JP6936937B2 - 細胞および/または細胞生成物の製造システム、製造装置および製造方法 - Google Patents
細胞および/または細胞生成物の製造システム、製造装置および製造方法 Download PDFInfo
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- JP6936937B2 JP6936937B2 JP2017559911A JP2017559911A JP6936937B2 JP 6936937 B2 JP6936937 B2 JP 6936937B2 JP 2017559911 A JP2017559911 A JP 2017559911A JP 2017559911 A JP2017559911 A JP 2017559911A JP 6936937 B2 JP6936937 B2 JP 6936937B2
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Description
以下に、用語の意味を記載する。
以下、添付図面を参照して、本発明のシステムおよび方法を説明する。
このシステムに固定してもよく、あるいは着脱自在に取り付けてもよい、細胞を培養する少なくとも一つのバイオリアクター2を有する少なくとも一つの細胞培養ユニット1、
細胞培養ユニット1に少なくとも流体接続する、細胞成長パラメーターを制御する少なくとも一つの操作制御ユニット3、および
細胞培養ユニット1に流体接続した、周囲空気を処理する少なくとも一つの空気処理ユニット8を有する製造システムである(図1)。細胞培養ユニット1および操作制御ユニット3は少なくとも一つの共通壁21を有し、細胞培養ユニット1および空気処理ユニット8も少なくとも一つの共通壁(図1の20)を有する。
OTR=KLa(Cgas−Cliq)
式中 OTR=酸素移動速度(単位:μmolO2l−1h−1
KLa=酸素移動係数(単位:h−1)
Cgas=気相O2(平衡)濃度(単位:μM)
Cliq=液相O2濃度(単位:μM)
培地レザーバーに流体接続し、細胞培養ユニットに設けた少なくとも一つのバイオリアクターで細胞を培養する工程、
少なくとも2種類の気体の混合物を上記バイオリアクターに供給する工程、および
無菌の周囲空気を上記細胞培養ユニットに供給する工程を有し、
上記バイオリアクターの総容量が1000L以下である統合化自動方法を提供するものである。
infliximab、adalimumab、basiliximab、daclizymab、omalizumab、palivizumabやabciximabなどの抗炎症性バイオ分子や任意の抗体;
gemtuzumab、alemtuzumab、rituximab、transuzumab、nimotuzumab、cetuximabやbevacizumabなどの抗癌剤バイオ分子;
制限するわけではないが、ポリオワクチン(IPV)、ロタウイルスワクチン、インフルエンザワクチン、黄熱ワクチン、水痘ワクチン、麻疹ワクチン、おたふくかぜワクチン、風疹ワクチン、肝炎ワクチンや狂犬病ワクチンなどのヒト用ワクチン;および
制限するわけではないが、マレクワクチンやニューカスルワクチンなどの獣医学ワクチン。本発明の方法およびシステムはRSV−抗体系ワクチンやこれらの製剤の製造にも使用できる。
2:バイオリアクター
3:操作制御ユニット
4:気体発生手段
5:動作手段
6:測定手段
7、9:供給手段
7:ポンプモーター
8:空気処理ユニット
9:ポンプヘッド
10:サンプリングマニホルド
11:回収ライン
12:気体供給ライン
13、22、31、39:管
13:培地供給ライン
15:注入パイプ、供給ライン、導入パイプ
16:培地レザーバー
17:車輪
18:殺菌フィルター
20、21:壁部、共通壁
23:フィルター
30:下流側ユニット
32:精製手段
35:導出側管
37:ろ過手段
Claims (24)
- 総容量が1000L以下の、細胞を培養する少なくとも一つのバイオリアクターを有する少なくとも一つの細胞培養ユニット、
この細胞培養ユニットに少なくとも流体接続し、細胞成長パラメーターを制御する少なくとも一つの操作制御ユニット、および
前記細胞培養ユニットに流体接続し、周囲空気を処理する少なくとも一つの空気処理ユニットを有し、
前記空気処理ユニットが殺菌された空気を層流として前記細胞培養ユニットに供給する少なくとも一つの殺菌手段を有することを特徴とする細胞および/または細胞生成物の製造システム。
- 前記バイオリアクターの総容量が900L以下、好ましくは800L以下、より好ましくは700L以下、さらにより好ましくは450L以下、さらにより好ましくは300L以下、さらにより好ましくは250L以下、最適には200L以下であり、かつ、前記バイオリアクターの総容量が少なくとも1.5L、好ましくは少なくとも3L、より好ましくは少なくとも10L、さらにより好ましくは少なくとも30L、最適には少なくとも50L、より最適には少なくとも60Lである請求項1に記載のシステム。
- 前記操作制御ユニットが前記バイオリアクターに動作を与える少なくとも一つの動作手段を有し、この動作手段が前記バイオリアクターに機械的および/または磁気的に接続され、左右動作、上下動作、前記バイオリアクターの水平軸にそった回動、前記バイオリアクターの垂直軸にそった回動、前記バイオリアクターの傾斜水平軸にそった搖動やこれら動作を組み合わせた動作から選択される動作を行う請求項1又は2に記載のシステム。
- 前記操作制御ユニットが前記バイオリアクターに、かつ培地レザーバーに接続され、前記バイオリアクターに培地を供給する少なくとも一つの供給手段を有し、この培地レザーバーを前記システムの外部に設けた請求項1〜3のいずれか1項に記載のシステム。
- 前記操作制御ユニットが、複数の細胞培養パラメーターを測定する少なくとも一つの測定手段を有する請求項1〜4のいずれか1項に記載のシステム。
- 前記操作制御ユニットが、前記バイオリアクターに流体接続した少なくとも一つの気体生成手段を有し、この気体生成手段が少なくとも2種類の異なる気体を混合する少なくとも一つの気体混合装置を有する請求項1〜5のいずれか1項に記載のシステム。
- 前記細胞培養ユニット内部に所定の温度及び/又は所定の圧力を一定に維持する請求項1〜6のいずれか1項に記載のシステム。
- 前記バイオリアクターがマイクロ線維、中空フィルター、タンジェンシャルフローフィルター、セトラーやこれらの組み合わせからなる系列から選択される少なくとも一つの細胞取り込みシステムを有し、前記細胞取り込みシステムが、前記バイオリアクター1Lにつき少なくとも1000m2、好ましくは少なくとも100m2、より好ましくは少なくとも10m2の細胞成長表面を与える請求項1〜7のいずれか1項に記載のシステム。
- 適宜、前記細胞培養ユニットに流体接続した少なくとも一つの下流側ユニットを有し、この下流側ユニットが少なくとも一つのろ過手段、少なくとも一つの収穫手段、少なくとも一つの透析手段、少なくとも一つのバイオ分子精製手段および少なくとも一つのタンパク質濃縮ユニット、あるいはこれらの手段を組み合わせたものからなる群から選択するプラグ接続可能な手段を有する請求項1〜8のいずれか1項に記載のシステム。
- さらに、電気機械的に前記システムに接続され、機能を制御および/またはモニターする少なくとも一つのプログラム可能な制御装置を有する請求項1〜9のいずれか1項のシステム。
- 携帯可能で清潔なルームに好適な単独の携帯可能なチャンバー内で実施する請求項1〜10のいずれか1項に記載のシステム。
- 細胞および/または細胞生成物の統合的かつ自動的な製造方法において
(a)培地レザーバーに流体接続し、細胞培養ユニットに設けられた少なくとも一つのバイオリアクターで細胞を培養する工程、
(b)少なくとも2種類の気体の混合物をバイオリアクターに供給する工程、および
(c)前記細胞培養ユニットに殺菌された周囲空気を供給し、殺菌された空気は細胞培養ユニットへ流体接続する殺菌ユニットによって層流として送られる工程、を有し、
前記バイオリアクターの総容量が1000L以下であることを特徴とする前記製造方法。
- 前記バイオリアクターの総容量が900L以下、好ましくは800L以下、より好ましく700L以下、さらにより好ましくは450L以下、最適には300L以下、より最適には250L以下、さらにより最適には200L以下であり、かつ、前記バイオリアクターの総容量が少なくとも1.5L、好ましくは少なくとも3L、より好ましくは少なくとも10L、さらにより好ましくは少なくとも30L、最適には少なくとも50L、より最適には少なくとも60Lである請求項12に記載の方法。
- 細胞培養時、前記バイオリアクターに動作を与え、この動作を左右動作、上下動作、前記バイオリアクターの水平軸にそった回動、前記バイオリアクターの垂直軸にそった回動、前記バイオリアクターの傾斜水平軸にそった搖動やこれら動作を組み合わせた動作から選択する請求項12又は13に記載の方法。
- 前記細胞培養ユニット内部に所定の温度及び/又は所定の圧力を一定に維持する請求項12〜14のいずれか1項に記載の方法。
- さらに、細胞数密度が少なくとも5千万/mlにおいて前記バイオリアクターを下流側ユニットおよび/または成長細胞に流体接続する工程を有する請求項12〜15のいずれか1項に記載の方法。
- 前記下流側ユニットが、前記バイオリアクターから連続モードで補給された培地を受け取り、前記補給された培地が培地および/または培養された細胞および/またはタンパク質、ペプチド類および/または細胞膜などの細胞溶解から誘導された任意の他の細胞バイオ分子を有する培養生成物を有する請求項12〜16のいずれか1項に記載の方法。
- 前記下流側ユニットが、前記バイオリアクターから補給された培地を1000ml/分以下の量で受け取る請求項12〜17のいずれか1項に記載の方法。
- プログラム可能な制御装置によって完全制御する請求項12〜18のいずれか1項に記載の方法。
- 前記供給手段がモーターとポンプヘッドとを有する蠕動ポンプを備え、この蠕動ポンプの前記モーターは前記操作制御ユニットの中に有り、一方、前記ポンプヘッドは前記細胞培養ユニットの中に有る請求項4に記載のシステム。
- 前記操作制御ユニットの測定手段として、バイオリアクターの外側に一つ以上のセンサーを含む請求項1〜11および請求項20のいずれか1項に記載のシステム。
- 前記殺菌手段が空調式のHVACシステムを含む請求項1〜11および請求項20〜21のいずれか1項に記載のシステム。
- 前記細胞培養ユニットに流体接続した少なくとも一つの下流側ユニットを含む請求項1〜11および請求項20〜22のいずれか1項に記載のシステム。
- 前記細胞培養ユニットが少なくとも一つの下流側ユニットとの流体接続に適合した請求項1〜11および請求項20〜22のいずれか1項に記載のシステム。
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KR20140096051A (ko) * | 2011-10-07 | 2014-08-04 | 폴 테크놀로지 유케이 리미티드 | 유체 처리 제어 시스템 및 이와 관련된 방법 |
DE102012200938B4 (de) * | 2012-01-23 | 2016-08-18 | Alpha Plan Gmbh | Bio- und medizintechnisches Baukastensystem |
EP2639294A1 (fr) * | 2012-03-15 | 2013-09-18 | CellProthera | Automate et procédé automatisé de culture cellulaire |
ES2435092B1 (es) * | 2012-06-14 | 2014-09-09 | Aglaris Cell S.L. | Método y sistema de cultivo celular |
CN103194390B (zh) * | 2013-04-19 | 2014-08-06 | 南方医科大学南方医院 | 双环路振荡灌注式生物反应系统 |
CN103480276B (zh) * | 2013-09-06 | 2015-09-02 | 北京科兴生物制品有限公司 | 一种封闭式超滤管道系统及其应用 |
CN103525699B (zh) * | 2013-10-22 | 2015-03-04 | 中国人民解放军第二一〇医院 | 一种细胞暴露特定气体精确控制装置 |
CN104017727B (zh) * | 2014-06-04 | 2016-03-30 | 奥星制药设备(石家庄)有限公司 | 一次性无菌细胞培养袋配套细胞培养系统 |
CN107043701A (zh) * | 2017-05-26 | 2017-08-15 | 奥凯(苏州)生物技术有限公司 | 一种提高细胞接种分散性的细胞扩增系统 |
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EP3256565A1 (en) | 2017-12-20 |
BR112017016986A2 (pt) | 2018-04-03 |
US20180030398A1 (en) | 2018-02-01 |
JP2018504931A (ja) | 2018-02-22 |
US20220017850A1 (en) | 2022-01-20 |
MX2017010217A (es) | 2017-11-10 |
AU2016218037A1 (en) | 2017-09-21 |
CN107532132A (zh) | 2018-01-02 |
WO2016128361A1 (en) | 2016-08-18 |
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