JP2008501347A - 使い捨て可能なバイオリアクターシステムおよび方法 - Google Patents
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Abstract
Description
本出願は、2004年6月4日(2005年6月4日は土曜日である)に出願された、発明の名称「DISPOSABLE BIOREACTOR」の米国特許仮出願60/577,143号、および2005年4月7日に出願された、表題「MIXING SYSTEM PATENT APPLICATION」の米国特許仮出願第60/669,252号の利益を主張する。これら両方の開示は、その全体が参考とて本明細書中で援用される。本出願はまた、2005年2月3日に出願した、同時係属中の米国特許出願第11/050,133号に関連する。この開示全体は、本明細書中で参考として援用される。
本発明の実施形態は、生物学的物質を処理するための方法およびシステムに関し、そしてより具体的には、生物学的物質を処理するための、使い捨て可能な構成要素/システムに関する。
従来のバイオリアクターは、いくつかの代替手段によって混合され得る一定に加圧される容器として設計されるが、現在の使い捨て可能なバイオリアクターは、プラスチックの滅菌バッグを利用するデバイスである。各々は、生物学的物質を処理するため(例えば、植物細胞、動物細胞を増殖させるため)に使用される。例えば、哺乳動物細胞、植物細胞または昆虫細胞および微生物培養物を含む。このようなデバイスはまた、無菌的混合適用および非無菌混合適用のために使用され得る。
従って、本発明の実施形態は、従来技術のバイオリアクターシステムの不利な点および未到達の点に取り組み、そして改善した使い捨て可能なバイオリアクターシステムを示す。特に、本発明の実施形態は、混合、通気および/またはプロセス制御を提供し、バイオリアクターを稼動させるために必要とされる実質的に多くの(例えば、大部分の)代表的なユーティリティーが排除された。
バイオプロセス容器はバイオリアクターに関して生成物接触表面を形成する。この容器は、好ましくは、支持のためのタンク外壁のような強固な構造物に入れられ得る、可撓性のバッグである。この支持構造物はまた、物質の処理前、処理中および処理後にこのバイオリアクターシステムが異なる位置へと移動され得るように、台車を備え/含み得る。
以下は、本発明の実施形態に従う、使い捨て可能なバイオリアクターバッグを有する例示的なバイオリアクターシステムのための構成要素のリストである(また、図1Bを参照のこと)
Claims (29)
- バイオリアクターシステムであって:
処理のために生物物質を収容する、使い捨て可能な容器であって、該使い捨て可能な容器は、少なくとも1つの流入口、少なくとも1つの排出口を備える、使い捨て可能な容器;
少なくとも1つの収集口;
該使い捨て可能な容器を支持するための、構造物;
1つ以上のセンサであって、該容器の中の生物物質の1つ以上のパラメータを感知するための1つ以上のセンサ;
該容器の内容物を加熱するためのヒーターであって、サーモスタットを備える、ヒーター;
混合システムであって、該使い捨て可能な容器の中に収容される該生物物質が混合されるように、該システムと配置される、混合システム、
を備える、システム。 - 前記使い捨て可能な容器がプラスチック容器または可撓性のプラスチックバッグを含む、請求項1に記載のバイオリアクター。
- 前記使い捨て可能な容器が1つ以上のバッフルを備える、請求項1に記載のバイオリアクター。
- 前記混合システムが、前記容器の内部に配置される、仕切りと繋がれた気泡塔を備える、請求項1に記載のバイオリアクター。
- 前記混合手段が、前記容器の下側部分において該容器の中に配置されたインペラを備え、該容器の外部のモーターによって駆動される、請求項1に記載のバイオリアクター。
- 前記インペラが前記モーターと磁力で繋げられる、請求項5に記載のバイオリアクター。
- 前記インペラが前記モーターと機械的に繋げられる、請求項5に記載のバイオリアクター。
- 前記ヒーターが、前記使い捨て可能な容器を保持する容器の外側に配置される物質の領域を備える、請求項1に記載のバイオリアクター。
- 前記ヒーターが、前記使い捨て可能な容器を保持する容器の外側上の少なくとも一部の周りに覆われた、熱水もしくは冷水を収容する物質のブランケットまたは金属のジャケットを備える、請求項1に記載のバイオリアクター。
- 前記ヒーターが前記使い捨て可能な容器の内側または外側に配置される、請求項9に記載のバイオリアクター。
- 前記1つ以上のセンサが、溶存酸素、溶存二酸化炭素、混合速度、ガス流量、温度、pHおよび圧力のうちの少なくとも1つを検出するためのセンサを含む、請求項1に記載のバイオリアクター。
- 前記システムを制御するためのコンピューターをさらに備える、請求項1に記載のバイオリアクターシステム。
- 空気供給、二酸化炭素供給、および酸素供給のうちの少なくとも1つをさらに備える、請求項1に記載のバイオリアクターシステム。
- 前記支持構造物を移動させるための輸送手段をさらに備える、請求項1に記載のバイオリアクターシステム。
- 前記輸送手段が台車を含む、請求項14に記載のバイオリアクターシステム。
- バイオリアクターシステムであって、
支持構造物;
該支持構造物内に配置される可撓性プラスチックバッグ
を備え、該使い捨て可能な容器は、
該可撓性プラスチックバッグの下側部分に取り付けられるインペラプレートであって、支柱を備える、インペラプレート;
該支柱に装着されるインペラハブであって、該インペラハブは、該支柱上に配置される少なくとも1つのインペラブレードを有し、かつ少なくとも1つの磁石を有する、インペラハブ;
を備える、可撓性プラスチックバッグ;
シャフトを有するモーターであって、該モーターは該支持構造物に隣接するかまたは該支持構造物内に提供される、モーター;
該モーターシャフト上に装着されるモーターハブであって、少なくとも1つの磁石を備える、モーターハブ;
を備え、ここで該支持構造物内の該可撓性バッグの取り付けの際に、該モーターハブは、該モーターシャフトが回転する場合に該インペラハブを駆動するように、該モーターハブの磁石が該インペラハブの磁石と整列し得るように、該インペラプレートと整列する、バイオリアクターシステム。 - 前記モーターハブはレイジー・スーザンベアリングさらに備え、該ベアリングは、該ベアリングの一部を該インペラプレートの一面と接するように該ハブ内に配置される、請求項16に記載のバイオリアクターシステム。
- 前記インペラプレートは、前記可撓性プラスチックバッグの内部と該可撓性プラスチックバッグの外部との間に一方向性または双方向性に流体連絡させるように配置された、少なくとも1つの多孔性構成要素をさらに備える、請求項16に記載のバイオリアクター。
- 前記流体連絡は、前記可撓性プラスチックバッグの内面に散布ガスを導入する工程、または該可撓性プラスチックバッグの内側から流体を除去する工程を包含する、請求項18に記載のバイオリアクターシステム。
- 前記少なくとも1つのインペラブレードが、可変性のピッチのインペラブレードを備える、請求項16に記載のバイオリアクターシステム。
- 前記インペラブレードの前記ピッチが、前記インペラハブの回転速度に応じて変化する、請求項20に記載のバイオリアクターシステム。
- 前記インペラブレードの前記ピッチが手動で調節される、請求項20に記載のバイオリアクターシステム。
- バイオリアクターシステムであって、
支持構造物;
該支持構造物内に配置される可撓性プラスチックバッグであって、該使い捨て可能な容器は、
該可撓性プラスチックバッグの下側部分に添えられるインペラプレート
該可撓性プラスチックバッグの内部に配置される第一末端を有し、そして該可撓性プラスチックバッグの外部に配置される第二末端を有する、第一シャフト;
該シャフトを囲む、シール;
該シャフトの第一末端に取り付けられるインペラハブであって、該シャフト上に配置される少なくとも1つのインペラブレードを有する、インペラハブ;
を備える、使い捨て可能な容器;
該支持構造物内に該可撓性プラスチックバッグを取り付ける際に、該支持構造物に隣接してかまたは該支持構造物内に配置されるモーターであって、該シャフトの該第二末端が該モーターによって駆動される、モーター、
を備える、バイオリアアクターシステム。 - 前記インペラプレートおよび/または前記シールがベアリングを備える、請求項23に記載のバイオリアクターシステム。
- 前記インペラプレートは、前記可撓性プラスチックバッグの内部と該可撓性プラスチックバッグの外部との間に1方向または双方向の流体連絡を可能にするように配置される、少なくとも1つの多孔性構成要素をさらに備える、請求項23に記載のバイオリアクターシステム。
- 前記流体連絡が、前記可撓性プラスチックバッグの内部にガス散布を導入する工程、または該可撓性プラスチックバッグの内部から流体を取り出す工程を包含する、請求項25に記載のバイオリアクターシステム。
- 前記少なくとも1つのインペラブレードが可変性のピッチのインペラブレードを備える、請求項23に記載のバイオリアクターシステム。
- 前記インペラブレードの前記ピッチが、前記インペラハブの回転速度に応じて変化する、請求項27に記載のバイオリアクターシステム。
- 前記インペラブレードの前記ピッチが手動で調節される、請求項27に記載のバイオリアクターシステム。
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Also Published As
Publication number | Publication date |
---|---|
WO2005118771A2 (en) | 2005-12-15 |
EP1773976B1 (en) | 2016-12-07 |
US7629167B2 (en) | 2009-12-08 |
CA2569405A1 (en) | 2005-12-15 |
HK1112479A1 (en) | 2008-09-05 |
CN101001945A (zh) | 2007-07-18 |
AU2005250500A1 (en) | 2005-12-15 |
AU2005250500B2 (en) | 2011-06-23 |
DK1773976T3 (en) | 2017-01-30 |
EP1773976A2 (en) | 2007-04-18 |
EP1773976B2 (en) | 2020-01-01 |
CN102492607B (zh) | 2014-12-10 |
ES2612212T3 (es) | 2017-05-12 |
BRPI0510648A (pt) | 2007-11-20 |
CN101001945B (zh) | 2012-02-08 |
CA2569405C (en) | 2011-05-03 |
KR101021203B1 (ko) | 2011-03-11 |
MXPA06014099A (es) | 2007-05-09 |
CN102492607A (zh) | 2012-06-13 |
ES2612212T5 (es) | 2020-06-25 |
DK1773976T4 (da) | 2020-02-10 |
CR8769A (es) | 2007-08-28 |
KR20070053200A (ko) | 2007-05-23 |
JP4680990B2 (ja) | 2011-05-11 |
BRPI0510648B1 (pt) | 2016-04-26 |
US20050272146A1 (en) | 2005-12-08 |
NO20070069L (no) | 2007-03-05 |
WO2005118771A3 (en) | 2006-02-02 |
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