CN110791427A - General cell processing total station system - Google Patents
General cell processing total station system Download PDFInfo
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- CN110791427A CN110791427A CN201911021369.XA CN201911021369A CN110791427A CN 110791427 A CN110791427 A CN 110791427A CN 201911021369 A CN201911021369 A CN 201911021369A CN 110791427 A CN110791427 A CN 110791427A
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- 238000012545 processing Methods 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 claims abstract description 55
- 210000004027 cell Anatomy 0.000 claims abstract description 35
- 210000002865 immune cell Anatomy 0.000 claims abstract description 30
- 210000000130 stem cell Anatomy 0.000 claims abstract description 30
- 238000012546 transfer Methods 0.000 claims abstract description 13
- 238000001514 detection method Methods 0.000 claims abstract description 3
- 238000012258 culturing Methods 0.000 claims description 6
- 239000002184 metal Substances 0.000 claims description 6
- 239000002699 waste material Substances 0.000 claims description 6
- 238000007726 management method Methods 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 5
- 238000004891 communication Methods 0.000 claims description 2
- 238000005516 engineering process Methods 0.000 abstract description 13
- 238000000034 method Methods 0.000 abstract description 8
- 238000004519 manufacturing process Methods 0.000 abstract description 7
- 238000012544 monitoring process Methods 0.000 abstract description 5
- 238000002955 isolation Methods 0.000 abstract description 4
- 238000011165 process development Methods 0.000 abstract description 4
- ZOOGRGPOEVQQDX-UUOKFMHZSA-N 3',5'-cyclic GMP Chemical compound C([C@H]1O2)OP(O)(=O)O[C@H]1[C@@H](O)[C@@H]2N1C(N=C(NC2=O)N)=C2N=C1 ZOOGRGPOEVQQDX-UUOKFMHZSA-N 0.000 abstract description 3
- 238000011160 research Methods 0.000 abstract description 3
- 230000001954 sterilising effect Effects 0.000 abstract description 3
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 3
- 238000012423 maintenance Methods 0.000 abstract description 2
- 238000002659 cell therapy Methods 0.000 description 7
- 238000011112 process operation Methods 0.000 description 3
- 238000011194 good manufacturing practice Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 238000005057 refrigeration Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000009169 immunotherapy Methods 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 210000001503 joint Anatomy 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 238000012946 outsourcing Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000009168 stem cell therapy Methods 0.000 description 1
- 238000009580 stem-cell therapy Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/02—Form or structure of the vessel
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/52—Mobile; Means for transporting the apparatus
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/58—Reaction vessels connected in series or in parallel
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
- C12M41/12—Means for regulation, monitoring, measurement or control, e.g. flow regulation of temperature
- C12M41/18—Heat exchange systems, e.g. heat jackets or outer envelopes
- C12M41/22—Heat exchange systems, e.g. heat jackets or outer envelopes in contact with the bioreactor walls
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Abstract
The invention discloses a general cell processing total station system, which is characterized in that: comprises a stem cell preparation area, an immune cell preparation area, a transfer window, an RTP culture box, a transfer trolley and an electrical control cabinet for controlling the operation of detection equipment. The invention can simultaneously satisfy the stem cell preparation process operation and the immune cell preparation process operation, greatly improves the utilization rate of equipment, and has good universality, high utilization rate, good process development and strong traceability of process parameters; the whole cell preparation operation environment better meets the cGMP standard requirement by adopting an aseptic isolation technology, a VHP sterilization technology, an intelligent information control technology, an online environment monitoring technology and the like; the equipment use background environment level requirement is low, the clean cell production area is reduced, the controllability of the production area is greatly increased, the operation cost and the maintenance cost are further reduced, and the method is suitable for various large and small biological scientific research institutions, biological pharmaceutical factories and the like.
Description
Technical Field
The invention relates to a universal cell processing total station system, and belongs to the technical field of cell therapy.
Background
In recent 5 years, the therapeutic effects of stem cell therapy and immunotherapy have gradually become positive with the rise of cell therapy. The clinical application of Chinese cell therapy is continuously increased in two years because various foreign cell therapy products are approved to be on the market and the domestic cell therapy industry is in a state of fire-heat. 2017, the national food and drug administration organization sets out a whole process control system in the cell therapy product research and evaluation technology guide principle (trial) to avoid the raw materials for production and the possible introduction of exogenous pollution or cross pollution in the production operation process, and prevents the confusion of products from different suppliers or products in different batches due to the establishment of effective isolation measures; the european union committee in 2017 finally finalized the Good Manufacturing Practice (GMP) guidelines on innovative cell, gene and tissue therapies, also known as advanced therapeutic pharmaceutical products (ATMP), where it is mentioned that production in isolators or positive pressure isolators in closed systems is acceptable in the background of class D clean zones;
most of cell preparation equipment in the current market is individualized, and the advantages of equipment universality, process compatibility, flexible process development and the like are difficult to achieve simultaneously; therefore, in order to meet the market demand of the cell therapy industry and meet the national regulation requirements, a universal cell processing total station system device needs to be developed.
Disclosure of Invention
The technical problems to be solved by the invention are as follows: at present, part of cell preparation equipment in the market is difficult to realize the technical problems of equipment universality, process compatibility, flexible process development, process parameter traceability and the like:
in order to solve the technical problems, the technical scheme of the invention is to provide a general cell processing total station system, which is characterized in that: comprises a stem cell preparation area used for stem cell preparation process operation and an immune cell preparation area used for immune cell preparation process operation;
a delivery window for delivering samples and materials to the stem cell preparation area and/or the immune cell preparation area;
the transfer trolley is used for transporting the RTP incubator to an RTP incubator management system;
and the electrical control cabinet is used for storing electrical components and controlling the operation of the detection equipment.
Preferably, a first camera for observing the internal condition of the stem cell preparation area, a first microscope for observing the stem cells, a first RTP waste bag, a first metal bath module for controlling the temperature of the stem cell preparation area, a first integrated centrifuge and a first RTP incubator for culturing the prepared stem cells are arranged in the stem cell preparation area.
Preferably, the first microscope is an embedded microscope.
Preferably, a second camera for observing the internal condition of the immune cell preparation area, a second microscope for observing the immune cells, a second RTP waste bag, a second metal bath module for controlling the temperature of the immune cell preparation area, a second integrated centrifuge and a second RTP incubator for culturing the prepared immune cells are arranged in the immune cell preparation area.
Preferably, the second microscope is an embedded microscope.
Preferably, a human-computer communication interface is arranged on the electric control cabinet.
Preferably, a camera three for observing the sample and a code scanning gun for scanning the sample are arranged at the position of the delivery window.
Compared with the prior art, the invention has the beneficial effects that:
the invention discloses a universal cell processing total station system, which can simultaneously satisfy stem cell preparation process operation and immune cell preparation process operation and provide an ideal cell preparation process development platform for customers, thereby greatly improving the utilization rate of equipment. The equipment integrated information management and control system comprises a sample information acquisition function and a cell processing operation monitoring function, ensures the traceability of records, and has the advantages of good universality, high utilization rate, good process development and strong process parameter traceability.
The invention adopts the sterile isolation technology, the VHP sterilization technology, the intelligent information control technology, the online environment monitoring technology and the like, so that the whole cell preparation operation environment better meets the cGMP standard requirement; in addition, the environment of the cell preparation area is completely isolated from the external environment, so that the risk of the cell sample being polluted by the external environment is reduced; and the requirement on the use background environment grade of the equipment is low, so that the clean cell production area is reduced, the controllability of the production area is greatly increased, the operation cost and the maintenance cost are further reduced, and the method is suitable for various large and small biological scientific research institutions, biological pharmaceutical factories and the like.
Drawings
FIG. 1 is a front view of a universal cell processing total station system of the present invention;
FIG. 2 is a top view of a universal cell processing total station system of the present invention;
FIG. 3 is a front view of an electrical control cabinet in the universal cell processing total station system of the present invention;
FIG. 4 is a front view of a stem cell preparation area in the universal cell processing total station system of the present invention;
FIG. 5 is a front view of a delivery window in the universal cell processing total station system of the present invention;
FIG. 6 is a front view of an immune cell preparation area in the universal cell processing total station system of the present invention;
FIG. 7 is a front view of a transfer cart in the universal cell processing total station system of the present invention.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings.
As shown in fig. 1 and fig. 2, the universal cell processing total station system of the present invention mainly includes an electrical cabinet 10, a stem cell preparation area 20, a delivery window 30, an immune cell preparation area 40, and a transfer cart 60. The electrical cabinet 10 is mainly used for storing electrical components and controlling and detecting the operation of equipment; the stem cell preparation area 20 is mainly used for the process operation of stem cell preparation; the transfer window 30 is mainly used for the in-and-out transfer of samples and materials, and the materials can be transferred to the stem cell preparation area 20 through the transfer window 30 and also can be transferred to the immune cell preparation area 40; the immune cell preparation area 40 is mainly used for the technological operation of immune cell preparation; the RTP incubator 50 is mainly used for incubation culture of the prepared cells, and can realize rapid sterile butt joint of the incubator and the isolator after being matched with an RTP valve for use; the transfer trolley 60 is mainly used for transferring the RTP incubator to an incubator management system; as shown in fig. 3, the electrical cabinet 10 mainly stores electrical components, and controls and detects the operation of equipment; the human-computer interface 11 can set equipment parameters and control the starting and stopping of the equipment, and can also check the collected sample information and the monitoring video of the cell processing operation of each batch; as shown in FIG. 4, the stem cell preparation area 20 is mainly used for the process operation of stem cell preparation, and its main components include: the system comprises a RTP waste bag (23), an integrated centrifuge (25), an embedded microscope (22) for observing stem cells, a metal bath module (24) integrating refrigeration and heating and used for controlling the temperature of a stem cell preparation area (20), a camera (21) for observing the internal condition of the stem cell preparation area (20) and an RTP incubator (50) for culturing the prepared stem cells; as shown in fig. 5, the transfer window 30 is mainly used for transferring the sample and the material in and out, and the main components thereof include: a camera three 31 and a code scanning gun 32; before the sample is placed in the delivery window 30, a bar code (or a two-dimensional code) on the outsourcing of the sample is scanned by a bar code scanning gun 32, and the system stores the basic information of the current user and the name and operation time information of an operator; as shown in fig. 6, the immune cell preparation area 40 is mainly used for the process operation of immune cell preparation, and its main components include: a second RTP waste bag 42, a second integrated centrifuge 44, a second embedded microscope 45 for observing immune cells, a second metal bath module 43 integrating refrigeration and heating and used for controlling the temperature of the immune cell preparation area 40, a second camera 41 for observing the internal condition of the immune cell preparation area 40 and a second RTP incubator 51 for culturing the prepared immune cells; as shown in fig. 7, the transfer cart 60 is primarily used to transfer RTP incubators 50 to an incubator management system.
The invention adopts the sterile isolation technology, the VHP sterilization technology, the intelligent information control technology, the online environment monitoring technology and the like, so that the whole cell preparation operation environment better meets the cGMP standard requirement.
Claims (7)
1. A universal cell processing total station system, comprising: comprises a stem cell preparation area (20) used for stem cell preparation process operation, an immune cell preparation area (40) used for immune cell preparation process operation;
a delivery window (30) for delivering sample and material to the stem cell preparation area (20) and/or the immune cell preparation area (40);
a transfer cart (60) for transporting the RTP incubator (50) to an RTP incubator management system;
and the electrical control cabinet (10) is used for storing electrical components and controlling the operation of the detection equipment.
2. The universal cell processing total station system according to claim 1, wherein: the stem cell preparation area (20) is internally provided with a first camera (21) for observing the internal condition of the stem cell preparation area (20), a first microscope (21) for observing stem cells, a first RTP waste bag (23), a first metal bath module (24) for controlling the temperature of the stem cell preparation area (20), a first integrated centrifuge (25) and a first RTP incubator (50) for culturing the prepared stem cells.
3. A universal cell processing total station system according to claim 2, wherein: the first microscope is an embedded microscope (22).
4. The universal cell processing total station system according to claim 1, wherein: the immune cell preparation area (40) is internally provided with a second camera (41) for observing the internal condition of the immune cell preparation area (40), a second microscope (45) for observing immune cells, a second RTP waste bag (42), a second metal bath module (43) for controlling the temperature of the immune cell preparation area (40), a second integrated centrifuge (44) and a second RTP incubator (51) for culturing the prepared immune cells.
5. The universal cell processing total station system according to claim 4, wherein: the second microscope is an embedded microscope II (45).
6. The universal cell processing total station system according to claim 1, wherein: and a man-machine communication interface (11) is arranged on the electrical control cabinet (10).
7. The universal cell processing total station system according to claim 1, wherein: and a camera III (31) for observing the sample and a code scanning gun (32) for scanning the sample are arranged at the position of the delivery window (30).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911021369.XA CN110791427A (en) | 2019-10-25 | 2019-10-25 | General cell processing total station system |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911021369.XA CN110791427A (en) | 2019-10-25 | 2019-10-25 | General cell processing total station system |
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| CN110791427A true CN110791427A (en) | 2020-02-14 |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106507801B (en) * | 2004-05-12 | 2006-07-05 | 中国航天员科研训练中心 | Full-automatic spatial cell biological study experiment porch |
| WO2010086465A1 (en) * | 2009-01-30 | 2010-08-05 | Emilio Mateu Sentamans | Method and modular equipment for the processing and storage of cell cultures |
| WO2014155500A1 (en) * | 2013-03-25 | 2014-10-02 | 株式会社日立製作所 | Cell culturing device, culturing vessel, and holding vessel |
| CN204779581U (en) * | 2015-06-01 | 2015-11-18 | 沈阳澔源生物科技有限公司 | Aseptic detection adapter of cell culture |
| CN107828650A (en) * | 2017-09-21 | 2018-03-23 | 浙江泰林生物技术股份有限公司 | A kind of cellular immunotherapy work station |
| CN108353891A (en) * | 2018-03-23 | 2018-08-03 | 成都吱吖科技有限公司 | A kind of efficient candidate stem cell freezes transhipment kit |
| CN207738760U (en) * | 2017-12-19 | 2018-08-17 | 上海东富龙医疗装备有限公司 | A kind of cell processing whole station system |
-
2019
- 2019-10-25 CN CN201911021369.XA patent/CN110791427A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106507801B (en) * | 2004-05-12 | 2006-07-05 | 中国航天员科研训练中心 | Full-automatic spatial cell biological study experiment porch |
| WO2010086465A1 (en) * | 2009-01-30 | 2010-08-05 | Emilio Mateu Sentamans | Method and modular equipment for the processing and storage of cell cultures |
| WO2014155500A1 (en) * | 2013-03-25 | 2014-10-02 | 株式会社日立製作所 | Cell culturing device, culturing vessel, and holding vessel |
| CN204779581U (en) * | 2015-06-01 | 2015-11-18 | 沈阳澔源生物科技有限公司 | Aseptic detection adapter of cell culture |
| CN107828650A (en) * | 2017-09-21 | 2018-03-23 | 浙江泰林生物技术股份有限公司 | A kind of cellular immunotherapy work station |
| CN207738760U (en) * | 2017-12-19 | 2018-08-17 | 上海东富龙医疗装备有限公司 | A kind of cell processing whole station system |
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Non-Patent Citations (1)
| Title |
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