JP5728135B2 - 凍結乾燥粒子製造用プロセスライン - Google Patents
凍結乾燥粒子製造用プロセスライン Download PDFInfo
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- JP5728135B2 JP5728135B2 JP2014533796A JP2014533796A JP5728135B2 JP 5728135 B2 JP5728135 B2 JP 5728135B2 JP 2014533796 A JP2014533796 A JP 2014533796A JP 2014533796 A JP2014533796 A JP 2014533796A JP 5728135 B2 JP5728135 B2 JP 5728135B2
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Classifications
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- 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
-
- 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
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)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Vaporization, Distillation, Condensation, Sublimation, And Cold Traps (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Inorganic Compounds Of Heavy Metals (AREA)
- Oxygen, Ozone, And Oxides In General (AREA)
- Physical Or Chemical Processes And Apparatus (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Compounds Of Alkaline-Earth Elements, Aluminum Or Rare-Earth Metals (AREA)
Description
(1)粒子状補助剤。例えば、リポソーム、特にカチオン性リポソーム(例えばDC−Chol(例えば米国特許出願公開第2006/0165717号明細書を参照)、DOTAP、DDAB及び1,2−ジアルカノイル−sn−グリセロ−3−エチルホスホコリン(エチルPC)リポソーム(米国特許第7,344,720号明細書を参照))、脂質ミセルもしくは界面活性剤ミセル又は他の脂質粒子(例えばCSL社又はイスコノバ社(Isconova)のIscomatrix(商標)、ビロソーム、プロテオコキレート)、ポリマ―ナノ粒子又は微粒子(例えばPLGA及びPLAナノ粒子又は微粒子、PCPP粒子、アルギン酸/キトサン粒子)又は可溶性ポリマー(例えばPCPP、キトサン)、髄膜炎菌プロテオソーム等のタンパク質粒子、鉱物ゲル(標準的なアルミニウム補助剤:AlOOH,AlPO4)、微粒子又はナノ粒子(例えばCa3(PO4)2)、ポリマー/アルミニウムナノハイブリッド(例えばPMAA−PEG/AlOOH及びPMAA−PEG/AlPO4ナノ粒子)水中油型乳剤(例えばノバルティス社(Novartis)のMF59,グラクソスミスクライン・バイオロジカルズ社(GlaxoSmithKline Biologicals)のAS03)、及び油中水型乳剤(例えばセピック社(Seppic)のISA51及びISA720、又は国際公開第2008/009309号に開示されているようなもの)。例えば、本発明に係るプロセスに適している補助剤となる乳剤は、国際公開第2007/006939号に開示されているものである。
本願は、欧州特許出願番号第11008057.9−1266号に基づく優先権を主張し、その請求項の主題を、完全性のために以下に列挙する。
液滴を生成し、該液滴を凍結凝固させて粒子を形成する噴霧チャンバと、
前記粒子を凍結乾燥するバルク凍結乾燥器(304)と
を別個の装置として備え、
前記噴霧チャンバから前記凍結乾燥器へ生成物移送を行う移送部が設けられ、
前記粒子の製造を端から端までの閉鎖状態下で行うために、前記装置と前記移送部とはそれぞれ、閉鎖された作業工程を行うように別個に構成されている、プロセスライン。
(項目9)前記凍結乾燥器は真空凍結乾燥器である、項目1〜8のいずれか1項目に記載のプロセスライン。
(項目11)前記プロセスラインの前記1つ以上の移送部のうちの少なくとも1つは、少なくとも1つの温度制御された壁を備える、項目1〜10のいずれか1項目に記載のプロセスライン。
(項目13)項目1〜12のいずれか1項目に記載のプロセスラインによって実行される、閉鎖状態下で凍結乾燥粒子を製造するプロセスであって、該プロセスは、
噴霧チャンバ内で液滴を生成して、該液滴を凍結凝固させて粒子を形成するステップと、
生成物を閉鎖状態下で噴霧チャンバから移送部を介して凍結乾燥器へ移送するステップと、
凍結乾燥器内で粒子をバルクウェアとして凍結乾燥するステップと
を少なくとも含み、
端から端までの閉鎖状態下で前記粒子を製造するために、前記装置及び前記移送部の各々が閉鎖状態下で別個に作動する、プロセス。
(項目15)前記噴霧チャンバと前記凍結乾燥器とを作動可能な状態で分離して、前記分離された装置の一方にCiP及び/又はSiPを行うステップを含む、項目13又は14に記載のプロセス。
Claims (22)
- 閉鎖状態下で凍結乾燥粒子を製造するプロセスラインであって、前記プロセスラインは少なくとも、
液滴を生成し、該液滴を凍結凝固させて粒子を形成する噴霧チャンバと、
前記粒子を凍結乾燥するバルク凍結乾燥器と
を別個のプロセス装置として備え、
前記噴霧チャンバから前記凍結乾燥器へ生成物移送を行う移送部が設けられ、
前記粒子の製造を端から端までの閉鎖状態下で行うために、前記プロセス装置と前記移送部とはそれぞれ、閉鎖された作業工程を行うように別個に構成され、
前記噴霧チャンバは、向流式又は並流式の冷却流を回避するために、前記液滴を凍結させるための唯一の冷却要素として冷却された内壁を備えることにより、前記粒子の凍結凝固のために任意の冷却システムから前記液滴を分離するように構成される、プロセスライン。 - 閉鎖状態下で凍結乾燥粒子を製造するプロセスラインであって、前記プロセスラインは少なくとも、
液滴を生成し、該液滴を凍結凝固させて粒子を形成する噴霧チャンバと、
前記粒子を凍結乾燥するバルク凍結乾燥器と
を別個のプロセス装置として備え、
前記噴霧チャンバから前記凍結乾燥器へ生成物移送を行う移送部が設けられ、
前記粒子の製造を端から端までの閉鎖状態下で行うために、前記プロセス装置と前記移送部とはそれぞれ、閉鎖された作業工程を行うように別個に構成され、
前記噴霧チャンバは、向流式又は並流式の冷却流を回避するために、前記液滴を凍結させるための唯一の冷却要素として冷却された内壁を備えることにより、前記粒子の凍結凝固のために任意の冷却システムから前記液滴を分離するように構成され、
前記プロセス装置及び前記移送部が、前記生成物の滅菌性を端から端まで保護し、かつ/又は、前記生成物の端から端までの封込を行う統合プロセスラインを構成する、プロセスライン。 - 前記移送部は前記2つのプロセス装置を永久的に相互接続して、端から端までの閉鎖状態下で前記粒子を製造する統合プロセスラインを構成する、請求項1又は2に記載のプロセスライン。
- 前記移送部は、前記接続された2つのプロセス装置のうちの少なくとも一方が、前記プロセスラインの一体性には影響を与えずに他方のプロセス装置から切り離されて、閉鎖状態下で作動可能であるように、前記2つのプロセス装置を作動可能な状態で互いから分離する手段を備える、請求項3に記載のプロセスライン。
- 前記プロセス装置と前記移送部のうちの少なくとも1つは、密閉された処理体積部内部において所定の処理条件を提供するように構成された隔壁を備え、前記隔壁は、前記処理体積部と前記プロセス装置の環境とを互いに隔てるように構成される、請求項1〜4のいずれか1項に記載のプロセスライン。
- 前記プロセス装置及び前記移送部は、前記生成物の滅菌性を端から端まで保護し、かつ/又は、前記生成物の端から端までの封込を行う統合プロセスラインを構成する、請求項1、及び3〜5のいずれか1項に記載のプロセスライン。
- 前記凍結乾燥器は、閉鎖状態下で分離された作業工程を行うように構成されており、前記分離された作業工程には、粒子の凍結乾燥、凍結乾燥器の洗浄、及び凍結乾燥器の滅菌のうちの少なくとも1つを含む、請求項1〜6のいずれか1項に記載のプロセスライン。
- 前記プロセスラインは、さらなるプロセス装置として、閉鎖状態下で、生成物のプロセスラインからの排出、生成物サンプルの取り出し、及び、生成物の加工のうちの少なくとも1つを行うように構成される、生成物処理装置を備える、請求項1〜7のいずれか1項に記載のプロセスライン。
- 前記噴霧チャンバは、前記液滴を凍結凝固させる少なくとも1つの温度制御された壁を備える、請求項1〜8のいずれか1項に記載のプロセスライン。
- 前記凍結乾燥器は真空凍結乾燥器である、請求項1〜9のいずれか1項に記載のプロセスライン。
- 前記凍結乾燥器は前記粒子を受け取るための回転式ドラムを備える、請求項1〜10のいずれか1項に記載のプロセスライン。
- 前記プロセスラインの1つ以上の移送部のうちの少なくとも1つは、少なくとも1つの温度制御された壁を備える、請求項1〜11のいずれか1項に記載のプロセスライン。
- 前記プロセスライン全体が定置洗浄「CiP」及び/又は定置滅菌「SiP」を行うように構成される、請求項1〜12のいずれか1項に記載のプロセスライン。
- 前記液滴は、凍結粒子を形成するために、前記噴霧チャンバ内における落下中に凍結する、請求項1〜13のいずれか1項に記載のプロセスライン。
- 請求項1〜14のいずれか1項に記載のプロセスラインによって実行される、閉鎖状態下で凍結乾燥粒子を製造するプロセスであって、前記プロセスは、
噴霧チャンバ内で液滴を生成して、該液滴を凍結凝固させて粒子を形成するステップと、
前記生成物を閉鎖状態下で前記噴霧チャンバから移送部を介して凍結乾燥器へ移送するステップと、
前記凍結乾燥器内で前記粒子をバルクウェアとして凍結乾燥するステップと
を少なくとも含み、
端から端までの閉鎖状態下で前記粒子を製造するために、前記プロセス装置及び前記移送部の各々は閉鎖された作業工程を行うように別個に構成される、プロセス。 - 前記凍結乾燥器への生成物移送は、前記噴霧チャンバ内での液滴の生成及び凍結凝固と並行して行われる、請求項15に記載のプロセス。
- 前記噴霧チャンバと前記凍結乾燥器を作動可能な状態で分離して、前記分離されたプロセス装置の一方にCiP及び/又はSiPを行うステップを含む、請求項15又は16に記載のプロセス。
- 前記液滴は、凍結粒子を形成するために、前記噴霧チャンバ内における落下中に凍結する、請求項15〜17のいずれか1項に記載のプロセス。
- 凍結乾燥粒子の形態の1つ以上の抗原を含むワクチン組成物を調合するプロセスであって、
前記1つ以上の抗原を含む液体バルク溶液を、請求項15〜18のいずれか1項に記載のプロセスにより凍結乾燥することと、
得られた前記凍結乾燥粒子を受取容器に充填することと
を含むプロセス。 - 凍結乾燥粒子の形態の1つ以上の抗原を含む補助剤含有ワクチン組成物を調合するプロセスであって、
(a)前記補助剤と前記1つ以上の抗原とを含む液体バルク溶液を請求項15〜18のいずれか1項に記載のプロセスによって凍結乾燥することと、
(b)得られた凍結乾燥粒子を受取容器に充填することと
を含む、
あるいは、前記(a)の液体バルク溶液が前記補助剤を含んでいない場合には、
(c)前記補助剤の液体バルクと前記1つ以上の抗原を含む液体バルク溶液とを請求項15〜18のいずれか1項に記載のプロセスにより別個に凍結乾燥することと、
(d)前記1つ以上の抗原の凍結乾燥粒子を前記補助剤の凍結乾燥粒子と配合することと、
(e)前記凍結乾燥粒子の配合物を受取容器に充填することと
を含む、プロセス。 - 前記プロセスの全ステップが滅菌状態下で実施される、請求項19又は20に記載のプロセス。
- 前記凍結乾燥粒子は滅菌状態にある、請求項19〜21のいずれか1項に記載のプロセス。
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EP11008057.9 | 2011-10-05 | ||
EP11008057.9A EP2578974A1 (en) | 2011-10-05 | 2011-10-05 | Process line for the production of freeze-dried particles |
PCT/EP2012/004168 WO2013050162A1 (en) | 2011-10-05 | 2012-10-04 | Process line for the production of freeze-dried particles |
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