JP2020505940A - 細胞培養システム及び方法 - Google Patents
細胞培養システム及び方法 Download PDFInfo
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Abstract
Description
[0001]本出願は、参照により本明細書に組み込まれている2017年2月10日出願の米国仮特許出願シリアル番号第62/457,341号に基づき、その優先権を主張する。
ボトックス(Combotox)、コレシストキニン−B/ガストリン受容体結合ペプチド、111In−hEGF、AE−37、トラスツズマブ(trasnizumab)1−DM1、アンタゴニストG、IL−12(組換え)、PM−02734、IMP−321、rhlGF−BP3、BLX−883、CUV−1647(局所用)、L−19に基づく放射免疫療法(がん)、Re−188−P−2045、AMG−386、DC/1540/KLHワクチン(がん)、VX−001、AVE−9633、AC−9301、NY−ESO−1ワクチン(ペプチド)、NA17.A2ペプチド、メラノーマワクチン(パルス式抗原治療)、前立腺がんワクチン、CBP−501、組換えヒトラクトフェリン(ドライアイ)、FX−06、AP−214、WAP−8294A(注入用)、ACP−HIP、SUN−11031、ペプチドYY[3−36](肥満、鼻腔内)、FGLL、アタシセプト、BR3−Fc、BN−003、BA−058、ヒト副甲状腺ホルモン1−34(鼻腔用、骨粗鬆症)、F−18−CCR1、AT−1100(セリアック病/糖尿病)、JPD−003、PTH(7−34)リポソームクリーム(Novasome)、デュラマイシン(眼科用、ドライアイ)、CAB−2、CTCE−0214、グリコペグ化エリスロポエチン、EPO−Fc、CNTO−528、AMG−114、JR−013、第XIII因子、アミノカンジン、PN−951、716155、SUN−E7001、TH−0318、BAY−73−7977、テベレリクス(即時放出)、EP−51216、hGH(制御放出、Biosphere)、OGP−I、シフビルチド、TV4710、ALG−889、Org−41259、rhCC10、F−991、チモペンチン(肺疾患)、r(m)CRP、肝臓選択性インスリン、スバリン、L19−IL−2融合タンパク質、エラフィン、NMK−150、ALTU−139、EN−122004、rhTPO、トロンボポイエチン受容体アゴニスト(血小板減少性疾患)、AL−108、AL−208、神経成長因子アンタゴニスト(疼痛)、SLV−317、CGX−1007、INNO−105、経口テリパラチド(エリゲン)、GEM−OS1、AC−162352、PRX−302、LFn−p24融合ワクチン(Therapore)、EP−1043、S肺炎小児ワクチン、マラリアワクチン、髄膜炎菌(Neisseria meningitidis)B群ワクチン、新生児用B群連鎖球菌ワクチン、炭疽病ワクチン、HCVワクチン(gpE1+gpE2+MF−59)、中耳炎の治療、HCVワクチン(コア抗原+ISCOMATRIX)、hPTH(1−34)(経皮用、ViaDerm)、768974、SYN−101、PGN−0052、アビスクムミン、BIM−23190、結核ワクチン、マルチエピトープ・チロシナーゼペプチド、がんワクチン、エンカスチム、APC−8024、GI−5005、ACC−001、TTS−CD3、血管標的TNF(固形腫瘍)、デスモプレシン(バッカル制御放出型)、オネルセプト、及びTP−9201である。
Claims (26)
- 細胞培養物を増殖させ採取するための細胞培養装置であって、重ねた配置で複数の細胞培養チャンバーを備え、直径及び壁厚を有する少なくとも1つのバイオプロセスチューブを含み、前記少なくとも1つのバイオプロセスチューブが、熱可塑性エラストマーから構成される、細胞培養装置と、
細胞培養培地を保持するための中空エンクロージャーを画定する複数のバイオプロセスコンテナであって、各コンテナが、前記中空エンクロージャーと連通している細胞培養連結チューブを含み、連結チューブが、直径、壁厚を有し、前記バイオプロセスチューブの直径、壁厚、及び熱可塑性エラストマーと適合性を有する材料から構成される、複数のバイオプロセスコンテナと
を備え、
各バイオプロセスコンテナを前記細胞培養装置と選択的に流体連通させることが可能であるように、各バイオプロセスコンテナの前記細胞培養連結チューブが、前記細胞培養装置の前記バイオプロセスチューブに溶接されるように構成され、各細胞培養連結チューブ及び前記バイオプロセスチューブが、少なくとも2.25mmの壁厚を有する、
バイオプロセスシステム。 - 前記細胞培養連結チューブの1つが、前記細胞培養装置の前記バイオプロセスチューブと接続され、前記細胞培養連結チューブが、前記バイオプロセスチューブと溶接されて溶接構造を形成し、前記溶接構造が、前記細胞培養連結チューブが前記バイオプロセスチューブに取り付けられた場所を取り囲む漏出防止フランジを含む、請求項1に記載のバイオプロセスシステム。
- 前記漏出防止フランジが、約0.2mmを超える高さを有する、請求項2に記載のバイオプロセスシステム。
- 前記細胞培養装置を前記バイオプロセスコンテナの1つと流体連通させて、前記バイオプロセスチューブ内に開放接続を生み出さずに、前記細胞培養装置に物質を供給する、又はそれから物質を除去するために、前記バイオプロセスチューブと前記細胞培養連結チューブの1つとを同時に切断し、共に溶接するように構成されたバイオ溶接装置を更に備える、請求項1から3のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオ溶接装置内でチューブを切断及び溶接する間、前記バイオプロセスチューブ及び前記連結チューブ内の流体の流れを阻止するための流動停止デバイスを更に備える、請求項4に記載のバイオプロセスシステム。
- 前記熱可塑性エラストマーが、シリコーンポリマー、ポリ塩化ビニルポリマー、ポリプロピレンポリマー、ポリエチレンポリマー、又はポリエステルポリマーを含む、請求項1から5のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオプロセスチューブが、少なくとも2.75mm、例えば少なくとも3mm等の壁厚を有する、請求項1から6のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオプロセスチューブが、約2.75mm〜約3.75mmの壁厚を有する、請求項1から7のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオプロセスチューブが、約7.5mm〜約12.5mm、例えば約8.5mm〜約10.5mm等の内径を有する、請求項1から8のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオプロセスチューブ及び前記連結チューブが、同一の直径、壁厚を有し、同一の熱可塑性エラストマーから作製される、請求項1から9のいずれか一項に記載のバイオプロセスシステム。
- 少なくとも3つのバイオプロセスコンテナを含み、前記コンテナのうちの少なくとも1つが試薬を収納しており、前記コンテナのうちの少なくとも1つが、前記細胞培養装置から液体培地を受け入れるために空である、請求項1から10のいずれか一項に記載のバイオプロセスシステム。
- 前記バイオプロセスコンテナの前記中空エンクロージャーが、約0.5リットル〜約25リットルの容積を有する、請求項1から11のいずれか一項に記載のバイオプロセスシステム。
- 物質を細胞培養装置に送達する方法であって、
少なくとも1つのバイオプロセスチューブの端部部分を通る流体の流れを遮断するステップであって、前記バイオプロセスチューブが、細胞培養装置と接続され、且つ流体連通した状態にあり、前記細胞培養装置が、重ねた配置で複数の細胞培養チャンバーを含み、前記バイオプロセスチューブが、内径及び壁厚を有する熱的プラスチックエラストマーを含み、前記バイオプロセスチューブが、物質を前記細胞培養装置に送達し、それから取り除くように構成されている、ステップと、
バイオプロセスコンテナと連通している細胞培養連結チューブの端部部分を通る流体の流れを遮断し、前記バイオプロセスコンテナが細胞培養培地を収納する、ステップと、
前記バイオプロセスチューブの前記端部部分及び前記細胞培養連結チューブの前記端部部分を切断し、共に溶接するステップであって、前記バイオプロセスチューブ及び前記細胞培養連結チューブが、少なくとも2.25mmの壁厚を有する、ステップと、
前記バイオプロセスチューブ及び前記細胞培養連結チューブを通る流体の流動の遮断を解除するステップと、
前記細胞培養培地を、前記バイオプロセスコンテナから前記連結チューブ及び前記バイオプロセスチューブを通じて前記細胞培養装置に供給するステップと
を含む、
方法。 - 前記少なくとも1つのバイオプロセスチューブの前記端部部分を通る流体の流動を遮断するステップと、
前記細胞培養連結チューブの前記端部部分を通る流体の流動を遮断するステップと、
前記バイオプロセスチューブを通る流体の流動を遮断するステップと、
第2のバイオプロセスコンテナと連通している第2の細胞培養連結チューブの端部部分を通る流体の流動を遮断し、前記第2のバイオプロセスコンテナが細胞培養培地を収納する、ステップと、
前記バイオプロセスチューブと前記第2の細胞培養連結チューブの前記端部部分とを切断し、共に溶接するステップであって、切断及び溶接手順の間に前記バイオプロセスチューブの開放接続が決して形成されないような方式で、前記バイオプロセスチューブ及び前記第2の細胞培養連結チューブの前記端部部分が切断され、共に溶接される、ステップと、
前記バイオプロセスチューブ及び前記第2の細胞培養連結チューブを通る流体の流動の遮断を解除するステップと、
前記細胞培養培地を、前記第2のバイオプロセスコンテナから前記第2の細胞培養連結チューブ及び前記バイオプロセスチューブを通じて前記細胞培養装置に供給するステップと
を更に含む、
請求項13に記載の方法。 - 前記バイオプロセスチューブの前記端部部分及び前記細胞培養連結チューブの前記端部部分を切断し、共に溶接するステップを、換気されたエンクロージャー内で行わない、請求項13に記載の方法。
- 前記細胞培養培地が、前記細胞培養装置に接種するため、及び前記細胞培養装置内で細胞培養物を増殖させるための生存細胞を含む、請求項13に記載の方法。
- 前記バイオプロセスチューブの前記端部部分が、開放接続を生み出さずに切断され、前記細胞培養連結チューブの前記端部部分に溶接される、請求項13に記載の方法。
- 前記細胞培養培地が、前記細胞培養装置に接種するため、及び前記細胞培養装置内で細胞培養物を増殖させるための生存細胞を含み、前記第2のバイオプロセスコンテナに収納される前記細胞培養培地が、細胞栄養組成物を含む、請求項14に記載の方法。
- 前記第2のバイオプロセスコンテナに収納される前記細胞培養培地が、前記細胞培養装置から細胞培養物を脱離させ採取するためのタンパク質分解酵素を含む、請求項14に記載の方法。
- 前記第2の細胞培養連結チューブが、第1のYチューブと第2のYチューブに通じるY接続を含み、前記第1のYチューブが前記第2のバイオプロセスコンテナと接続され、前記第2のYチューブが第3のバイオプロセスコンテナと接続され、前記第2のバイオプロセスコンテナに収納される前記細胞培養培地が、前記細胞培養装置から細胞培養物を脱離させ採取するためのタンパク質分解酵素を含み、前記第3のバイオプロセスコンテナがクエンチ組成物を収納し、前記クエンチ組成物が、前記タンパク質分解酵素の後に前記細胞培養装置に供給される、請求項14に記載の方法。
- 細胞培養物を前記細胞培養装置から採取するために、前記タンパク質分解酵素及び前記クエンチ組成物が前記細胞培養装置に供給された後に、前記細胞培養装置の中身が、前記第2のバイオプロセスコンテナ又は前記第3のバイオプロセスコンテナに移される、請求項20に記載の方法。
- 前記バイオプロセスチューブの前記端部部分と前記細胞培養連結チューブの前記端部部分が溶接構造を形成し、前記溶接構造が、前記バイオプロセスチューブが前記細胞培養連結チューブに溶接されている場所を取り囲む漏出防止フランジを含み、前記フランジが約0.2mmを超える高さを有する、請求項13に記載の方法。
- 液体を保持するための内部容積を画定する、第1の端部と第2の反対側の端部を有する可撓性コンテナと、
前記可撓性コンテナの前記第1の端部に位置する複数のポートであって、各ポートが前記内部容積と流体連通しており、前記ポートの1つが、前記可撓性コンテナと細胞培養装置とを接続するように構成された細胞培養連結チューブと接続している、複数のポートと、
前記ポートのそれぞれと連通している前記可撓性コンテナの前記第1の端部に配置された流動ガイドデバイスであって、硬質材料から作製された単一構造を備え、前記複数のポートに対応する複数の間隔が置かれた通路を画定する、流動ガイドデバイスと、
を備える、
バイオプロセスコンテナ。 - 前記細胞培養連結チューブが、少なくとも2.25mmの壁厚を有する、請求項23に記載のバイオプロセスコンテナ。
- 前記細胞培養連結チューブが、少なくとも2.75mmの壁厚を有し、約7.5mm〜約12.5mmの内径を有する、請求項23に記載のバイオプロセスコンテナ。
- 前記複数の間隔が置かれた通路が、約6mm〜約12mmの直径を有する、請求項23から25のいずれか一項に記載のバイオプロセスコンテナ。
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JP2022191363A (ja) | 2022-12-27 |
CN110462017B (zh) | 2023-12-08 |
US11559811B2 (en) | 2023-01-24 |
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IL268433B2 (en) | 2024-03-01 |
KR102499475B1 (ko) | 2023-02-15 |
WO2018148346A1 (en) | 2018-08-16 |
JP7350142B2 (ja) | 2023-09-25 |
KR20190117000A (ko) | 2019-10-15 |
IL268433B1 (en) | 2023-11-01 |
IL268433A (en) | 2019-09-26 |
EP3565883A1 (en) | 2019-11-13 |
CN110462017A (zh) | 2019-11-15 |
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