JP2022097744A - 緩衝剤溶液を提供するための方法及びシステム - Google Patents
緩衝剤溶液を提供するための方法及びシステム Download PDFInfo
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Abstract
Description
別途規定しない限り、本明細書で使用される全ての技術用語及び科学用語は、本開示が属する技術分野の当業者によって一般に理解されるのと同じ意味を有する。本明細書に記載される方法及び材料と類似又は均等な任意の方法及び材料が、本開示の実施又は試験において使用され得るが、好ましい材料及び方法は、本明細書に記載される。本開示の記載及び請求項において、以下の用語は、ある規定が提供される場合、どのように用語が規定されるかに応じて使用される。
処理溶液は、更に精製し、或いは溶液の純度を評価するために、クロマトグラフ及び/又は分光学的方法と共に使用することができる。ここで説明される方法に使用するのに適した1次元(1D:1-dimensional)クロマトグラフィーの方法は当業者に知られており、例えばアフィニティクロマトグラフィー、ゲル濾過クロマトグラフィー、イオン交換クロマトグラフィー、逆位相クロマトグラフィー、疎水性相互作用クロマトグラフィーを含む。いくつかの実施例では、1次元クロマトグラフィー方法はHPLC逆位相クロマトグラフィーである。クロマトグラフィーは、高性能液体クロマトグラフィー(HPLC:high performance liquid chromatography)、ガスクロマトグラフィー(GC:gas chromatography)、キャピラリー電気泳動、イオン移動度を含むことができる。同じく、例えばProcess Scale Purification of Antibodies、Uwe Gottschalk 2011 John Wiley & Sons ISBN: 1118210743、Antibodies Vol 1 Production and Purification、G. Subramanian 2013 Springer Science & Business Media、Basic Methods in Antibody Production and Characterization、Gary C. Howard 2000 CRC Pressを参照されたい。
本明細書において説明されている方法に使用するために適した質量分析法方法は当業者に知られており、例えばエレクトロスプレー電離MS、マトリックス支援レーザ脱着/電離MS、飛行時間MS、フーリエ変換イオンサイクロトロン共鳴MS、四重極飛行時間MS、線形四重極、四重極イオントラップMS、オービトラップ、円筒状イオントラップ、3次元イオントラップ、四重極質量フィルタ、タンデム質量分析法を含む。いくつかの実施例では、質量分析法はタンデム質量分析法である。同じく、例えばProtein Mass Spectrometry、Julian Whitelegge、2008年、Elsevier、Protein Sequencing and Identification Using Tandem Mass Spectrometry、Michael Kinter、2005年、John Wiley & Sons、Characterization of Protein Therapeutics using Mass Spectrometry、Guodong Chen、2014年、Springer Science & Business Mediaを参照されたい。
本明細書において説明されている方法は、糖タンパク質調製物を製造する際に、予め選択済み1つ又は複数のグリカン特性を得ることができるよう、糖タンパク質調製物のための1つ又は複数の製造パラメータを決定するステップ及び/又は選択するステップを含む。グリコシル化に対する様々な製造パラメータの効果に関する情報を使用することにより、所望のグリカン特性と積極的に相関する糖タンパク質調製物の製造に先立って製造パラメータを選択することができる。本明細書において使用されているように、製造パラメータは、製造プロセスにおけるパラメータ又は要素である。選択することができる製造パラメータは、例えば、糖タンパク質調製物を製造するために使用される細胞又は細胞系、培養培地、培養プロセス又はバイオリアクタ変数(例えばバッチ、フェッド-バッチ又は灌流)、精製プロセス及び糖タンパク質調製物の調合を含む。
本明細書において説明されている方法は、所望の1つ又は複数のグリカン特性に対する積極的な相関を有する培地成分を決定するステップ及び/又は選択するステップ、及び/又はその濃度を決定するステップ及び/又は選択するステップを含むことができる。培地成分は、培地の変化が存在すると、培養状態に応じて糖タンパク質製造の進行中に加えることができ、或いは糖タンパク質の製造が進行している間、管理することができる。培地成分は、培養のために直接加えられる成分、並びに細胞培養の副産物である成分を含む。
本明細書においては、製品を製造することができる細胞又は細胞系を識別し、選択し、或いは作るための方法が提供される。本開示によって包含される製品は、それらに限定されないが、例えば細胞中で発現されることによって製造することができる、分子、核酸、ポリペプチド(例えば組換えポリペプチド、例えば抗体、二重特異性抗体、多重特異性抗体)又はそれらの混成を含む。いくつかの実施例では、細胞は、製品を製造するために工作又は修正される。そのような修飾には、産物の産生を制御する又はもたらす分子を導入することが含まれる。例えば、細胞は、ポリペプチド、例えば、組換えポリペプチドをコードする外来性核酸を導入することによって修飾され、細胞は、ポリペプチド、例えば、組換えポリペプチドの産生、例えば、発現及び分泌に適切な条件下で培養される。
実施例では、細胞は、哺乳動物細胞である。他の実施例では、細胞は、哺乳動物細胞以外の細胞である。一実施例では、細胞は、マウス、ラット、チャイニーズハムスター、シリアンハムスター、サル、類人猿(ape)、イヌ、ウマ、フェレット、又はネコである。実施例では、細胞は、哺乳動物細胞、例えば、ヒト細胞又はげっ歯類細胞、例えば、ハムスター細胞、マウス細胞、又はラット細胞である。別の実施例では、細胞は、カモ、オウム、魚、昆虫、植物、真菌、又は酵母からの細胞である。一実施例では、細胞は、古細菌である。一実施例では、細胞は、アクチノバクテリア、例えば、結核菌の種である。
哺乳動物及び微生物選択系の両方における当技術分野における現在の最新技術は、RNAへのDNAの転写のレベルで選択圧を適用することである。対象とする遺伝子は、対象とする遺伝子の高発現をもたらす可能性が高い、選択マーカーを高レベルで発現させる選択マーカーに厳密に連結される。高レベルで選択マーカーを発現する細胞は、生存及び増殖することができ、発現しないものは、生存及び増殖する可能性が低く、例えば、アポトーシス(apoptose)及び/又は死亡する。このような方法で、細胞の集団は、選択マーカーを発現する細胞に関して富化され得ることから、対象とする遺伝子が高レベルであることが含意され得る。この方法は、直接的なタンパク質の発現について非常に成功することが証明されている。実施例では、本明細書に記載されるプロセスは、実質的に純粋なタンパク質産物を提供する。本明細書で使用するように、「実質的に純粋」は、実質的に発熱性物質非含有、実質的に核酸非含有、及び/又は実質的にポリメラーゼ、リボソームタンパク質、及びシャペロンタンパク質などの宿主細胞からの内因性細胞タンパク質酵素及び成分非含有であることを意味する。実質的に純粋なタンパク質産物は、例えば、25%、20%、15%、10%、9%、8%、7%、6%、5%、4%、3%、2%、又は1%未満の夾雑内因性タンパク質、核酸、又は宿主細胞からの他の高分子を含有する。
Tat Toxoid、YSPSL、CHS-13340、PTH(1-34)リポソームクリーム(Novasome)、Ostabolin-C、PTHアナログ(局所型、乾癬)、MBRI-93.02、MTB72Fワクチン(結核)、MVA-Ag85Aワクチン(結核)、FARA04、BA-210、組換え疫病FIVワクチン、AG-702、OxSODrol、rBetV1、Der-p1/Der-p2/Der-p7アレルゲン標的化ワクチン(イエダニアレルギー)、PR1ペプチド抗原(白血病)、突然変異体rasワクチン、HPV-16 E7リポペプチドワクチン、ラビリンチンワクチン(腺癌)、CMLワクチン、WT1ペプチドワクチン(がん)、IDD-5、CDX-110、Pentrys、Norelin、CytoFab、P-9808、VT-111、イクロカプチド、テルベルミン(皮膚科用、糖尿病性足部潰瘍)、ルピントリビル、レティキュロース、rGRF、HA、アルファ-ガラクトシダーゼA、ACE-011、ALTU-140、CGX-1160、アンジオテンシン治療用ワクチン、D-4F、ETC-642、APP-018、rhMBL、SCV-07(経口薬、結核)、DRF-7295、ABT-828、ErbB2特異的免疫毒素(抗がん剤)、DT3SSIL-3、TST-10088、PRO-1762、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、トラスニズマブ-DM1、アンタゴニストG、IL-12(組換え)、PM-02734、IMP-321、rhIGF-BP3、BLX-883、CUV-1647(局所型)、L-19をベースとする放射線免疫治療薬(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(パルス抗原治療薬)、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(注射剤)、ACP-HIP、SUN-11031、ペプチドYY[3-36](肥満、鼻内型)、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(経鼻型、骨粗鬆症)、F-18-CCR1、AT-1001(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(GlycoPEGylated)エリスロポエチン、EPO-Fc、CNTO-528、AMG-114、JR-013、第XIII因子、アミノカンディン、PN-951、716155、SUN-E7001、TH-0318、BAY-73-7977、テベレリクス(即放型)、EP-51216、hGH(制御放出型、Biosphere)、OGP-I、シフュービルタイド、TV-4710、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、elafin、NMK-150、ALTU-139、EN-122004、rhTPO、トロンボポエチン受容体アゴニスト(血小板減少症)、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、経口型テリパラチド(エリゲン)、GEM-OS1、AC-162352、PRX-302、LFn-p24融合ワクチン(Therapore)、EP-1043、肺炎連鎖球菌小児ワクチン、マラリアワクチン、B群髄膜炎菌ワクチン、新生児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)、中耳炎治療薬、HCVワクチン(コア抗原+ISCOMATRIX)、hPTH(1-34)(経皮型、ViaDerm)、768974、SYN-101、PGN-0052、アビスクミン、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、血管標的化TNF(固形腫瘍)、デスモプレシン(口腔制御放出型)、オネルセプト、及びTP-9201である。
本開示による生物製剤を処理するための処理溶液成分
表6~9は、バイオリアクタ中で調製される1つの生物製剤のための本開示による処理溶液の成分、成分濃度及び緩衝剤要件を列挙する。表7~9における緩衝剤A~Lは、表6において同定される緩衝剤A~Lに対応する。
Claims (20)
- 処理溶液を送達するためのシステムであって、
第1のサイトで製造された濃縮処理溶液を含むバイオプロセス容器と、
前記第1のサイトとは異なる第2のサイトに少なくとも1つの処理ユニットを有する処理エリアと、
前記バイオプロセス容器を前記少なくとも1つの処理ユニットに接続するパイプであって、前記バイオプロセス容器から前記少なくとも1つの処理ユニットへの前記濃縮処理溶液の流れを許容し、それにより前記濃縮処理溶液と、前記少なくとも1つの処理ユニット内で製造された生体高分子含有溶液とを結合するバルブを有するパイプと
を備え、前記処理溶液が緩衝剤及び培地のうちの少なくとも1つである、システム。 - 前記少なくとも1つの処理ユニットに接続されたコントローラを更に備え、
前記濃縮処理溶液が、前記処理溶液が必要であることが前記コントローラによって決定され、前記決定が前記第2のサイトから前記第1のサイトへ通信されると、前記決定に基づいて提供される、請求項1に記載のシステム。 - 前記システムが、前記生体高分子含有溶液との結合に先立って前記濃縮処理溶液を希釈するように構成される、請求項1又は請求項2に記載のシステム。
- 前記処理溶液が、トリス、トリス塩基、トリシン、HEPES、MOPS、PIPES、TAPS、ビシン、BES、TES、カコジラート、MES、アセテート、MKP、ADA、ACES、グリシンアミド、アセトアミドグリシン、酢酸、クエン酸、グリシン、グリシングリシナート、リン酸ナトリウム、エタノール、塩酸、水酸化ナトリウム、塩化グアニジニウム、塩酸グアニジン、塩化ナトリウム及びこれらの任意の組合せのうちの1つである、請求項1から3までのいずれかに記載のシステム。
- 前記バイオプロセス容器が、前記処理溶液を接触させるための内部層、及び前記内部層を支持するように構成された外部層を含む、請求項1から4までのいずれかに記載のシステム。
- 前記処理溶液のバイオバーデンを決定するように構成されたコントローラを更に備える、請求項1及び3から5までのいずれかに記載のシステム。
- 希釈液サプライを備え、
前記バイオプロセス容器からの前記濃縮処理溶液、及び前記希釈液サプライからの水及び緩衝剤のうちの少なくとも1つがインライン処理溶液希釈システムの入口に加えられ、それにより希釈された処理溶液が得られる、請求項1から6までのいずれかに記載のシステム。 - 処理溶液を送達するための方法であって、
バイオプロセス容器の中に濃縮処理溶液を提供するステップであって、第1のサイトで前記濃縮処理溶液が製造される、ステップと、
前記濃縮処理溶液と、前記第1のサイトとは異なる第2のサイトのバイオリアクタ内で製造された生体高分子含有溶液とを結合するステップと
を含み、前記処理溶液が緩衝剤及び培地のうちの少なくとも1つである、方法。 - 前記濃縮処理溶液が、前記濃縮処理溶液が必要であることが決定され、且つ、前記決定が前記第2のサイトから前記第1のサイトへ通信されることに基づいて提供される、請求項8に記載の方法。
- 前記生体高分子含有溶液との結合に先立って前記濃縮処理溶液を希釈するステップを更に含む、請求項8又は請求項9に記載の方法。
- 前記処理溶液が、トリス、トリス塩基、トリシン、HEPES、MOPS、PIPES、TAPS、ビシン、BES、TES、カコジラート、MES、アセテート、MKP、ADA、ACES、グリシンアミド、アセトアミドグリシン、酢酸、クエン酸、グリシン、グリシングリシナート、リン酸ナトリウム、エタノール、塩酸、水酸化ナトリウム、塩化グアニジニウム、塩酸グアニジン、塩化ナトリウム及びこれらの任意の組合せのうちの1つである、請求項8から10までのいずれかに記載の方法。
- 前記バイオプロセス容器が、産物接触のための内部層、及び前記内部層を支持するように構成された外部層を備える、請求項8から11までのいずれかに記載の方法。
- 前記処理溶液のバイオバーデンを決定するステップを更に含む、請求項8から12までのいずれかに記載の方法。
- 前記処理溶液を含む前記バイオプロセス容器を前記第1のサイトから前記第2のサイトへ輸送するステップを更に含む、請求項8から13までのいずれかに記載の方法。
- 薬剤製造施設であって、
濃縮処理溶液を含むように構成された少なくとも1つのバイオプロセス容器を受け取ることができる緩衝剤貯蔵エリアと、
少なくとも1つの処理ユニットを有する処理エリアと、
前記緩衝剤貯蔵エリアを前記処理エリアから分離する壁と、
前記緩衝剤貯蔵エリア内に第1の端部を有し、また、前記処理エリア内に第2の端部を有する少なくとも1つのパイプであって、前記第1の端部が、前記少なくとも1つのバイオプロセス容器のうちの少なくとも1つのバイオプロセス容器に接続するように構成され、また、前記第2の端部が、前記少なくとも1つの処理ユニットのうちの少なくとも1つの処理ユニットに接続するように構成されるパイプと
を備える薬剤製造施設。 - 前記少なくとも1つのパイプがバルブを有する、請求項15に記載の薬剤製造施設。
- 前記少なくとも1つのバイオプロセス容器が、前記処理溶液を接触させるための内部層、及び前記内部層を支持するように構成された外部層を含む、請求項15又は請求項16に記載の薬剤製造施設。
- 前記緩衝剤貯蔵エリア内のプラットホームを更に備え、前記プラットホームが、前記少なくとも1つのバイオプロセス容器を支持するように構成され、
前記少なくとも1つのバイオプロセス容器が複数のバイオプロセス容器を含み、
前記プラットホームが、前記複数のバイオプロセス容器のうちの少なくとも1つのバイオプロセス容器を支持するように構成された第1のレベル、及び前記複数のバイオプロセス容器のうちの少なくとも1つのバイオプロセス容器を支持するように構成された第2のレベルを有し、
前記プラットホームが、ユーザによる、フォークリフトを使用した前記プラットホーム上への前記複数のバイオプロセス容器のうちの1つのバイオプロセス容器の据付けを許容するように構成され、また、前記プラットホームが、ユーザによる、前記フォークリフトを使用した前記プラットホームからのそれぞれの前記バイオプロセス容器の除去を許容するように構成される、請求項15から17までのいずれかに記載の薬剤製造施設。 - 前記プラットホームに沿って間隔を隔てた複数の入口を更に備え、個々の入口が前記少なくとも1つのパイプに接続され、また、個々の入口が、前記複数のバイオプロセス容器のうちの1つのバイオプロセス容器の出口に接続されるように構成される、請求項18に記載の薬剤製造施設。
- 前記処理エリアがクリーンルーム環境として構成される、請求項15から19までのいずれかに記載の薬剤製造施設。
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