JP2009077707A - 血液製剤中の汚染物質を不活性化する方法 - Google Patents
血液製剤中の汚染物質を不活性化する方法 Download PDFInfo
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Abstract
【解決手段】血液製剤にCタイプ紫外線を1回又は2回以上照射して、前記血液製剤中に存在するウイルス、特にパルボウィルスを不活性化する方法。
【選択図】図1
Description
この発明は、本発明の方法によって処理された血液製剤及び前記血液製剤を含む医薬用及び/または化粧品用組成物にも係わる。
ヒトのパルボウィルスを使用することによって起こる問題及びこれらのパルボウィルス、特にパルボウィルスB19をインビトロ培養することに伴う問題を考慮して、形状及びサイズが極めて似ているマウスのパルボウィルスMVMpを、パルボウィルスB19の不活性化方法開発のモデルとして使用する。マウスのパルボウィルスMVMpを選択した理由は、このタイプのパルボウィルスが紫外線照射または温度変更による不活性化に対してパルボウィルスB19よりも感度が低いことにある。
ヨーロッパ共同体の勧告(EEC Regulatory Document not for guidance,Biologicals 1991,19,p.251)に従ってウィルス減少指数を測定し、対数減少の形で表わした。タイターの測定は、Tattersall P.が記述している方法(J.Virol.,10,pp.586−590(1972))及びRussell S.J.et al.が記述している方法(J.Virol.,66,pp.2821−2828(1992))に従って行うことができる。
この発明の方法(各工程)及びそれを実施するための装置は、ヨーロッパの関係機関が要求する実施条件(CPMP/BWP/268/95及びCPMP/BWP/269/95−それぞれ1996年8月14日及び9月13日から発効(参考のためこの明細書中に引用))に合致する。これらの機関の勧告(§5.2.1(1)CPMP/BWP/269/95)通り、この発明の方法及びそれを実施するための装置は、エンベロープのないウィルス、特にパルボウィルスに対する有効処理工程を少なくとも1つ含んでいる(§5.2.2(iii))。この発明は、特に不活性化条件、即ち、5〜9対数減少(Annex I CPMP/BWP/268/95参照)を満たしている。即ち、接種されたウィルスを残らず排除することができる。事実、発明者は、処理後、検出閾値以上のウィルス増殖を観察できなかった。
他の処理ずみ血液製剤でも同様の結果が得られる。
Claims (11)
- 血液製剤にCタイプ紫外線を1回以上照射して前記血液製剤中に存在するウィルスを不活性化する方法において、
前記血液製剤に前記Cタイプ紫外線を照射するために石英管または前記Cタイプ紫外線を吸収しないポリマー材から成る管の中で前記血液製剤を循環させることと、
乱流システムにより前記管内を循環する前記血液製剤の流れを均質化することによって、前記管では、薄層状態にない前記血液製剤を処理し、前記血液製剤が薄層状態である場合に前記管の固相/液相界面に発生する破壊現象を回避することとを特徴とする前記ウィルスを不活性化する方法。 - 前記乱流システムが、バッフルおよび窒素添加のいずれかである請求項1に記載の方法。
- 前記血液製剤が血清、血漿及び血中プロテイン成分から成るグループから選択されることを特徴とする請求項1または請求項2に記載の方法。
- 前記血中プロテイン成分が凝固因子であることを特徴とする請求項3に記載の方法。
- 前記凝固因子が、因子VIII,因子IX,フォン・ウィルブラント因子、フィブリノーゲン、フィブロネクチンから成るグループから選択されることを特徴とする請求項4に記載の方法。
- 前記血中プロテイン成分が免疫グロブリン、アルブミンから成るグループから選択されることを特徴とする請求項3に記載の方法。
- 前記Cタイプ紫外線の照射が250〜270nmで行われることを特徴とする請求項1から請求項6のいずれか1項に記載の方法。
- 前記Cタイプ紫外線の照射が254nmを含む波長で行われることを特徴とする請求項1から請求項7のいずれか1項に記載の方法。
- 1つ以上の物理的および化学的いずれかのウィルス不活性化処理と組合わせることを特徴とする請求項1から請求項8のいずれか1項に記載の方法。
- 前記物理的ウィルス不活性化処理に1回以上の加熱工程が含まれることを特徴とする請求項9に記載の方法。
- 全血から前記血液製剤を単離または分離する方法と組合わせることを特徴とする請求項1から請求項10のいずれか1項に記載の方法。
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PCT/BE1995/000069 WO1996002571A1 (fr) | 1994-07-14 | 1995-07-14 | Concentre de fibrinogene issu de plasma sanguin, procede et installation pour sa preparation |
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JP2008207608A Pending JP2009077707A (ja) | 1995-07-14 | 2008-08-12 | 血液製剤中の汚染物質を不活性化する方法 |
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US (2) | US6190608B1 (ja) |
EP (2) | EP0840624B1 (ja) |
JP (2) | JPH11509210A (ja) |
AT (1) | ATE367830T1 (ja) |
CA (1) | CA2225470C (ja) |
DE (3) | DE29624488U1 (ja) |
DK (1) | DK0840624T3 (ja) |
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DE69637181T2 (de) | 2008-04-17 |
EP0840624A1 (fr) | 1998-05-13 |
WO1997003706A1 (fr) | 1997-02-06 |
CA2225470C (en) | 2010-06-29 |
US6833108B2 (en) | 2004-12-21 |
DE69637181D1 (de) | 2007-09-06 |
EP1842561A1 (fr) | 2007-10-10 |
JPH11509210A (ja) | 1999-08-17 |
EP0840624B1 (fr) | 2007-07-25 |
US20010046450A1 (en) | 2001-11-29 |
DE96923791T1 (de) | 2004-07-08 |
ATE367830T1 (de) | 2007-08-15 |
DK0840624T3 (da) | 2007-11-05 |
US6190608B1 (en) | 2001-02-20 |
DE29624488U1 (de) | 2004-04-15 |
CA2225470A1 (en) | 1997-02-06 |
ES2290957T3 (es) | 2008-02-16 |
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