JP6433954B2 - 凍結乾燥されたウイルス製剤 - Google Patents
凍結乾燥されたウイルス製剤 Download PDFInfo
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- JP6433954B2 JP6433954B2 JP2016170628A JP2016170628A JP6433954B2 JP 6433954 B2 JP6433954 B2 JP 6433954B2 JP 2016170628 A JP2016170628 A JP 2016170628A JP 2016170628 A JP2016170628 A JP 2016170628A JP 6433954 B2 JP6433954 B2 JP 6433954B2
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- FJHBOVDFOQMZRV-XQIHNALSSA-N xanthophyll Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C=C(C)C(O)CC2(C)C FJHBOVDFOQMZRV-XQIHNALSSA-N 0.000 description 1
- 229950003017 zeniplatin Drugs 0.000 description 1
- 150000003952 β-lactams Chemical class 0.000 description 1
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Description
本出願は、2010年12月2日に提出した米国仮出願第61/419,020号に基づく優先権を主張するものであり、この仮出願は、参照によりその全体が本明細書に取り込まれる。
本発明の好ましい実施形態において、例えば以下の項目が提供される。
(項目1)
以下を含むウイルス製剤であって、
(a)精製ウイルスおよび
(b)以下を含む非ウイルス組成物
(i)マンニトール
(ii)ソルビトール
(iii)ヒスチジンおよび
(iv)Mg2+
ウイルス製剤は凍結乾燥されており、
非ウイルス組成物は、凍結乾燥の前に液体担体をさらに含む液体非ウイルス組成物であり、
液体非ウイルス組成物中のソルビトールの濃度は、液体非ウイルス組成物の重量に基づいて3%未満であり、
液体非ウイルス組成物は、液体担体を除いて、一価の陽イオン塩が実質的にないウイルス製剤。
(項目2)
マンニトールおよびソルビトールを組み合わせた濃度は、液体非ウイルス組成物の重量に基づいて10重量%未満である項目1に記載の製剤。
(項目3)
以下を含むウイルス製剤であって、
(a)精製ウイルスおよび
(b)以下を含む非ウイルス組成物
(i)マンニトール
(ii)ソルビトール
(iii)ヒスチジンおよび
(iv)Mg2+
ウイルス製剤は凍結乾燥されており、
非ウイルス組成物は、凍結乾燥の前に液体担体をさらに含む液体非ウイルス組成物であり、
液体非ウイルス組成物中の糖類の濃度は、液体非ウイルス組成物の重量に基づいて7.5重量%未満であるウイルス製剤。
(項目4)
液体非ウイルス組成物中のマンニトールおよびソルビトールを組み合わせた濃度は、液体非ウイルス組成物の重量に基づいて7%未満である項目3に記載の製剤。
(項目5)
非ウイルス組成物は非イオン性界面活性剤をさらに含む項目1〜4のいずれかに記載の製剤。
(項目6)
ウイルス製剤はZn2+が実質的にない項目1〜5のいずれかに記載の製剤。
(項目7)
ウイルス製剤はトレハロースが実質的にない項目1〜6のいずれかに記載の製剤。
(項目8)
以下を含むウイルス製剤であって、
(a)精製ウイルスおよび
(b)以下を含む非ウイルス組成物
(i)ショ糖
(ii)Mg2+および
(iii)非イオン性界面活性剤
ウイルス製剤は凍結乾燥されており、
非ウイルス組成物は、凍結乾燥の前に液体担体をさらに含む液体非ウイルス組成物であり、
液体非ウイルス組成物中のショ糖の濃度は、凍結乾燥の前に液体非ウイルス組成物の重量に基づいて5%未満であり、および
液体非ウイルス組成物は、液体担体を除いて、一価の陽イオン塩、非ショ糖ポリオール類、およびカルボン酸塩類が実質的にないウイルス製剤。
(項目9)
以下から本質的になるウイルス製剤であって、
(a)精製ウイルスおよび
(b)以下を含む非ウイルス組成物
(i)ショ糖
(ii)Mg2+および
(iii)非イオン性界面活性剤
ウイルス製剤は凍結乾燥されており、
非ウイルス組成物は、凍結乾燥の前に液体担体をさらに含む液体非ウイルス組成物であり、
液体非ウイルス組成物中のショ糖の濃度は、凍結乾燥の前に液体非ウイルス組成物の重量に基づいて5%未満であるウイルス製剤。
(項目10)
ウイルスは腫瘍溶解性ウイルスである項目1〜9のいずれかに記載の製剤。
(項目11)
ウイルスは非エンベロープ型ウイルスである項目1〜9のいずれかに記載の製剤。
(項目12)
ウイルスはレオウイルスである項目1〜11のいずれかに記載の製剤。
(項目13)
レオウイルスは哺乳動物のレオウイルスである項目12に記載の製剤。
(項目14)
哺乳動物のレオウイルスはヒトのレオウイルスである項目13に記載の製剤。
(項目15)
ヒトのレオウイルスはセロタイプ3ウイルスである項目14に記載の製剤。
(項目16)
セロタイプ3ウイルスはDearing株である項目15に記載の製剤。
(項目17)
レオウイルスは遺伝子組み換えまたはリアソートされた(reassorted)レオウイルスである項目12に記載の製剤。
(項目18)
レオウイルスはIDAC#190907−01である項目12に記載の製剤。
(項目19)
Mg2+は塩化マグネシウムとして存在する項目1〜17のいずれかに記載の製剤。
(項目20)
非イオン性界面活性剤はポリソルベート80である項目5、8、または9のいずれかに記載の製剤。
(項目21)
液体担体は水性担体である項目1〜20のいずれかに記載の製剤。
(項目22)
水性担体は水である項目21に記載の製剤。
(項目23)
ウイルス製剤は約周囲温度の温度で安定的である項目1〜22のいずれかに記載の製剤。
(項目24)
ウイルス製剤は約周囲温度の温度で少なくとも1日間安定的である項目1〜23のいずれかに記載の製剤。
(項目25)
ウイルス製剤は約4℃またはそれより低い温度で少なくとも3ヵ月間安定的である項目1〜22のいずれかに記載の製剤。
(項目26)
ウイルス製剤は約4℃またはそれより低い温度で少なくとも6ヵ月間安定的である項目1〜25のいずれかに記載の製剤。
(項目27)
ウイルス製剤は約4℃またはそれより低い温度で少なくとも12ヵ月間安定的である項目1〜26のいずれかに記載の製剤。
(項目28)
ウイルス製剤は約4℃またはそれより低い温度で少なくとも18ヵ月間安定的である項目1〜27のいずれかに記載の製剤。
(項目29)
投与の前に再構成に適する項目1〜28のいずれかに記載の製剤。
(項目30)
以下のステップを含むウイルス製剤の作製方法であって、
(a)ウイルスを与え、
(b)ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成し、液体非ウイルス組成物は以下を含み、
(i)マンニトール
(ii)濃度が液体非ウイルス組成物の重量に基づいて3%未満のソルビトール
(iii)ヒスチジン
(iv)Mg2+および
(v)液体担体、
および非ウイルス組成物は、液体担体を除いて、一価の陽イオン塩が実質的になく、並びに
(c)液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成する方法。
(項目31)
非ウイルス組成物中のマンニトールおよびソルビトールを組み合わせた濃度は、非ウイルス組成物の重量に基づいて10重量%未満である項目30に記載の方法。
(項目32)
以下のステップを含むウイルス製剤の作製方法であって、
(a)ウイルスを与え、
(b)ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成し、液体非ウイルス組成物は以下を含み、
(i)マンニトール
(ii)ソルビトール
(iii)ヒスチジン
(iv)Mg2+および
(v)液体担体、
および液体非ウイルス製剤中の糖類の濃度は、凍結乾燥の前に液体非ウイルス製剤の重量に基づいて7.5重量%未満であり、並びに
(c)液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成する方法。
(項目33)
非ウイルス組成物中のマンニトールおよびソルビトールを組み合わせた濃度は、非ウイルス組成物の重量に基づいて7重量%未満である項目32に記載の方法。
(項目34)
液体非ウイルス組成物に非イオン性界面活性剤を加えることをさらに含む項目30〜33のいずれかに記載の方法。
(項目35)
ウイルス製剤はZn2+が実質的にない項目30〜34のいずれかに記載の方法。
(項目36)
ウイルス製剤はトレハロースが実質的にない項目30〜35のいずれかに記載の方法。(項目37)
以下のステップを含むウイルス製剤の作製方法であって、
(a)ウイルスを与え、
(b)ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成し、液体非ウイルス組成物は以下を含み、
(i)濃度が液体非ウイルス組成物の重量に基づいて5%未満のショ糖、
(ii)Mg2+、
(iii)非イオン性界面活性剤、および
(iv)液体担体、
および液体非ウイルス組成物は、液体担体を除いて、一価の陽イオン塩、非ショ糖ポリオール類、およびカルボン酸塩類が実質的になく、並びに
(c)液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成する方法。
(項目38)
以下のステップを含むウイルス製剤の作製方法であって、
(a)ウイルスを与え、
(b)ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成し、液体非ウイルス組成物は本質的に以下からなり、
(i)濃度が液体非ウイルス組成物の重量に基づいて5%未満のショ糖、
(ii)Mg2+、
(iii)非イオン性界面活性剤、および
(iv)液体担体、並びに
(d)液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成する方法。
(項目39)
項目30〜38のいずれかに記載の方法であって、液体ウイルス製剤を凍結乾燥させることが、
(a)液体ウイルス製剤を0℃より低い温度まで凍結し、凍結されたウイルス製剤を形成し、および
(b)凍結されたウイルス製剤を真空に供することを含む、方法。
(項目40)
凍結乾燥されたウイルス製剤を再構成することをさらに含む項目30〜39のいずれかに記載の方法。
(項目41)
凍結乾燥されたウイルス製剤を再構成することは、凍結乾燥されたウイルス製剤を培地に溶解または懸濁することを含む項目40に記載の方法。
(項目42)
ウイルスは腫瘍溶解性ウイルスである項目30〜41のいずれかに記載の方法。
(項目43)
ウイルスは非エンベロープ型ウイルスである項目30〜42のいずれかに記載の方法。(項目44)
ウイルスはレオウイルスである項目30〜43のいずれかに記載の方法。
(項目45)
レオウイルスは哺乳動物のレオウイルスである項目44に記載の方法。
(項目46)
哺乳動物のレオウイルスはヒトのレオウイルスである項目45に記載の方法。
(項目47)
ヒトのレオウイルスはセロタイプ3ウイルスである項目46に記載の方法。
(項目48)
セロタイプ3ウイルスはDearing株である項目47に記載の方法。
(項目49)
レオウイルスは遺伝子組み換えまたはリアソートされた(reassorted)レオウイルスである項目44に記載の方法。
(項目50)
レオウイルスはIDAC#190907−01である項目44に記載の方法。
(項目51)
Mg2+は塩化マグネシウムとして存在する項目30〜50のいずれかに記載の方法。(項目52)
非イオン性界面活性剤はポリソルベート80である項目34、37、または38に記載の方法。
(項目53)
液体担体は水性担体である項目30〜52のいずれかに記載の方法。
(項目54)
水性担体は水である項目53に記載の方法。
(項目55)
項目30〜54に記載の方法に従って調製されるウイルス製剤。
(項目56)
ウイルスを保存または安定化させる方法であって、項目1〜28のいずれかに記載のウイルス製剤を調製し、およびウイルス製剤を保管する方法。
(項目57)
ウイルスは周囲温度またはそれより低い温度で保管される項目56に記載の方法。
(項目58)
温度は周囲温度である項目56または57に記載の方法。
(項目59)
温度は2℃〜8℃である項目56または57に記載の方法。
(項目60)
温度は4℃である項目59に記載の方法。
(項目61)
温度は−20℃である項目56または57に記載の方法。
(項目62)
温度は−60℃〜−80℃である項目56または57に記載の方法。
(項目63)
項目1〜29のいずれかに記載のウイルス製剤を調製することを含む非凝集のウイルス製剤を調製する方法。
(項目64)
製剤は非経口の注入または注射による投与に適する項目63に記載の方法。
Williams&Wilkins、2005に認めることができる。
組成物1および2を表1に示す成分を混合することによって調製した。
対照のレオウイルス製剤(対照製剤)は、リン酸緩衝食塩水(PBS)中にレオウイルスを与え、さらに追加のPBSで混合物を希釈し、3x1010TCID50/mLの標的総ウイルス粒子の力価を得て、およびウイルス製剤を凍結乾燥することによって調製した。製剤1はPBS中にレオウイルスを与え、組成物1との混合物を希釈し、3x1010TCID50/mLの標的総ウイルス粒子の力価を得て、およびウイルス製剤を凍結乾燥することによって調製した。製剤2はPBS中にレオウイルスを与え、組成物2との混合物を希釈し、3x1010TCID50/mLの標的総ウイルス粒子の力価を得て、およびウイルス製剤を凍結乾燥することによって調製した。
対照製剤、製剤1、および製剤2の感染性粒子の力価(TCID50/mL)は、実施例2で調製したように、調製後に周囲温度で測定した(すなわち、時間=0)。対照製剤は、t=0のとき、検出限界より低く、生存できるウイルスは存在しなかったことを示した。したがって、対照製剤はその後のいかなる時点でも試験しなかった。製剤1および2は、37℃、周囲温度、2℃〜8℃の温度、−20℃、および−80℃を含む異なる温度で0、3、6.5、12および18.5ヵ月間保管した。保管期間の後、各温度での製剤のそれぞれのTCID50データを3通りで測定した。製剤1および2の平均のデータ値を図1に示す。製剤1および2の感染性粒子の力価の回復を図2に示す。ウイルス力価は、対照力価のアッセイ間の変化を説明するために、標準化した。HPLCによって計測された標準化された総ウイルス力価は、製剤1については図3に、製剤2については図4に示す。
対照製剤および組成物1の試料は、上述のように、凍結乾燥の前に、USP <788>のLight Obscuration Particle Count Testを用いて微粒子状物質について試験をおこなった。結果は表2に示すように、組成物1で調製したウイルス製剤のほうが、対照製剤を用いるウイルス製剤より粒子がかなり少なかった。
Claims (14)
- ウイルス製剤であって、該ウイルス製剤は、以下:
(a)精製ウイルス、および
(b)以下を含む非ウイルス組成物
(i)ショ糖、
(ii)Mg2+、および
(iii)ポリソルベート80
を含み、
該ウイルス製剤は凍結乾燥されており、
該非ウイルス組成物は、凍結乾燥の前に、リン酸緩衝食塩水をさらに含む液体非ウイルス組成物であり、
該液体非ウイルス組成物中のショ糖の濃度は、凍結乾燥の前に、該液体非ウイルス組成物の重量に基づいて5%未満であり、
該液体非ウイルス組成物には、一価の陽イオン塩、非ショ糖ポリオールおよびカルボン酸塩類がない、ウイルス製剤。 - ウイルス製剤であって、該ウイルス製剤は、以下:
(a)精製ウイルスおよび
(b)以下を含む非ウイルス組成物
(i)ショ糖、
(ii)Mg2+、および
(iii)ポリソルベート80
から本質的になり、
該ウイルス製剤は凍結乾燥されており、
該非ウイルス組成物は、凍結乾燥の前に、リン酸緩衝食塩水をさらに含む液体非ウイルス組成物であり、
該液体非ウイルス組成物中のショ糖の濃度は、凍結乾燥の前に、該液体非ウイルス組成物の重量に基づいて5%未満である、ウイルス製剤。 - 前記ウイルスは腫瘍溶解性ウイルス、非エンベロープ型ウイルス、またはレオウイルスであり、必要に応じて、該レオウイルスは哺乳動物のレオウイルス、ヒトのレオウイルス、セロタイプ3ウイルス、Dearing株セロタイプ3ウイルス、遺伝子組み換えもしくはリアソートされたレオウイルス、またはIDAC#190907−01である、請求項1または2のいずれかに記載の製剤。
- Mg2+は塩化マグネシウムとして存在する、請求項1〜3のいずれかに記載の製剤。
- 前記ウイルス製剤は約4℃またはそれより低い温度で少なくとも3ヵ月間、少なくとも6ヵ月間、少なくとも12ヵ月間、または少なくとも18ヵ月間安定的である、請求項1〜4のいずれかに記載の製剤。
- 投与の前に再構成に適する、請求項1〜5のいずれかに記載の製剤。
- ウイルス製剤の作製方法であって、該方法は、
(a)ウイルスを与えるステップ、
(b)該ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成するステップであって、該液体非ウイルス組成物は以下を含み、
(i)濃度が該液体非ウイルス組成物の重量に基づいて5%未満のショ糖、
(ii)Mg2+、
(iii)ポリソルベート80、および
(iv)リン酸緩衝食塩水、
ここで、該液体非ウイルス組成物には、一価の陽イオン塩、非ショ糖ポリオールおよびカルボン酸塩類がない、ステップ、並びに
(c)該液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成するステップ
を含む、方法。 - ウイルス製剤の作製方法であって、該方法は、
(a)ウイルスを与えるステップ、
(b)ウイルスおよび液体非ウイルス組成物を組み合わせて液体ウイルス製剤を形成するステップであって、該液体非ウイルス組成物は本質的に以下からなるステップ、
(i)濃度が該液体非ウイルス組成物の重量に基づいて5%未満のショ糖、
(ii)Mg2+、
(iii)ポリソルベート80、および
(iv)リン酸緩衝食塩水、
並びに
(d)該液体ウイルス製剤を凍結乾燥させ、ウイルス製剤を形成するステップ
を含む、方法。 - 前記液体ウイルス製剤を凍結乾燥させることが、
(a)該液体ウイルス製剤を0℃より低い温度まで凍結し、凍結されたウイルス製剤を形成すること、および
(b)該凍結されたウイルス製剤を真空に供することを含む、請求項7または8に記載の方法。 - 前記凍結乾燥されたウイルス製剤を再構成するステップをさらに含み、
ここで、必要に応じて、該凍結乾燥されたウイルス製剤を再構成するステップは、該凍結乾燥されたウイルス製剤を培地に溶解または懸濁することを含む、請求項7〜9のいずれかに記載の方法。 - ウイルスを保存または安定化させる方法であって、
請求項1〜6のいずれかに記載のウイルス製剤を調製するステップ、および
該ウイルス製剤を保管するステップを含み、
ここで、必要に応じて、該ウイルスは周囲温度より低い温度で保管される、方法。 - 前記温度は、2℃〜8℃、4℃、−20℃、または−60℃〜−80℃である、請求項11に記載の方法。
- 請求項1〜6のいずれかに記載のウイルス製剤を調製するステップを含む、非凝集のウイルス製剤を調製する方法。
- 前記製剤は非経口の注入または注射による投与に適する、請求項13に記載の方法。
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JP2018172443A (ja) | 2018-11-08 |
MX349294B (es) | 2017-07-21 |
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JP2016199591A (ja) | 2016-12-01 |
JP6034797B2 (ja) | 2016-11-30 |
AU2011336410A1 (en) | 2013-03-28 |
CN103269716A (zh) | 2013-08-28 |
TW201233803A (en) | 2012-08-16 |
KR20140014096A (ko) | 2014-02-05 |
AU2011336410B2 (en) | 2015-01-22 |
IL226646B (en) | 2018-02-28 |
JP2013544288A (ja) | 2013-12-12 |
KR102023207B1 (ko) | 2019-11-25 |
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EA201390812A1 (ru) | 2013-11-29 |
MX2013006169A (es) | 2013-10-28 |
EP2646052A2 (en) | 2013-10-09 |
DK2646052T3 (en) | 2017-07-17 |
WO2012075376A3 (en) | 2012-08-16 |
WO2012075376A2 (en) | 2012-06-07 |
CA2819236A1 (en) | 2012-06-07 |
US20150224198A1 (en) | 2015-08-13 |
US9044498B2 (en) | 2015-06-02 |
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CN103269716B (zh) | 2015-05-27 |
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