón pegilado.
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
CA2726837A1 (en) 2008-06-26 2009-12-30 Wyeth Llc Lyophilization cycle robustness strategy
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse

Also Published As

Publication number Publication date
US9884019B2 (en) 2018-02-06
WO2010017296A1 (en) 2010-02-11
EP2323629A1 (en) 2011-05-25
EP3572073B1 (en) 2023-12-20
EP2323629B1 (en) 2019-10-09
ES2968301T3 (es) 2024-05-08
JP2011530524A (ja) 2011-12-22
US20100041870A1 (en) 2010-02-18
CA2729972C (en) 2018-11-20
CA2729972A1 (en) 2010-02-11
ES2755029T3 (es) 2020-04-21
EP3572073C0 (en) 2023-12-20
EP3572073A1 (en) 2019-11-27

Similar Documents

Publication Publication Date Title
JP5785077B2 (ja) 崩壊温度より高温での凍結乾燥
Pardeshi et al. Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review
CN101855336B (zh) 含艰难梭菌类毒素a和b的药物组合物
ES2434840T3 (es) Formulación de proteína liofilizada isotónica estable
CN110022855B (zh) 室温稳定的冻干蛋白质
JP2013100329A (ja) 薬学的製剤
KR20120027031A (ko) 소형 모듈 면역제약용 동결건조 제제
JP7264986B2 (ja) 抗Her2抗体薬物コンジュゲートの製剤
US11713922B2 (en) Target residual moisture content for lyophilized drug product
JP2012121894A (ja) Il−1アンタゴニスト製剤
KR20090007588A (ko) 니코틴-담체 백신 제제
JP2011530524A5 (enExample)
PT1771208E (pt) Utilização de derivados de tioflavina radiorotulados em imagiologia amiloide para avaliar terapias anti-amiloide
KR20210078514A (ko) 항-rsv 항체의 제제 및 그의 사용 방법
KR20210113271A (ko) 콜라게나제 제형 및 이의 제조 방법
AU2004206844A1 (en) Parenteral formulations of a peptide for the treatment of systemic lupus erythematosus
CN116033931A (zh) 组织纤溶酶原激活剂制剂
WO2024172859A1 (en) Peptide formulations
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
HK1230484A1 (en) Pharmaceutical compositions containing clostridium difficile toxoids a and b
CN105592857A (zh) 糖疫苗制剂

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120730

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20120730

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20121122

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20121210

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20131129

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20131209

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140217

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140224

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140407

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140414

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20140507

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20140514

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20140609

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20141125

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20150220

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20150423

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150519

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20150713

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20150723

R150 Certificate of patent or registration of utility model

Ref document number: 5785077

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R157 Certificate of patent or utility model (correction)

Free format text: JAPANESE INTERMEDIATE CODE: R157

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250