JP2018524668A5 - - Google Patents
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- JP2018524668A5 JP2018524668A5 JP2017559064A JP2017559064A JP2018524668A5 JP 2018524668 A5 JP2018524668 A5 JP 2018524668A5 JP 2017559064 A JP2017559064 A JP 2017559064A JP 2017559064 A JP2017559064 A JP 2017559064A JP 2018524668 A5 JP2018524668 A5 JP 2018524668A5
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- 238000004519 manufacturing process Methods 0.000 claims 3
- 238000011087 biopharmaceutical technology Methods 0.000 claims 1
- 238000010924 continuous production Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000011144 upstream manufacturing Methods 0.000 claims 1
Claims (1)
- 少なくとも2つの下流および/または上流工程の実行のため、直列に連結した少なくとも2つのユニットを備えた、バイオ医薬製品の連続的な製造および/または製剤のための製造プラントであって、前記製造プラントは、
− 少なくとも1つのスレーブユニットおよび少なくとも1つのマスターユニットを備え、
− 各スレーブユニットを、製品流に沿って同じユニットまたは隣接ユニット内のいずれかで少なくとも1つのバッファー容積と連結し、前記バッファー容積のモニターのための1つ以上のセンサーおよび前記バッファー容積に影響を及ぼすための1つ以上のアクチュエータを備え、各バッファー容積の状態変数を、クローズドアクションシークエンス内の少なくとも1つの制御装置と連結した前記センサーおよび前記アクチュエータによって制御し、
− マスターユニットは、前記製品流を運搬するための少なくとも1つの機器を備え、その流速を前記状態変数バッファー容積の制御により制御しないことを特徴とし、
− およびマスターユニットが1つ以上のスレーブユニットと隣接する場合、各スレーブユニットの前記バッファー容積と連結し、ならびに
− 複数のマスターユニットの場合、少なくとも1つの補助流が前記マスターユニットの2つの流速決定アクチュエータ間に存在する、
ことを特徴とする前記製造プラント。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15167538.6 | 2015-05-13 | ||
EP15167538.6A EP3093335A1 (de) | 2015-05-13 | 2015-05-13 | Prozessleitsystem zur regelung und steuerung einer modular aufgebauten anlage zur produktion von biopharmazeutischen und biologischen makromolekularen produkten |
PCT/EP2016/060369 WO2016180798A1 (de) | 2015-05-13 | 2016-05-10 | Prozessleitsystem zur regelung und steuerung einer modular aufgebauten anlage zur produktion von biopharmazeutischen und biologischen makromolekularen produkten |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2018524668A JP2018524668A (ja) | 2018-08-30 |
JP2018524668A5 true JP2018524668A5 (ja) | 2019-01-17 |
JP6833721B2 JP6833721B2 (ja) | 2021-02-24 |
Family
ID=53177195
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017559064A Active JP6833721B2 (ja) | 2015-05-13 | 2016-05-10 | バイオ医薬およびバイオ高分子製品の製造用モジュール型プラントの制御および規制のためのプロセス制御システム |
Country Status (22)
Country | Link |
---|---|
US (2) | US20180127461A1 (ja) |
EP (2) | EP3093335A1 (ja) |
JP (1) | JP6833721B2 (ja) |
KR (1) | KR20180005225A (ja) |
CN (1) | CN107849506B (ja) |
AR (1) | AR104554A1 (ja) |
AU (1) | AU2016259746B2 (ja) |
BR (1) | BR112017024373B1 (ja) |
CA (1) | CA2985678A1 (ja) |
DK (1) | DK3294856T3 (ja) |
ES (1) | ES2760468T3 (ja) |
HK (1) | HK1252939A1 (ja) |
IL (1) | IL255556B (ja) |
MX (1) | MX2017014527A (ja) |
PL (1) | PL3294856T3 (ja) |
PT (1) | PT3294856T (ja) |
RU (1) | RU2724495C2 (ja) |
SA (1) | SA517390330B1 (ja) |
SG (1) | SG11201709329YA (ja) |
TW (1) | TWI689303B (ja) |
WO (1) | WO2016180798A1 (ja) |
ZA (1) | ZA201708418B (ja) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3431173A1 (en) | 2017-07-19 | 2019-01-23 | Bayer Pharma Aktiengesellschaft | Continuous manufacture of guidance molecule drug conjugates |
WO2020047578A1 (en) * | 2018-09-05 | 2020-03-12 | Commonwealth Scientific And Industrial Research Organisation | "a monitor for a multi-parameter manufacturing process" |
WO2021241580A1 (ja) * | 2020-05-29 | 2021-12-02 | 株式会社ダイセル | 異常変調原因特定装置、異常変調原因特定方法及び異常変調原因特定プログラム |
DE102022208467A1 (de) | 2022-06-24 | 2024-01-04 | Bilfinger Life Science Gmbh | Modulare Vorrichtung und Verfahren zur kontinuierlichen Herstellung von biotechnologischen Produkten |
WO2023247798A1 (de) | 2022-06-24 | 2023-12-28 | Bilfinger Life Science Gmbh | Modulare vorrichtung und verfahren zur kontinuierlichen herstellung von biotechnologischen produkten |
Family Cites Families (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU5546594A (en) * | 1992-11-06 | 1994-06-08 | Abbott Laboratories | Process control system for biological fluid testing |
JP2004198123A (ja) * | 2002-12-16 | 2004-07-15 | Shimadzu Corp | 分取液体クロマトグラフ質量分析装置 |
JP3823092B2 (ja) * | 2003-03-11 | 2006-09-20 | 株式会社日立ハイテクノロジーズ | 分離分析装置 |
JP2006018711A (ja) * | 2004-07-05 | 2006-01-19 | Earekkusu:Kk | 液体除染剤供給システム |
PT2550971T (pt) | 2004-09-30 | 2017-10-02 | Bayer Healthcare Llc | Dispositivos e métodos para fabrico contínuo integrado de moléculas biológicas |
EP1882030B1 (en) * | 2005-05-09 | 2014-08-06 | ALPHA PLAN GmbH | Apparatus for providing media to cell culture modules |
WO2007109157A2 (en) * | 2006-03-17 | 2007-09-27 | Waters Investments Limited | Solvent delivery system for liquid chromatography that maintains fluid integrity and pre-forms gradients |
JP4831480B2 (ja) * | 2006-06-21 | 2011-12-07 | 三浦工業株式会社 | 膜濾過システム |
CN105842435B (zh) * | 2010-12-03 | 2019-03-05 | 塞普莱有限公司 | 细胞功能的微分析 |
EP2649016B1 (en) | 2010-12-06 | 2020-06-10 | Pall Corporation | Continuous processing methods for biological products |
CN103243026B (zh) * | 2012-02-14 | 2014-09-03 | 常州医凌生命科技有限公司 | 多功能全自动细胞及溶液处理仪 |
EP2682168A1 (en) * | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
WO2014112527A1 (ja) * | 2013-01-18 | 2014-07-24 | 株式会社島津製作所 | サンプル濃縮装置 |
SG10201709131UA (en) | 2013-03-08 | 2017-12-28 | Genzyme Corp | Continuous purification of therapeutic proteins |
DE102013212540A1 (de) * | 2013-06-27 | 2014-12-31 | Agilent Technologies Inc. | Konditionieren eines nachfolgenden Probenpakets in einer Probentrennstufe während Prozessierens eines vorangehenden Probenpakets in einer Probenweiterverarbeitungsstufe |
BR112017002083B1 (pt) * | 2014-07-31 | 2022-04-05 | Govind Rao | Sistema de bioprocessamento para a fabricação de proteína de sangue |
-
2015
- 2015-05-13 EP EP15167538.6A patent/EP3093335A1/de not_active Withdrawn
-
2016
- 2016-05-06 AR ARP160101310A patent/AR104554A1/es unknown
- 2016-05-10 CN CN201680040972.0A patent/CN107849506B/zh not_active Expired - Fee Related
- 2016-05-10 WO PCT/EP2016/060369 patent/WO2016180798A1/de active Application Filing
- 2016-05-10 ES ES16722163T patent/ES2760468T3/es active Active
- 2016-05-10 MX MX2017014527A patent/MX2017014527A/es unknown
- 2016-05-10 PT PT167221639T patent/PT3294856T/pt unknown
- 2016-05-10 PL PL16722163T patent/PL3294856T3/pl unknown
- 2016-05-10 SG SG11201709329YA patent/SG11201709329YA/en unknown
- 2016-05-10 EP EP16722163.9A patent/EP3294856B1/de active Active
- 2016-05-10 KR KR1020177035436A patent/KR20180005225A/ko not_active Application Discontinuation
- 2016-05-10 CA CA2985678A patent/CA2985678A1/en active Pending
- 2016-05-10 AU AU2016259746A patent/AU2016259746B2/en active Active
- 2016-05-10 RU RU2017143437A patent/RU2724495C2/ru active
- 2016-05-10 DK DK16722163T patent/DK3294856T3/da active
- 2016-05-10 US US15/573,148 patent/US20180127461A1/en not_active Abandoned
- 2016-05-10 BR BR112017024373-3A patent/BR112017024373B1/pt not_active IP Right Cessation
- 2016-05-10 JP JP2017559064A patent/JP6833721B2/ja active Active
- 2016-05-11 TW TW105114507A patent/TWI689303B/zh not_active IP Right Cessation
-
2017
- 2017-11-09 IL IL255556A patent/IL255556B/en unknown
- 2017-11-13 SA SA517390330A patent/SA517390330B1/ar unknown
- 2017-12-12 ZA ZA2017/08418A patent/ZA201708418B/en unknown
-
2018
- 2018-09-26 HK HK18112294.8A patent/HK1252939A1/zh unknown
-
2021
- 2021-03-04 US US17/192,384 patent/US20210221842A1/en not_active Abandoned
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