JP2013501522A5 - - Google Patents
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- JP2013501522A5 JP2013501522A5 JP2012524763A JP2012524763A JP2013501522A5 JP 2013501522 A5 JP2013501522 A5 JP 2013501522A5 JP 2012524763 A JP2012524763 A JP 2012524763A JP 2012524763 A JP2012524763 A JP 2012524763A JP 2013501522 A5 JP2013501522 A5 JP 2013501522A5
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- Prior art keywords
- antibody
- factor
- human
- polypeptide
- protein
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Claims (25)
- ポリペプチドを、該ポリペプチドを発現している哺乳動物宿主細胞において産生する方法において、アスパラギン含有のグルタミンフリー産生培養培地における培養の産生期で哺乳動物宿主細胞を培養することを含んでなり、アスパラギンが7.5mMから15mMの範囲の濃度で添加される方法。
- アスパラギンが7.5mMから10mMの範囲の濃度で添加される請求項1に記載の方法。
- 前記組換え宿主細胞が真核生物宿主細胞である請求項1に記載の方法。
- 前記哺乳動物宿主細胞がチャイニーズハムスター卵巣(CHO)細胞である請求項3に記載の方法。
- 哺乳動物宿主細胞がdhfr−CHO細胞である請求項4に記載の方法。
- 産生培地が無血清である請求項1に記載の方法。
- 産生培養培地が
1)エネルギー源;
2)必須アミノ酸;
3)ビタミン;
4)遊離脂肪酸;及び
5)微量元素
から成る群から選択される一又は複数の成分を含有する請求項1に記載の方法。 - 産生培養培地が
1)ホルモン及び他の増殖因子;
2)塩及びバッファー;及び
3)ヌクレオシド
から成る群から選択される一又は複数の成分を更に含有する請求項7に記載の方法。 - 産生期が回分又は流加培養期である請求項1に記載の方法。
- 前記ポリペプチドを単離する工程を更に含んでなる請求項1に記載の方法。
- 細胞生存度、培養寿命、比生産性及び単離後の最終組換えタンパク質力価の一又は複数を決定することを更に含んでなる請求項10に記載の方法。
- 細胞生存度、培養寿命、比生産性及び最終組換えタンパク質力価の少なくとも一つが、同じ組成のグルタミン含有産生培地で産生される同じポリペプチドと比較して増加される請求項11に記載の方法。
- ポリペプチドが哺乳動物糖タンパク質である請求項1に記載の方法。
- ポリペプチドが抗体、抗体断片及びイムノアドヘシンからなる群から選択される請求項1に記載の方法。
- 前記抗体断片が、Fab、Fab′、F(ab′)2、scFv、(scFv)2、dAb、相補性決定領域(CDR)断片、線状抗体、単鎖抗体分子、ミニボディ、ダイアボディ、抗体断片から形成された多重特異性抗体から成る群から選択される請求項14に記載の方法。
- 抗体又は抗体断片が、キメラ、ヒト化又はヒトである請求項14に記載の方法。
- 前記抗体又は抗体断片が、治療用抗体又はそれらの生物学的に機能的な断片である請求項14に記載の方法。
- 前記治療用抗体が、抗HER2抗体 抗CD20抗体;抗IL-8抗体;抗VEGF抗体;抗CD40抗体、抗CD11a抗体;抗CD18抗体;抗免疫IgE抗体;抗Apo-2受容体抗体;抗組織因子(TF)抗体;抗ヒトα4β7インテグリン抗体;抗EGFR抗体;抗CD3抗体;抗CD25抗体;抗CD4抗体;抗CD52抗体;抗Fc受容体抗体;抗癌胎児性抗原(CEA)抗体;胸部上皮細胞に対する抗体;結腸癌細胞に結合する抗体;抗CD38抗体;抗CD33抗体;抗CD22抗体;抗EpCAM抗体;抗GpIIb/IIIa抗体;抗RSV抗体;抗CMV抗体;抗HIV抗体;抗肝炎抗体;抗CA125抗体;抗αvβ3抗体;抗ヒト腎細胞癌抗体;抗ヒト17-1A抗体;抗ヒト直腸結腸腫瘍抗体;GD3ガングリオシドに対する抗ヒト黒色腫抗体R24;抗ヒト扁平上皮癌;及び抗ヒト白血球抗原(HLA)抗体及び抗HLA DR抗体からなる群から選択される請求項17に記載の方法。
- 前記治療用抗体が、HER受容体、VEGF、IgE、CD20、CD11a、CD40、BR3又はDR5に結合する抗体である請求項17に記載の方法。
- DR5に結合する前記治療用抗体が、Apomabs1.1、2.1、3.1、4.1、5.1、5.2、5.3、6.1、6.2、6.3、7.1、7.2、7.3,8.1、8.3、9.1、1.2、2.2、3.2、4.2、5.2、6.2、7.2、8.2、9.2、1.3、2.2、3.3、4.3、5.3、6.3、7.3、8.3、9.3、及び25.3から成る群から選択される請求項19に記載の方法。
- 前記治療用抗体が抗BR3抗体である請求項19に記載の方法。
- 前記ポリペプチドが治療用ポリペプチドである請求項1に記載の方法。
- 前記治療用ポリペプチドが、ヒト成長ホルモン及びウシ成長ホルモンを含む成長ホルモン;成長ホルモン放出因子;副甲状腺ホルモン;甲状腺刺激ホルモン;リポタンパク質;アルファ-1-アンチトリプシン;インスリンA-鎖;インスリンB鎖;プロインスリン;卵胞刺激ホルモン;カルシトニン;黄体形成ホルモン;グルカゴン;凝固因子、例えば第VIIIC因子、第IX因子、組織因子及びヴォン・ヴィレブランド因子;抗凝固因子、例えばプロテインC;心房ナトリウム利尿因子;肺表面活性物質;プラスミノーゲン活性化因子、例えばウロキナーゼ又はヒト尿又は組織型プラスミノーゲンアクチベーター(t-PA);ボンベシン;トロンビン;造血成長因子;腫瘍壊死因子-α及び-β;エンケファリナーゼ;ランテス(RANTES(regulated on activation normally T-cell expressed and secreted));ヒトマクロファージ炎症性タンパク質(MIP-1-α);血清アルブミン、例えばヒト血清アルブミン;ミュラー管抑制因子;リラキシンA-鎖;リラキシンB-鎖;プロ・リラキシン;マウス・ゴナドトロピン関連ペプチド;微生物タンパク、例えばβ‐ラクタマーゼ;デオキシリボヌクレアーゼ;IgE;細胞傷害性Tリンパ球関連抗原(CTLA)、例えばCTLA-4;インヒビン;アクチビン;血管内皮成長因子(VEGF);ホルモン又は増殖因子の受容体;プロテインA又はD;リウマトイド因子;神経栄養因子、例えば骨由来神経栄養因子(BDNF)、ニューロトロフィン-3、-4、-5又は-6(NT-3、NT-4、NT-5、又はNT-6)、又は神経成長因子、例えばNGF-β;血小板由来増殖因子(PDGF);線維芽細胞増殖因子、例えばaFGF及びbFGF;上皮成長因子(EGF);トランスフォーミング増殖因子(TGF)、例えばTGFアルファ及びTGFベータ、TGF-β1、TGF-β2、TGF-β3、TGF-β4又はTGF-β5を含む;インスリン様増殖因子-I及び-II(IGF-I及びIGFII);des(1-3)-IGF-I(脳IGF-I)、インスリン様増殖因子結合タンパク質;CDタンパク質、例えばCD3、CD4、CD8、CD19、CD20、CD34及びCD40;エリスロポエチン;骨誘導因子;イムノトキシン;骨形成タンパク質(BMP);インターフェロン、例えばインターフェロン-α、-β、及び、-γ;コロニー刺激因子(CSF)、例えばM-CSF、GM-CSF及びG-CSF;インターロイキン(IL)、例えばIL-1からIL-10;スーパーオキシドジスムターゼ;T細胞受容体;表層膜タンパク質;崩壊促進因子;ウィルス抗原、例えばAIDSエンベロープの一部;輸送タンパク質;ホーミング受容体;アドレシン;調節タンパク質;インテグリン、例えばCD11a、CD11b、CD11c、CD18、ICAM、VLA-4及びVCAM;腫瘍関連抗原、例えばHER2、HER3又はHER4受容体;及び前記ポリペプチドの断片から成る群から選択される請求項22に記載の方法。
- 産生期におけるポリペプチドの産生のための、アスパラギンを含有する使用準備済のグルタミンフリー細胞培養培地であって、アスパラギンが7.5mM〜15mMの範囲の濃度である培養培地。
- 前記イムノアドヘシンがBR3-Fcイムノアドヘシンである請求項14に記載の方法。
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