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
- Prior art date
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- 238000000746 purification Methods 0.000 claims 9
- 239000000706 filtrate Substances 0.000 claims 8
- 238000004587 chromatography analysis Methods 0.000 claims 6
- 238000005571 anion exchange chromatography Methods 0.000 claims 4
- 241000700605 Viruses Species 0.000 claims 3
- 238000001471 micro-filtration Methods 0.000 claims 3
- 230000003612 virological Effects 0.000 claims 3
- 238000011097 chromatography purification Methods 0.000 claims 2
- 239000000805 composite resin Substances 0.000 claims 2
- 239000012043 crude product Substances 0.000 claims 2
- 239000012527 feed solution Substances 0.000 claims 2
- 239000002994 raw material Substances 0.000 claims 2
- 229920002033 ribozyme Polymers 0.000 claims 2
- 238000001542 size-exclusion chromatography Methods 0.000 claims 2
- 125000000129 anionic group Chemical group 0.000 claims 1
- 239000002158 endotoxin Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 238000000108 ultra-filtration Methods 0.000 claims 1
Claims (10)
(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.
(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.
(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.
(S6) The purification apparatus according to claim 8, further comprising a ribozyme treatment unit including an addition device for adding ribozyme.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2023210248A JP2024041758A (en) | 2018-03-28 | 2023-12-13 | Method for large-scale preparation of refined preparation of recombinant lentiviral vector at gmp grade |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810264813.X | 2018-03-28 | ||
CN201810264813.XA CN110317832B (en) | 2018-03-28 | 2018-03-28 | GMP (good manufacturing practice) scale preparation method of purified preparation of recombinant lentiviral vector |
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 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2023210248A Division JP2024041758A (en) | 2018-03-28 | 2023-12-13 | Method for large-scale preparation of refined preparation of recombinant lentiviral vector at gmp grade |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2021518757A JP2021518757A (en) | 2021-08-05 |
JPWO2019184995A5 true JPWO2019184995A5 (en) | 2022-03-15 |
Family
ID=68058553
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2020552824A Pending JP2021518757A (en) | 2018-03-28 | 2019-03-28 | Methods for large-scale preparation of purified preparations of recombinant wrench-will vector in GMP grade |
JP2023210248A Pending JP2024041758A (en) | 2018-03-28 | 2023-12-13 | Method for large-scale preparation of refined preparation of recombinant lentiviral vector at gmp grade |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2023210248A Pending JP2024041758A (en) | 2018-03-28 | 2023-12-13 | Method for large-scale preparation of refined preparation of recombinant lentiviral vector at gmp grade |
Country Status (8)
Country | Link |
---|---|
US (2) | US12018293B2 (en) |
EP (1) | EP3778905A4 (en) |
JP (2) | JP2021518757A (en) |
KR (1) | KR20200136448A (en) |
CN (1) | CN110317832B (en) |
AU (1) | AU2019241300A1 (en) |
SG (1) | SG11202009824WA (en) |
WO (1) | WO2019184995A1 (en) |
Families Citing this family (8)
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CN110317791A (en) | 2018-03-29 | 2019-10-11 | 西比曼生物科技(香港)有限公司 | The method of GMP grades of serum free suspension cell large-scale production slow virus |
CN110714029B (en) * | 2019-11-06 | 2024-08-16 | 无锡生基医药科技有限公司 | Method and system for totally-enclosed production of lentiviral vector |
CN111876392A (en) * | 2020-06-30 | 2020-11-03 | 恒瑞源正(上海)生物科技有限公司 | Method for large-scale rapid production of viral vectors |
CN111876393A (en) * | 2020-06-30 | 2020-11-03 | 恒瑞源正(上海)生物科技有限公司 | Method for large-scale rapid production of high-purity high-activity lentiviral vector |
CN116590346B (en) * | 2020-09-15 | 2024-05-14 | 上海药明巨诺生物医药研发有限公司 | Lentiviral vector purification method |
CN113373120B (en) * | 2021-06-18 | 2022-04-26 | 浙江康佰裕生物科技有限公司 | Purification method and application of GMP-grade retrovirus vector |
CN113667596A (en) * | 2021-08-20 | 2021-11-19 | 上海药明生基医药科技有限公司 | Low-temperature blending device for preparing lentiviral vector and purification method of lentiviral vector |
CN116769736B (en) * | 2023-08-17 | 2023-11-14 | 赛奥斯博生物科技(北京)有限公司 | Production process for rapidly purifying lentivirus |
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2018
- 2018-03-28 CN CN201810264813.XA patent/CN110317832B/en active Active
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2019
- 2019-03-28 AU AU2019241300A patent/AU2019241300A1/en active Pending
- 2019-03-28 SG SG11202009824WA patent/SG11202009824WA/en unknown
- 2019-03-28 EP EP19778302.0A patent/EP3778905A4/en active Pending
- 2019-03-28 WO PCT/CN2019/080213 patent/WO2019184995A1/en unknown
- 2019-03-28 KR KR1020207030556A patent/KR20200136448A/en unknown
- 2019-03-28 US US17/042,125 patent/US12018293B2/en active Active
- 2019-03-28 JP JP2020552824A patent/JP2021518757A/en active Pending
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2020
- 2020-09-28 US US17/034,168 patent/US20210147826A1/en active Pending
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2023
- 2023-12-13 JP JP2023210248A patent/JP2024041758A/en active Pending
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