JP6670740B2 - 注入器および組み立て法 - Google Patents
注入器および組み立て法 Download PDFInfo
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- JP6670740B2 JP6670740B2 JP2016504292A JP2016504292A JP6670740B2 JP 6670740 B2 JP6670740 B2 JP 6670740B2 JP 2016504292 A JP2016504292 A JP 2016504292A JP 2016504292 A JP2016504292 A JP 2016504292A JP 6670740 B2 JP6670740 B2 JP 6670740B2
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Landscapes
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Description
容器は充填され、ストッパおよび流体システムが取り付けられ、次いでブロック1006で、Aクラスのクリーンルームとして作動されるスペース内で、おそらくは異なるやり方でCクラスのクリーンルームとして作動されるスペース内の隔離器内で、容器は開放タブ内に戻される。この時点から2つの代替的な進路または枝路が可能である。
(i)米国公開第2006/0040358号明細書(2006年2月23日発行)、第2005/0008642号明細書(2005年1月13日発行)、第2004/0228859号明細書(2004年11月18日発行)において、以下に限定されないが例えば、それらの明細書に記載された通りの抗体1A(DSMZ寄託番号DSM ACC2586)、抗体8(DSMZ寄託番号DSM ACC2589)、抗体23(DSMZ寄託番号DSM ACC2588)、および抗体18を含む明細書。
(ii)PCT国際公開第06/138729号パンフレット(2006年12月28日発行)と、国際公開第05/016970号パンフレット(2005年2月24日発行)と、Lu他による2004年のJ Biol Chem.279:2856〜65とにおいて、以下に限定されないが、それらの明細書に記載された通りの抗体2F8、A12、およびIMC−12を含むもの。
(iii)PCT国際公開第07/012614号パンフレット(2007年2月1日発行)、国際公開第07/000328号パンフレット(2007年1月4日発行)、国際公開第06/013472号パンフレット(2006年2月9日発行)、国際公開第05/058967号パンフレット(2005年6月30日発行)、および国際公開第03/059951号パンフレット(2003年7月24日発行)
(iv)米国公開第2005/0084906号明細書(2005年4月21日発行)において、以下に限定されないが、その明細書に記載された通りの抗体7C10、キメラ抗体C7C10、抗体h7C10、抗体7H2M、キメラ抗体*7C10、抗体GM607、ヒト化抗体7C10バージョン1、ヒト化抗体7C10バージョン2、ヒト化抗体7C10バージョン3、および抗体7H2HMを含むもの。
(v)米国公開第2005/0249728号明細書(2005年11月10日発行)、第2005/0186203号明細書(2005年8月25日発行)、第2004/0265307号明細書(2004年12月30日発行)、および第2003/0235582号明細書(2003年12月25日発行)、およびMaloney他による2003年のCancer Res.63:5073〜83とにおいて、以下に限定されないが、それらに記載された通りの抗体EM164、表面再建EM164、ヒト化EM164、huEM164v1.0、huEM164v1.1、huEM164v1.2、およびhuEM164v1.3を含むもの。
(vi)米国特許第7,037,498号明細書(2006年5月2日発行)、米国公開第2005/0244408号明細書(2005年11月30日発行)、第2004/0086503号明細書(2004年5月6日発行)、およびCohen他による2005年のClinical Cancer Res.11:2063〜73、例えば抗体CP‐751、871において、以下に限定されないが、それらに記載された通りの、ATCC受入番号PTA‐2792、PTA‐2788、PTA‐2790、PTA‐2791、PTA‐2789、PTA‐2793を有するハイブリドーマによって生産される抗体それぞれと、抗体2.12.1、2.13.2、2.14.3、3.1.1、4.9.2、および4.17.3とを含むもの。
(vii)米国公開第2005/0136063号明細書(2005年6月23発行)および第2004/0018191号明細書(2004年1月29日発行)において、以下に限定されないが、それらに記載された通りの、抗体19D12、ならびにポリヌクレオチドによってプラズミド15H12/19D12HCA(γ4)にエンコード化され、番号PTA‐5214下でATCCに寄託された重鎖と、ポリヌクレオチドによってプラズミド15H12/19D12LCF(κ)にエンコード化され、番号PTA‐5220下でATCCに寄託された軽鎖とを備えた抗体を含むもの。
(viii)米国公開第2004/0202655号明細書(2004年10月14日発行)において、以下に限定されないが、それに記載された通りの抗体、PINT‐6A1、PINT‐7A2、PINT‐7A4、PINT‐7A5、PINT‐7A6、PINT‐8A1、PINT‐9A2、PINT‐11A1、PINT‐11A2、PINT‐11A3、PINT‐11A4、PINT‐11A5、PINT‐11A7、PINT‐11A12、PINT‐12A1、PINT‐12A2、PINT‐12A3、PINT‐12A4、およびPINT‐12A5を含むもの。それらはそれぞれかつ全てが参照によりそっくりそのまま、特にIGF‐1受容体を標的にする上述の抗体、ペプチ体、および関連タンパク質などについて、本明細書に組み込まれる。
Claims (14)
- 注入器であって、
内部表面を備えた壁と内部表面を備えた封止アセンブリとを含む容器にして、壁および封止アセンブリの内部表面は薬剤が充填された閉鎖無菌貯留部を画定し、封止アセンブリが封止アセンブリの内部表面を画定する内部表面を有する可撓性の壁と、可撓性の壁の外部に配設された障壁にして、可撓性の壁および障壁の間に密閉空間を画定する障壁とを有し、密閉空間が容器内に配設される、容器と、
保管状態では障壁を通しておよび密閉空間の中へと配設され、送達状態では封止アセンブリの可撓性の壁の内部表面を通して無菌貯留部の中へと配設される先端を有する無菌の容器の針を備える流体送達システムと、
容器の針を保管状態から送達状態に移動するように適合された作動器と
を備える注入器。 - 無菌の容器の針が保管状態では貯留部と流体連通しておらず、無菌の容器の針が送達状態では貯留部と流体連通している、請求項1に記載の注入器。
- 容器が穿孔を画定する、請求項2に記載の注入器。
- 穿孔内で受け取られ、穿孔に沿って移動可能なストッパをさらに備える、請求項3に記載の注入器。
- 可撓性の一体型の壁が、容器の開口部に亘って配設されて容器の壁に固定して取り付けられた隔壁を画定する、請求項1に記載の注入器。
- 障壁が、開口部に亘って配設されて容器の壁に固定して取り付けられた隔壁を画定する、請求項1に記載の注入器。
- 容器の壁が穿孔を画定し、可撓壁と障壁はそれぞれ穿孔に沿って移動可能であるストッパを画定する、請求項1に記載の注入器。
- 可撓性の一体型の壁は穿孔に沿って移動可能なストッパを画定する、請求項4に記載の注入器。
- 容器の壁が、ストッパの反対側の閉鎖端とストッパが配設される開放端とを画定する、請求項8に記載の注入器。
- 流体送達システムがさらに、容器の針に第1端で、無菌注入針を遮断する無菌カバー内に受け取られる無菌注入針に第2端で接続される無菌可撓管を備える、請求項1から9のいずれか一項に記載の注入器。
- 薬剤が、(a)赤血球造血刺激因子製剤、(b)顆粒球コロニー刺激因子、(c)TNF遮断薬、(d)ペグ型顆粒球コロニー刺激因子、(e)インターロイキン受容体特異抗体、(f)IGF‐受容体(インシュリン成長因子受容体)、(g)TGF‐特異抗体、(h)PCSK9(プロタンパク質転換サブチリシン/ケクシン9型)‐特異抗体、のいずれか一つを或る量だけ備える、請求項1から10のいずれか一項に記載の注入器。
- 請求項1に記載の注入器を組み立てる方法であって、
無菌条件下で容器の無菌貯留部に薬剤を充填するステップにして、貯留部は容器の壁の内部表面によって画定される、ステップと、
無菌条件下で容器に無菌流体送達システムを取り付けるステップにして、流体送達システムは、容器の針、注入針、および容器の針と注入針とを互いに接続する可撓性管を含み、流体送達システムは送達状態では貯留部と容器の針を通じて流体連通しており、保管状態では貯留部と流体連通しているか流体連通していないかのいずれかである、ステップと、
クリーンルーム条件下で注入器の残りの部分を組み立てるステップとを備え、
無菌条件は、クリーンルーム条件よりも高いレベルの汚染不在状態を有する、方法。 - 請求項1に記載の注入器を組み立てる方法であって、
無菌条件下で容器の無菌貯留部に薬剤を充填するステップにして、貯留部は容器の壁の内部表面によって画定され、無菌流体送達システムに取り付けられ、流体送達システムは、容器の針、注入針、および容器の針と注入針とを互いに接続する可撓性管を含み、流体送達システムは送達状態では貯留部と容器の針を通じて流体連通しており、保管状態では貯留部と流体連通しているか流体連通していないかのいずれかである、ステップと、
クリーンルーム条件下で注入器の残りの部分を組み立てるステップとを備え、
無菌条件は、クリーンルーム条件よりも高いレベルの汚染不在状態を有する、方法。 - 注入器の残りの部分を組み立てるステップが、
クリーンルーム条件下で流体送達システムを作動器に取り付けるステップにして、作動器は流体送達システムの状態を保管状態から送達状態に変更するように適合される、ステップを備える、請求項12または13に記載の方法。
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