CA2574614C - Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) - Google Patents
Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) Download PDFInfo
- Publication number
- CA2574614C CA2574614C CA2574614A CA2574614A CA2574614C CA 2574614 C CA2574614 C CA 2574614C CA 2574614 A CA2574614 A CA 2574614A CA 2574614 A CA2574614 A CA 2574614A CA 2574614 C CA2574614 C CA 2574614C
- Authority
- CA
- Canada
- Prior art keywords
- freeze
- pellets
- drying
- frozen
- droplets
- 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
Links
- 239000008188 pellet Substances 0.000 title claims abstract description 117
- 238000000034 method Methods 0.000 title claims abstract description 99
- 230000008569 process Effects 0.000 title claims abstract description 95
- 238000004108 freeze drying Methods 0.000 title claims description 38
- 238000007710 freezing Methods 0.000 title claims description 34
- 230000008014 freezing Effects 0.000 title claims description 34
- 238000001035 drying Methods 0.000 title description 40
- 238000005429 filling process Methods 0.000 title description 8
- 229960000074 biopharmaceutical Drugs 0.000 title description 6
- 239000002245 particle Substances 0.000 claims description 32
- 238000009826 distribution Methods 0.000 claims description 22
- 238000001816 cooling Methods 0.000 claims description 13
- 239000004480 active ingredient Substances 0.000 claims description 7
- 238000011068 loading method Methods 0.000 claims description 7
- 239000000047 product Substances 0.000 description 39
- 238000011049 filling Methods 0.000 description 26
- 239000007789 gas Substances 0.000 description 26
- 239000007788 liquid Substances 0.000 description 21
- 239000008187 granular material Substances 0.000 description 20
- 238000004519 manufacturing process Methods 0.000 description 18
- 239000000463 material Substances 0.000 description 16
- 239000000243 solution Substances 0.000 description 16
- 238000003860 storage Methods 0.000 description 15
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 14
- 239000007921 spray Substances 0.000 description 13
- 239000011236 particulate material Substances 0.000 description 12
- 239000000969 carrier Substances 0.000 description 11
- 230000000694 effects Effects 0.000 description 11
- 239000000203 mixture Substances 0.000 description 10
- 238000000859 sublimation Methods 0.000 description 10
- 230000008022 sublimation Effects 0.000 description 10
- 238000012546 transfer Methods 0.000 description 8
- 238000009835 boiling Methods 0.000 description 7
- 239000008364 bulk solution Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 7
- 229910052757 nitrogen Inorganic materials 0.000 description 7
- 239000000843 powder Substances 0.000 description 7
- 238000003556 assay Methods 0.000 description 6
- 230000001419 dependent effect Effects 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 238000010438 heat treatment Methods 0.000 description 6
- 239000007787 solid Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 239000012530 fluid Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 229960005486 vaccine Drugs 0.000 description 5
- 239000012467 final product Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 238000004781 supercooling Methods 0.000 description 4
- 238000005054 agglomeration Methods 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 3
- 238000004166 bioassay Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 238000005453 pelletization Methods 0.000 description 3
- 230000005855 radiation Effects 0.000 description 3
- 238000007669 thermal treatment Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 239000012669 liquid formulation Substances 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000003032 molecular docking Methods 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 238000003892 spreading Methods 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- 230000032258 transport Effects 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 238000000137 annealing Methods 0.000 description 1
- 239000008346 aqueous phase Substances 0.000 description 1
- 230000002902 bimodal effect Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000009529 body temperature measurement Methods 0.000 description 1
- 239000013590 bulk material Substances 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- 239000002826 coolant Substances 0.000 description 1
- 239000000112 cooling gas Substances 0.000 description 1
- 239000000110 cooling liquid Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000003844 drug implant Substances 0.000 description 1
- 230000005684 electric field Effects 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 238000005243 fluidization Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000012263 liquid product Substances 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 229940095674 pellet product Drugs 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 238000004544 sputter deposition Methods 0.000 description 1
- 238000012859 sterile filling Methods 0.000 description 1
- 238000012027 sterile manufacturing Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- -1 vaccines Chemical class 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
Classifications
-
- 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
- F26B5/065—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 the product to be freeze-dried being sprayed, dispersed or pulverised
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Drying Of Solid Materials (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US59088104P | 2004-07-23 | 2004-07-23 | |
| US60/590,881 | 2004-07-23 | ||
| PCT/EP2005/007455 WO2006008006A1 (en) | 2004-07-23 | 2005-07-09 | Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2574614A1 CA2574614A1 (en) | 2006-01-26 |
| CA2574614C true CA2574614C (en) | 2013-12-03 |
Family
ID=35426977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2574614A Expired - Fee Related CA2574614C (en) | 2004-07-23 | 2005-07-09 | Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals) |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US7836606B2 (https=) |
| EP (1) | EP1794524B1 (https=) |
| JP (1) | JP4829229B2 (https=) |
| AT (1) | ATE542095T1 (https=) |
| AU (1) | AU2005263465B2 (https=) |
| CA (1) | CA2574614C (https=) |
| DK (1) | DK1794524T3 (https=) |
| IL (1) | IL180898A (https=) |
| WO (1) | WO2006008006A1 (https=) |
Families Citing this family (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5183068B2 (ja) * | 2003-12-22 | 2013-04-17 | フィンレイ，ウォーレン，エイチ | 大気噴出凍結乾燥法による粉末形成 |
| DE102004007526A1 (de) * | 2004-02-17 | 2005-09-01 | Oetjen, Georg-Wilhelm, Dr. | Verfahren und Einrichtung zur Gefriertrocknung von Produkten |
| DE102005053695B4 (de) * | 2005-11-10 | 2008-04-30 | Airbus Deutschland Gmbh | Verfahren zum Handhaben einer Flüssigkeit |
| JP5173159B2 (ja) * | 2006-07-14 | 2013-03-27 | 株式会社モリモト医薬 | 凍結乾燥方法および凍結乾燥装置 |
| MX2009003389A (es) * | 2006-10-03 | 2009-04-09 | Wyeth Corp | Metodos y aparatos de liofilizacion. |
| EP2107934B1 (en) * | 2006-12-07 | 2019-11-20 | FrieslandCampina Nederland B.V. | Method and apparatus for spray drying |
| US7908765B2 (en) * | 2006-12-22 | 2011-03-22 | Collette Nv | Continuous granulating and drying apparatus |
| TWI436789B (zh) | 2008-01-21 | 2014-05-11 | Intervet Int Bv | 含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包 |
| TWI444384B (zh) * | 2008-02-20 | 2014-07-11 | Gilead Sciences Inc | 核苷酸類似物及其在治療惡性腫瘤上的用途 |
| ES2615390T3 (es) | 2008-03-05 | 2017-06-06 | Sanofi Pasteur | Proceso para estabilizar una composición de vacuna que contiene adyuvante |
| EP2143440A1 (fr) | 2008-07-09 | 2010-01-13 | Sanofi Pasteur | Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués |
| TW201043267A (en) | 2009-03-19 | 2010-12-16 | Intervet Int Bv | In situ constituting a vaccine for administration to a predetermined herd of animals |
| WO2010117976A1 (en) | 2009-04-09 | 2010-10-14 | Entegrion, Inc | Spray-dried blood products and methods of making same |
| US20110142885A1 (en) | 2009-09-16 | 2011-06-16 | Velico Medical, Inc. | Spray-dried human plasma |
| US8407912B2 (en) | 2010-09-16 | 2013-04-02 | Velico Medical, Inc. | Spray dried human plasma |
| EP2496253B1 (en) | 2009-11-02 | 2019-01-09 | MannKind Corporation | Apparatus and method for cryogranulating a pharmaceutical composition |
| US9945611B2 (en) | 2010-08-04 | 2018-04-17 | Ima Life North America Inc. | Bulk freeze drying using spray freezing and agitated drying |
| ES2649045T3 (es) * | 2010-08-04 | 2018-01-09 | Ima Life North America Inc. | Liofilización a granel mediante congelación por pulverización y secado agitado |
| EP2632580A2 (en) | 2010-10-29 | 2013-09-04 | Velico Medical, Inc. | System and method for spray drying a liquid |
| US20140083628A1 (en) | 2012-09-27 | 2014-03-27 | Velico Medical, Inc. | Spray drier assembly for automated spray drying |
| EP2578974A1 (en) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Process line for the production of freeze-dried particles |
| EP2578975A1 (en) | 2011-10-05 | 2013-04-10 | Sanofi Pasteur Sa | Rotary drum freeze-dryer |
| JP2014533240A (ja) | 2011-10-31 | 2014-12-11 | メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． | 生物材料の凍結乾燥球形ペレットを調製する方法 |
| DE102012109406B4 (de) * | 2012-10-02 | 2016-04-28 | Richard Süverkrüp | Verfahren und Anlage zur kontinuierlichen Produktion von pharmazeutischen Lyophilisaten |
| AU2013202805B2 (en) | 2013-03-14 | 2015-07-16 | Gen-Probe Incorporated | System and method for extending the capabilities of a diagnostic analyzer |
| CN107073350B (zh) * | 2014-07-21 | 2019-11-15 | 赛诺菲巴斯德股份公司 | 用于产生液滴的液体给送装置 |
| US9561184B2 (en) | 2014-09-19 | 2017-02-07 | Velico Medical, Inc. | Methods and systems for multi-stage drying of plasma |
| JP5837670B2 (ja) * | 2014-10-24 | 2015-12-24 | アイエムエー ライフ ノース アメリカ インコーポレーテッド | 噴霧凍結および撹拌乾燥を使用するバルク・フリーズドライ |
| RU2578010C1 (ru) * | 2014-11-13 | 2016-03-20 | Федеральное государственное бюджетное научное учреждение "Всероссийский научно-исследовательский институт механизации животноводства" (ФГБНУ ВНИИМЖ) | Вакуум-сублимационная сушилка |
| ES2760075T3 (es) | 2015-06-01 | 2020-05-13 | Ima Life North America Inc | Liofilización a granel utilizando congelación por pulverización y secado en agitación con calentamiento |
| US10605527B2 (en) * | 2015-09-22 | 2020-03-31 | Millrock Technology, Inc. | Apparatus and method for developing freeze drying protocols using small batches of product |
| EP3167877A1 (en) | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Method for the production of freeze-dried pellets comprising factor viii |
| WO2018186343A1 (ja) * | 2017-04-04 | 2018-10-11 | 日東電工株式会社 | 凍結乾燥体の製造方法及びその製造装置 |
| WO2019192747A1 (de) * | 2018-04-05 | 2019-10-10 | Paechnatz Torsten | Gefriertrocknungsanlage und verfahren hierzu |
| WO2020008022A1 (en) * | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY |
| DK3944867T3 (da) * | 2020-07-31 | 2023-04-11 | Cup Laboratorien Dr Freitag Gmbh | Anlæg og fremgangsmåde til sterilitetskontrol af radioaktive stoffer |
| US11874060B2 (en) * | 2020-11-16 | 2024-01-16 | Sublime Stericeuticals Corporation | Continuous throughput lyophilizer-powder filler within a sterile boundary |
| DE202021101537U1 (de) * | 2021-03-24 | 2021-05-18 | Torsten Pächnatz | Gefriertrocknungsanlage |
| EP4422704A1 (en) * | 2021-10-28 | 2024-09-04 | Comecer S.p.A. | System and method for rapid and sterile transfer of a vial into an isolator |
| IT202100027668A1 (it) * | 2021-10-28 | 2023-04-28 | Comecer Spa | Metodo per trasferire in modo rapido e sterile una fiala in un isolatore |
| US12246093B2 (en) | 2022-09-15 | 2025-03-11 | Velico Medical, Inc. | Methods for making spray dried plasma |
| US12083447B2 (en) | 2022-09-15 | 2024-09-10 | Velico Medical, Inc. | Alignment of a disposable for a spray drying plasma system |
| US11998861B2 (en) | 2022-09-15 | 2024-06-04 | Velico Medical, Inc. | Usability of a disposable for a spray drying plasma system |
| WO2024059770A1 (en) | 2022-09-15 | 2024-03-21 | Velico Medical, Inc. | Rapid spray drying system |
| US12571587B2 (en) | 2022-09-15 | 2026-03-10 | Velico Medical, Inc. | Finishing apparatus for a spray drying system |
| US12539355B2 (en) | 2022-09-15 | 2026-02-03 | Velico Medical, Inc. | Dryer for a spray drying system |
| US11975274B2 (en) | 2022-09-15 | 2024-05-07 | Velico Medical, Inc. | Blood plasma product |
| US11841189B1 (en) | 2022-09-15 | 2023-12-12 | Velico Medical, Inc. | Disposable for a spray drying system |
| US12246266B2 (en) | 2022-09-15 | 2025-03-11 | Velico Medical, Inc. | Disposable for a spray drying system |
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| US2441730A (en) * | 1944-05-30 | 1948-05-18 | Us Director Of The Office Of S | Method and means for preservation of blood plasma and the like by freezing and drying |
| DE1625658U (de) | 1951-04-27 | 1951-07-19 | Fein C & E | Hebelschalter zur unterbrechung von zwei stromphasen in verbindung mit dem handgriff eines elektrowerkzeugs. |
| US3162019A (en) * | 1962-11-16 | 1964-12-22 | Bethlehem Steel Corp | Method and apparatus for freezing liquids to be used in a freeze-drying process |
| FR1406556A (fr) * | 1964-06-08 | 1965-07-23 | Thomson Houston Comp Francaise | Perfectionnements apportés aux installations de lyophilisation |
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| US4077227A (en) | 1976-11-12 | 1978-03-07 | Regents Of The University Of Minnesota | Method of freezing liquid material in which agglomeration is inhibited |
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-
2005
- 2005-07-09 CA CA2574614A patent/CA2574614C/en not_active Expired - Fee Related
- 2005-07-09 US US11/572,461 patent/US7836606B2/en not_active Expired - Lifetime
- 2005-07-09 DK DK05769919.1T patent/DK1794524T3/da active
- 2005-07-09 EP EP05769919A patent/EP1794524B1/en not_active Expired - Lifetime
- 2005-07-09 AT AT05769919T patent/ATE542095T1/de active
- 2005-07-09 JP JP2007521842A patent/JP4829229B2/ja not_active Expired - Fee Related
- 2005-07-09 WO PCT/EP2005/007455 patent/WO2006008006A1/en not_active Ceased
- 2005-07-09 AU AU2005263465A patent/AU2005263465B2/en not_active Ceased
-
2007
- 2007-01-23 IL IL180898A patent/IL180898A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| CA2574614A1 (en) | 2006-01-26 |
| IL180898A0 (en) | 2007-07-04 |
| IL180898A (en) | 2011-10-31 |
| JP2008507307A (ja) | 2008-03-13 |
| US7836606B2 (en) | 2010-11-23 |
| EP1794524B1 (en) | 2012-01-18 |
| AU2005263465B2 (en) | 2010-07-29 |
| WO2006008006A1 (en) | 2006-01-26 |
| AU2005263465A1 (en) | 2006-01-26 |
| DK1794524T3 (da) | 2012-04-16 |
| EP1794524A1 (en) | 2007-06-13 |
| JP4829229B2 (ja) | 2011-12-07 |
| ATE542095T1 (de) | 2012-02-15 |
| US20080060213A1 (en) | 2008-03-13 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20220711 |