JP7049373B2 - 製品を真空凍結乾燥するためのプロセス - Google Patents

製品を真空凍結乾燥するためのプロセス Download PDF

Info

Publication number
JP7049373B2
JP7049373B2 JP2019571529A JP2019571529A JP7049373B2 JP 7049373 B2 JP7049373 B2 JP 7049373B2 JP 2019571529 A JP2019571529 A JP 2019571529A JP 2019571529 A JP2019571529 A JP 2019571529A JP 7049373 B2 JP7049373 B2 JP 7049373B2
Authority
JP
Japan
Prior art keywords
bag
vacuum freeze
product
drying
filling port
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.)
Expired - Fee Related
Application number
JP2019571529A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020527688A5 (https=
JP2020527688A (ja
Inventor
クリストフ カライト
ソフィ デクロメスニル
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.)
4D Pharma Leon SL
Original Assignee
4D Pharma Leon SL
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
Application filed by 4D Pharma Leon SL filed Critical 4D Pharma Leon SL
Publication of JP2020527688A publication Critical patent/JP2020527688A/ja
Publication of JP2020527688A5 publication Critical patent/JP2020527688A5/ja
Priority to JP2022049229A priority Critical patent/JP2022088502A/ja
Application granted granted Critical
Publication of JP7049373B2 publication Critical patent/JP7049373B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D33/00—Details of, or accessories for, sacks or bags
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/001—Handling, e.g. loading or unloading arrangements
    • F26B25/002—Handling, e.g. loading or unloading arrangements for bulk goods
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/06—Chambers, containers, or receptacles
    • F26B25/063—Movable containers or receptacles, e.g. carts, trolleys, pallet-boxes
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/06—Chambers, containers, or receptacles
    • F26B25/14—Chambers, containers, receptacles of simple construction
    • F26B25/16—Chambers, containers, receptacles of simple construction mainly closed, e.g. drum
    • 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
    • F26B5/044—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 for drying materials in a batch operation in an enclosure having a plurality of shelves which may be heated
    • 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
    • F26B5/08—Drying solid materials or objects by processes not involving the application of heat by centrifugal treatment
    • F26B5/10—Drying solid materials or objects by processes not involving the application of heat by centrifugal treatment the process involving freezing

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Packages (AREA)
  • Drying Of Solid Materials (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2019571529A 2017-07-14 2018-07-16 製品を真空凍結乾燥するためのプロセス Expired - Fee Related JP7049373B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022049229A JP2022088502A (ja) 2017-07-14 2022-03-25 製品を真空凍結乾燥するためのプロセス

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1711359.8A GB2564481B (en) 2017-07-14 2017-07-14 Process
GB1711359.8 2017-07-14
PCT/IB2018/055246 WO2019012512A1 (en) 2017-07-14 2018-07-16 PRODUCT LYOPHILIZATION METHOD

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022049229A Division JP2022088502A (ja) 2017-07-14 2022-03-25 製品を真空凍結乾燥するためのプロセス

Publications (3)

Publication Number Publication Date
JP2020527688A JP2020527688A (ja) 2020-09-10
JP2020527688A5 JP2020527688A5 (https=) 2021-08-26
JP7049373B2 true JP7049373B2 (ja) 2022-04-06

Family

ID=59713621

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2019571529A Expired - Fee Related JP7049373B2 (ja) 2017-07-14 2018-07-16 製品を真空凍結乾燥するためのプロセス
JP2022049229A Pending JP2022088502A (ja) 2017-07-14 2022-03-25 製品を真空凍結乾燥するためのプロセス

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2022049229A Pending JP2022088502A (ja) 2017-07-14 2022-03-25 製品を真空凍結乾燥するためのプロセス

Country Status (25)

Country Link
US (2) US11135168B2 (https=)
EP (2) EP3978852A1 (https=)
JP (2) JP7049373B2 (https=)
KR (1) KR20200029497A (https=)
CN (2) CN112762661A (https=)
AU (3) AU2018300358B2 (https=)
CA (1) CA3068394A1 (https=)
CY (1) CY1124780T1 (https=)
DK (1) DK3652491T3 (https=)
ES (1) ES2878136T3 (https=)
GB (1) GB2564481B (https=)
HR (1) HRP20211227T1 (https=)
HU (1) HUE055005T2 (https=)
IL (3) IL271979B (https=)
LT (1) LT3652491T (https=)
MA (1) MA49569B1 (https=)
MD (1) MD3652491T2 (https=)
PL (1) PL3652491T3 (https=)
PT (1) PT3652491T (https=)
RS (1) RS62104B1 (https=)
SG (1) SG11202000223UA (https=)
SI (1) SI3652491T1 (https=)
SM (1) SMT202100446T1 (https=)
TW (1) TWI771451B (https=)
WO (1) WO2019012512A1 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3177359T3 (pl) * 2014-08-04 2020-09-21 F. Hoffmann-La Roche Ag Urządzenie i sposoby do uszczelniania lekarstwa w obrębie medycznego urządzenia dostarczającego
GB2564481B (en) * 2017-07-14 2019-10-23 4D Pharma Leon S L U Process
JP7110360B2 (ja) 2017-10-09 2022-08-01 テルモ ビーシーティー バイオテクノロジーズ，エルエルシー 凍結乾燥方法
CN113614477B (zh) 2019-03-14 2023-04-28 泰尔茂比司特生物技术有限公司 冷冻干燥装载托盘组件及系统
EP3839039A1 (en) 2019-12-16 2021-06-23 4D Pharma Research Limited Providing bacterial biomass with improved storage stability
EP4077633A1 (en) 2019-12-20 2022-10-26 4D Pharma León, S.L.U. Lyophilisation process
TW202304415A (zh) * 2021-04-08 2023-02-01 美商艾弗洛生物科技股份有限公司 含有細菌的藥物製劑
CN113357880B (zh) * 2021-05-17 2022-11-11 云南易门丛山食用菌有限责任公司 一种半冻干松茸的处理工艺
JP2025521429A (ja) * 2022-06-28 2025-07-10 コンプライアンス コンサルティング アンド エンジニアリング サーヴィシーズ， ソシエダ リミターダ プレートスタックシステムを備えた凍結乾燥機における凍結乾燥プロセスを制御するためのシステムおよび設計空間を生成するための方法
EP4357709A1 (en) 2022-10-19 2024-04-24 EAD Sàrl Lyophilization stopper comprising a membrane
CN117367040A (zh) 2023-11-03 2024-01-09 甘肃省药品检验研究院 一种中药材冷冻干燥的加工装置
WO2025099273A1 (en) 2023-11-08 2025-05-15 Bachem Holding Ag Drying bag and drying system
EP4553432B1 (en) 2023-11-08 2026-04-29 Bachem Holding AG Drying bag and drying system

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014043280A (ja) 2013-11-20 2014-03-13 Sumitomo Bakelite Co Ltd 凍結真空乾燥用包装袋及び凍結真空乾燥用包装袋を用いた凍結真空乾燥方法

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1053936A (en) 1911-10-31 1913-02-18 Burt R Van Valkenburg Control-valve.
FR2284842A1 (fr) * 1974-09-11 1976-04-09 Nestle Sa Perfectionnement apporte la lyophilisation des produits solides, liquides ou pateux
US4022206A (en) * 1975-08-01 1977-05-10 Merck & Co., Inc. Vaccine delivery system
US4132848A (en) * 1977-11-03 1979-01-02 Eli Lilly And Company Method of preparing a rapidly dissolving powder of crystalline cephalothin sodium for parenteral administration
CA1232549A (en) * 1983-04-21 1988-02-09 Annie Bedout Container in the form of a flexible bag for liquids to be lyophilized and a method of utilization of said container
US4973327A (en) * 1989-11-01 1990-11-27 Cryopharm Blood bag for lyophilization
KR930001382B1 (ko) * 1990-09-05 1993-02-27 보령신약 주식회사 경구용 장티프스 생균백신 및 그의 제조방법
US5257983A (en) * 1991-04-12 1993-11-02 Cryopharm Corporation Blood bag for lyophilization
JP3121632B2 (ja) * 1991-04-30 2001-01-09 株式会社アズウェル 凍結乾燥製剤の製造方法及び凍結真空乾燥装置
WO1995022036A1 (en) * 1994-02-09 1995-08-17 Kinerton Limited Process for drying a material from solution
ATE208333T1 (de) * 1994-08-05 2001-11-15 West Pharm Serv Cornall Ltd Behälter für feuchtickeitsempfindliche stoffe und entsprechendes verfahren zum trocknen und zur reduktion
WO1996022496A1 (en) * 1995-01-20 1996-07-25 Freezedry Specialties, Inc. Freeze dryer
WO1996031748A1 (en) * 1995-04-07 1996-10-10 W.L. Gore & Associates, Inc. A freeze-drying bag and method for minimizing contamination of freeze-dried products
ZA97452B (en) * 1996-01-25 1997-08-15 Trinity College Dublin Streptococcus equi vaccine.
JPH10305083A (ja) * 1997-05-06 1998-11-17 Nissho Corp 薬剤溶液の凍結乾燥方法
JPH11128315A (ja) * 1997-11-04 1999-05-18 Material Eng Tech Lab Inc 医療用容器
CA2336198A1 (en) * 1998-06-17 1999-12-23 H. Randall Craig Cryogenic freezing of liquids
FR2793767B1 (fr) * 1999-05-17 2001-09-21 Aerospatiale Airbus Dispositif d'accrochage d'un moteur d'aeronef
JP2001106242A (ja) * 1999-10-06 2001-04-17 Shionogi & Co Ltd 凍結乾燥容器、及びそれを用いた凍結乾燥方法
TWI252297B (en) * 2001-12-27 2006-04-01 Jeng-Ming Jou Multi-functional closed type cleaning and vacuum drying method
EP1541158B1 (de) * 2003-12-04 2008-03-05 Cognis IP Management GmbH Antioxidantzubereitung für die orale und/oder topische Anwendung
ES2644416T3 (es) * 2004-06-02 2017-11-28 Universal Stabilization Technologies, Inc. Conservación mediante vaporización
JP4427643B2 (ja) * 2004-08-27 2010-03-10 国立大学法人室蘭工業大学 活性化アルミニウム微粒子の乾燥及び保存方法
DE102005054577A1 (de) * 2005-11-16 2007-05-24 Cognis Ip Management Gmbh Verwendung von Estern ungesättigter, physiologisch aktiver Fettsäuren als Nährmedien für Zellkulturen
US8793895B2 (en) * 2006-02-10 2014-08-05 Praxair Technology, Inc. Lyophilization system and method
US7966746B2 (en) * 2006-04-24 2011-06-28 Medical Instill Technologies, LLC Needle penetrable and laser resealable lyophilization method
EP1958618A1 (de) * 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
US8449520B2 (en) * 2007-03-19 2013-05-28 HemCon Medical Technologies Inc. Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
EP2202472A1 (en) * 2008-12-29 2010-06-30 Ludwig-Maximilians-Universität München Freeze dryer monitoring device
KR101053936B1 (ko) * 2009-09-14 2011-08-04 이희영 생체 이식용 미세 고분자 가공방법
US8549768B2 (en) * 2011-03-11 2013-10-08 Linde Aktiengesellschaft Methods for freeze drying
CN104081142B (zh) * 2011-03-28 2017-03-01 普莱克斯技术有限公司 生物制药的散装冻结
CN202153093U (zh) * 2011-06-12 2012-02-29 陈长清 一种真空冷冻干燥机搁板上使用的托盘
CN103211871A (zh) * 2012-01-24 2013-07-24 贺文军 肉苁蓉的冷冻干燥保鲜加工工艺
CN103169741A (zh) * 2013-01-10 2013-06-26 济南康众医药科技开发有限公司 冻干马齿苋在制备抗疲劳药物中的应用
CA2902155C (en) * 2013-02-22 2023-05-23 Lifenet Health Packaging assembly for storing tissue and cellular material
CN106461327B (zh) * 2014-06-09 2019-12-13 泰尔茂比司特公司 冻干法
WO2016014960A1 (en) * 2014-07-24 2016-01-28 Heat Technologies, Inc. Acoustic-assisted heat and mass transfer device
PL3177359T3 (pl) * 2014-08-04 2020-09-21 F. Hoffmann-La Roche Ag Urządzenie i sposoby do uszczelniania lekarstwa w obrębie medycznego urządzenia dostarczającego
LU92648B1 (en) * 2015-02-04 2016-08-05 Project Pharmaceutics Gmbh Method and device for optimized freeze-drying of a pharmaceutical product
AU2016287585B2 (en) * 2015-07-02 2020-12-17 Otsuka Pharmaceutical Co., Ltd. Lyophilized pharmaceutical compositions
GB2564481B (en) * 2017-07-14 2019-10-23 4D Pharma Leon S L U Process
DE102018007884A1 (de) * 2018-10-05 2020-04-09 Heinz Plöchinger Sensor zur komparativen Druckmessung

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014043280A (ja) 2013-11-20 2014-03-13 Sumitomo Bakelite Co Ltd 凍結真空乾燥用包装袋及び凍結真空乾燥用包装袋を用いた凍結真空乾燥方法

Also Published As

Publication number Publication date
TWI771451B (zh) 2022-07-21
PT3652491T (pt) 2021-07-15
US20200179289A1 (en) 2020-06-11
JP2022088502A (ja) 2022-06-14
AU2018300358B2 (en) 2020-12-24
US20220031621A1 (en) 2022-02-03
IL283604B (en) 2022-02-01
CN110892220B (zh) 2021-02-23
MD3652491T2 (ro) 2021-09-30
CN110892220A (zh) 2020-03-17
HUE055005T2 (hu) 2021-10-28
EP3978852A1 (en) 2022-04-06
CA3068394A1 (en) 2019-01-17
DK3652491T3 (da) 2021-07-05
LT3652491T (lt) 2021-08-10
SMT202100446T1 (it) 2021-09-14
MA49569B1 (fr) 2021-07-29
GB2564481B (en) 2019-10-23
EP3652491B1 (en) 2021-05-12
US11135168B2 (en) 2021-10-05
ES2878136T3 (es) 2021-11-18
JP2020527688A (ja) 2020-09-10
AU2023203930A1 (en) 2023-07-13
IL283604A (en) 2021-07-29
KR20200029497A (ko) 2020-03-18
IL289558A (en) 2022-03-01
CN112762661A (zh) 2021-05-07
US11648204B2 (en) 2023-05-16
TW201934945A (zh) 2019-09-01
SI3652491T1 (sl) 2021-09-30
EP3652491A1 (en) 2020-05-20
SG11202000223UA (en) 2020-02-27
IL271979B (en) 2021-06-30
RS62104B1 (sr) 2021-08-31
PL3652491T3 (pl) 2021-11-08
GB2564481A (en) 2019-01-16
AU2018300358A1 (en) 2020-01-30
AU2021201767A1 (en) 2021-04-15
WO2019012512A1 (en) 2019-01-17
IL271979A (en) 2020-02-27
CY1124780T1 (el) 2022-11-25
HRP20211227T1 (hr) 2021-11-12
GB201711359D0 (en) 2017-08-30

Similar Documents

Publication Publication Date Title
JP7049373B2 (ja) 製品を真空凍結乾燥するためのプロセス
US20110094189A1 (en) Method for filling dual-chamber systems in pre-sterilizable carrier systems and pre-sterilizable carrier system
WO2019217183A1 (en) Lyophilization bag
CN107074428A (zh) 弹性体部件的包装方法和装置
BR112016026149B1 (pt) dispositivo de acondicionamento a granel estéril e processo de fabricação e de acondicionamento a granel estéril
WO2006013360A1 (en) Freeze-drying apparatus
DK2699491T3 (en) Improved flat packaging of petri dishes for long-term preservation and process for making the same.
CN112789472B (zh) 冻干容器
HK40067399A (en) Process for lyophilising a product
HK40028217B (en) Process for lyophilising a product
HK40028217A (en) Process for lyophilising a product
CN112810954A (zh) 一种运用在冻干工艺的一次性无菌容器
JPH11178893A (ja) 薬剤の凍結乾燥方法
WO2015162273A1 (en) A method to dry multiple individual frozen bodies and a system for applying this method
WO2013107173A1 (zh) 制造在相连的盛药皿包装内的冷冻干燥片剂的方法
JPS6334480A (ja) 凍結乾燥方法及びその装置
JPH11139476A (ja) アンプル等の収納容器及びその使用方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200316

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210715

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210715

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20210715

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20210921

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20211221

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: 20220228

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20220325

R150 Certificate of patent or registration of utility model

Ref document number: 7049373

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees