JP2016178938A5 - - Google Patents
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- JP2016178938A5 JP2016178938A5 JP2016118316A JP2016118316A JP2016178938A5 JP 2016178938 A5 JP2016178938 A5 JP 2016178938A5 JP 2016118316 A JP2016118316 A JP 2016118316A JP 2016118316 A JP2016118316 A JP 2016118316A JP 2016178938 A5 JP2016178938 A5 JP 2016178938A5
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Claims (34)
- 水溶性ポリマーとグリコシル化ペプチドまたは非−グリコシル化ペプチドとの共有結合物を形成する方法であって、
該水溶性ポリマーは、天然に存在する糖ではなく、かつ該ペプチドと該水溶性ポリマーの間に挿入されそして該ペプチドと該水溶性ポリマーの両方を共有結合により連結する、インタクトなグリコシル連結基を介して、該水溶性ポリマーが、該ペプチドに結合しているものであり、該インタクトなグリコシル連結基は該ペプチドに該水溶性ポリマーを結合する個々のサッカリドモノマーが酸化されていないグリコシル部分であり、
該ペプチドを、該水溶性ポリマーに共有結合しているヌクレオチド糖および該ヌクレオチド糖を基質とするグリコシルトランスフェラーゼを含む混合物と、該共有結合物を形成するために十分な条件下で接触させる工程を含む、方法。 - 前記グリコシル連結基が、前記ペプチドに共有結合したグリコシル残基に共有結合する、請求項1に記載の方法。
- 前記グリコシル連結基が前記ペプチドのアミノ酸残基に共有結合する、請求項1に記載の方法。
- 前記グリコシルトランスフェラーゼが、シアリルトランスフェラーゼ、ガラクトシルトランスフェラーゼ、グルコシルトランスフェラーゼ、GalNAcトランスフェラーゼ、GlcNAcトランスフェラーゼ、フコシルトランスフェラーゼおよびマンノシルトランスフェラーゼからなる群から選択される、請求項1に記載の方法。
- 前記グルコシルトランスフェラーゼが組換え的に生産される、請求項1に記載の方法。
- 前記グルコシルトランスフェラーゼが組換え原核酵素である、請求項5に記載の方法。
- 前記グルコシルトランスフェラーゼが組換え真核酵素である、請求項5に記載の方法。
- 前記ヌクレオチド糖がUDP−グリコシド、CMP−グリコシドおよびGDP−グリコシドよりなる群から選択される、請求項1に記載の方法。
- 前記ヌクレオチド糖が、UDP−ガラクトース、UDP−ガラクトサミン、UDP−グルコース、UDP−グルコサミン、UDP−N−アセチルガラクトサミン、UDP−N−アセチルグルコサミン、GDP−マンノース、GDP−フコース、CMP−シアル酸、CMP−NeuAcよりなる群から選択される、請求項8に記載の方法。
- 前記ペプチドが治療薬である、請求項1に記載の方法。
- 前記グリコシル化ペプチドが前記接触前に部分的に脱グリコシル化されている、請求項1に記載の方法。
- 前記インタクトなグリコシル連結基がシアル酸残基である、請求項1に記載の方法。
- 前記方法が無細胞環境下で行われる、請求項1に記載の方法。
- 前記共有結合物を、さらに単離する工程を含む、請求項1に記載の方法。
- 前記共有結合物が膜濾過により単離されている、請求項14に記載の方法。
- 前記ペプチドがインターフェロン−アルファ、インターフェロン−ベータ、第VIIa因子、第IX因子、濾胞刺激ホルモン、エリトロポエチン、顆粒球マクロファージコロニー刺激因子、インターフェロン−ガンマ、アルファ−1−プロテアーゼインヒビター、ベータ−グルコシダーゼ、組織プラスミノーゲンアクチベータータンパク質、インターロイキン−2、第VIII因子、キメラ腫瘍壊死因子受容体、ウロキナーゼ、キメラ抗−糖タンパク質IIb/IIIa抗体、キメラ抗−HER2抗体、キメラ抗−呼吸合胞体ウイルス抗体、キメラ抗−CD20抗体、DNase、キメラ抗−腫瘍壊死因子抗体、ヒトインスリン、B型肝炎sAgおよびヒト成長ホルモンよりなる群から選択される、請求項1に記載の方法。
- 請求項16に記載の方法で形成されるペプチド結合物。
- ペプチドと該ペプチドの特性を改変する修飾基を含む共有結合物であって、該修飾基がインタクトなグリコシル連結基を介して該ペプチドの予め選択されたグリコシルまたはアミノ酸残基において該ペプチドに共有結合し、該修飾基およびインタクトなグリコシル連結基前駆体が、共有結合した単位としてグリコシルトランスフェラーゼの作用を介して該ペプチドに結合しており、該グリコシルトランスフェラーゼは該前駆体を該インタクトなグリコシル連結基に転換し、これにより該結合物を形成し、該インタクトなグリコシル連結基は該ペプチドに該修飾基を結合する個々のサッカリドモノマーが酸化されていないグリコシル部分である、共有結合物。
- 請求項18に記載の共有結合物および製薬学的に許容され得る希釈剤を含む製薬学的製剤。
- ペプチドと水溶性ポリマーとの共有結合物であって、
前記水溶性ポリマーが天然に存在する糖ではなく、かつ、前記水溶性ポリマーがインタクトなグリコシル連結基を介して前記ペプチドに結合している、共有結合物。 - 前記水溶性ポリマーがポリ(エーテル)である、請求項20に記載の共有結合物。
- 前記ポリ(エーテル)がポリ(アルキレンオキシド)である、請求項21に記載の共有結合物。
- 前記ポリ(アルキレンオキシド)がポリ(エチレングリコール)である、請求項22に記載の共有結合物。
- 前記ポリ(エチレングリコール)が直鎖ポリ(エチレングリコール)および分岐ポリ(エチレングリコール)から選択されるメンバーである、請求項23に記載の共有結合物。
- 前記ポリ(エチレングリコール)が約1〜約5,000の重合度を有する、請求項23又は24に記載の共有結合物。
- 前記ポリ(エチレングリコール)が約1〜約1,000の重合度を有する、請求項25に記載の共有結合物。
- 前記インタクトなグリコシル連結基が炭水化物部分、アミノ酸部分、及びそれらの組み合わせから選択されるメンバーに結合している、請求項20〜26のいずれか一項に記載の共有結合物。
- 前記インタクトなグリコシル連結基がO−またはN−結合グリカンおよびそれらの組み合わせから選択されるメンバーである炭水化物部分に結合している、請求項27に記載の共有結合物。
- 前記インタクトなグリコシル連結基が前記アミノ酸部分のヒドロキシルもしくはアミノ基またはそれらの組み合わせに結合している、請求項27に記載の共有結合物。
- 前記インタクトなグリコシル連結基がシアル酸、ガラクトース、N−アセチルグルコサミンまたはN−アセチルガラクトサミン残基を含む、請求項27に記載の共有結合物。
- 前記水溶性ポリマーがシアル酸残基に、前記シアル酸残基の5位及び9位から選択される位置で結合している、請求項20または21に記載の共有結合物。
- 前記ペプチドが治療薬である、請求項20〜31のいずれか一項に記載の共有結合物。
- 前記ペプチドがインターフェロン−アルファ、インターフェロン−ベータ、第VIIa因子、第IX因子、濾胞刺激ホルモン、エリトロポエチン、顆粒球マクロファージコロニー刺激因子、インターフェロン−ガンマ、アルファ−1−プロテアーゼインヒビター、ベータ−グルコシダーゼ、組織プラスミノーゲンアクチベータータンパク質、インターロイキン−2、第VIII因子、キメラ腫瘍壊死因子受容体、ウロキナーゼ、キメラ抗−糖タンパク質IIb/IIIa抗体、キメラ抗−HER2抗体、キメラ抗−呼吸合胞体ウイルス抗体、キメラ抗−CD20抗体、DNase、キメラ抗−腫瘍壊死因子抗体、ヒトインスリン、B型肝炎sAgおよびヒト成長ホルモンよりなる群から選択される、請求項20〜32のいずれか一項に記載の共有結合物。
- 請求項20〜33のいずれか一項に記載の共有結合物および製薬学的に許容され得る希釈剤を含む医薬組成物。
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