JPWO2019184995A5 - - Google Patents

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JPWO2019184995A5
JPWO2019184995A5 JP2020552824A JP2020552824A JPWO2019184995A5 JP WO2019184995 A5 JPWO2019184995 A5 JP WO2019184995A5 JP 2020552824 A JP2020552824 A JP 2020552824A JP 2020552824 A JP2020552824 A JP 2020552824A JP WO2019184995 A5 JPWO2019184995 A5 JP WO2019184995A5
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Prior art keywords
chromatography
purification
unit
filtrate
purified
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JP2020552824A
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JP2021518757A (en
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Priority claimed from CN201810264813.XA external-priority patent/CN110317832B/en
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Publication of JP2021518757A publication Critical patent/JP2021518757A/en
Publication of JPWO2019184995A5 publication Critical patent/JPWO2019184995A5/ja
Priority to JP2023210248A priority Critical patent/JP2024041758A/en
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Claims (10)

組換えウイルスベクターの大規模精製のための方法であって、以下の工程：
(ａ) 精製の対象となる組換えウイルスベクターを含む供給液である原料を提供する工程；
(ｂ) 前記供給液に対して精密濾過処理を実施し、前記組換えウイルスベクターを含む精密濾過された濾液を得る工程；
(ｃ) 必要に応じて、前記濾液を濃縮して濃縮濾液を得る工程；
(ｄ) 前記濾液をクロマトグラフィーにより精製し、組換えウイルスベクターを含む粗純生成物を得る工程；
(ｅ) 前記粗純生成物を液体交換及び精製して精製組換えウイルスベクターを得る工程；
を含み、
ここで、前記クロマトグラフィーは、陰イオン交換クロマトグラフィー、サイズ排除クロマトグラフィー、マルチモード複合樹脂クロマトグラフィー、またはそれらの組み合わせから選択される、方法。 A method for large-scale purification of recombinant viral vectors, the following steps:
(a) A step of providing a raw material as a feed solution containing a recombinant virus vector to be purified;
(b) A step of performing a microfiltration treatment on the feed solution to obtain a microfiltered filtrate containing the recombinant virus vector;
(c) If necessary, the step of concentrating the filtrate to obtain a concentrated filtrate;
(d) A step of purifying the filtrate by chromatography to obtain a crude product containing a recombinant viral vector;
(e) A step of liquid exchange and purification of the crude product to obtain a purified recombinant viral vector;
Including
Here, the chromatography is selected from anion exchange chromatography, size exclusion chromatography, multimode composite resin chromatography, or a combination thereof. 前記陰イオン交換クロマトグラフィーにおけるアニオン性樹脂が、Ｃａｐｔｏ Ｑ、ＣａｐｔｏＩｍｐＲｅｓ、およびＣａｐｔｏ ＤＥＡＥから選択される、請求項１に記載の方法。 The method of claim 1, wherein the anionic resin in the anion exchange chromatography is selected from Capto Q, CaptoImpRes, and Capto DEAE. クロマトグラフィーによる精製が、陰イオン交換クロマトグラフィーにより一次精製を行い、次いで、マルチモード複合樹脂クロマトグラフィーによる精製を行うことを含む、請求項１に記載の方法。 The method of claim 1, wherein purification by chromatography comprises primary purification by anion exchange chromatography followed by purification by multimode composite resin chromatography. 工程（ｄ）において、精製された組換えレンチウイルスベクターが、以下の特徴のうち１つ以上を有する、請求項１に記載の方法：
（ｐ１） 前記組換えレンチウイルスベクターの生物学的力価が約１．０６ｘ１０９ Ｔｕ／ｍＬである；
（ｐ２) ＢＳＡ＜５０ｎｇ／ｍＬ；
（ｐ３） エンドトキシン＜１ ＥＵ／ｍＬ。 The method of claim 1, wherein in step (d), the purified recombinant lentiviral vector has one or more of the following characteristics:
(P1) The biological titer of the recombinant lentiviral vector is approximately 1.06x109 Tu / mL;
(P2) BS A <50 ng / mL;
(P3) Endotoxin <1 EU / mL. 前記工程（ｃ）において、濃縮を限外濾過により行う、請求項１に記載の方法。 The method according to claim 1, wherein the concentration is carried out by ultrafiltration in the step (c). 請求項１に記載の方法によって精製された、組換えレンチウイルスベクター。 A recombinant lentiviral vector purified by the method according to claim 1. 請求項６に記載の精製された組換えレンチウイルスベクターを含む調製物。 A preparation comprising the purified recombinant lentiviral vector according to claim 6 . 請求項１に記載の方法で使用される精製装置であって、
(Ｓ１) 精製される組換えレンチウイルスベクターの原料を保持するための、任意の第１の容器；
(Ｓ２) 精製される組換えレンチウイルスベクターの精密濾過処理を行い、精密濾過された濾液を得るための、精密濾過ユニット；
(Ｓ３) 濃縮濾液を得るために濾液を濃縮するための、任意の濃縮ユニット；
(Ｓ４) 前記精密濾過ユニット又は前記濃縮ユニットからの濾液をクロマトグラフィーにより精製して精製組換えレンチウイルスベクターを得るための、クロマトグラフィー精製ユニット；
(Ｓ５) 前記精製された組換えレンチウイルスベクターを収集するための、収集ユニット；
を含む、精製装置。 A purification apparatus used by the method according to claim 1.
(S1) Any first container for holding the raw material of the recombinant lentiviral vector to be purified;
(S2) A microfiltration unit for performing a microfiltration treatment on the purified recombinant wrench virus vector to obtain a microfiltered filtrate;
(S3) Any concentrating unit for concentrating the filtrate to obtain a concentrated filtrate;
(S4) A chromatographic purification unit for purifying the filtrate from the precision filtration unit or the concentration unit by chromatography to obtain a purified recombinant lentiviral vector;
(S5) A collection unit for collecting the purified recombinant lentiviral vector;
Including purification equipment. 前記クロマトグラフィー精製ユニットが、サイズ排除クロマトグラフィーユニットおよび陰イオン交換クロマトグラフィーユニットを含む、請求項８に記載の精製装置。 The purification apparatus according to claim 8, wherein the chromatography purification unit includes a size exclusion chromatography unit and an anion exchange chromatography unit. (Ｓ６)リボザイムを添加するための添加装置を備えるリボザイム処理ユニットをさらに含む、請求項８に記載の精製装置。

(S6) The purification apparatus according to claim 8, further comprising a ribozyme treatment unit including an addition device for adding ribozyme.
JP2020552824A 2018-03-28 2019-03-28 Methods for large-scale preparation of purified preparations of recombinant wrench-will vector in GMP grade Pending JP2021518757A (en)

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CN201810264813.XA CN110317832B (en) 2018-03-28 2018-03-28 GMP (good manufacturing practice) scale preparation method of purified preparation of recombinant lentiviral vector
CN201810264813.X 2018-03-28
PCT/CN2019/080213 WO2019184995A1 (en) 2018-03-28 2019-03-28 Method for large-scale preparation of purified preparation of recombinant lentiviral vector at gmp grade

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