CN110643508A - Modular automatic cell culture system and method - Google Patents
Modular automatic cell culture system and method Download PDFInfo
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- CN110643508A CN110643508A CN201810665913.3A CN201810665913A CN110643508A CN 110643508 A CN110643508 A CN 110643508A CN 201810665913 A CN201810665913 A CN 201810665913A CN 110643508 A CN110643508 A CN 110643508A
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- 238000000034 method Methods 0.000 title claims abstract description 45
- 238000004113 cell culture Methods 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 claims abstract description 65
- 238000004519 manufacturing process Methods 0.000 claims abstract description 52
- 238000001514 detection method Methods 0.000 claims abstract description 41
- 238000005138 cryopreservation Methods 0.000 claims abstract description 18
- 238000007710 freezing Methods 0.000 claims abstract description 8
- 230000008014 freezing Effects 0.000 claims abstract description 8
- 238000013439 planning Methods 0.000 claims abstract description 8
- 230000007774 longterm Effects 0.000 claims abstract description 5
- 230000008569 process Effects 0.000 claims description 28
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- 238000012258 culturing Methods 0.000 claims description 6
- 238000007726 management method Methods 0.000 abstract description 13
- 238000010276 construction Methods 0.000 abstract description 11
- 230000008901 benefit Effects 0.000 abstract description 9
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- 229940079593 drug Drugs 0.000 description 6
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- 238000002659 cell therapy Methods 0.000 description 2
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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
- C12M41/48—Automatic or computerized control
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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
- C12M1/00—Apparatus for enzymology or microbiology
- C12M1/36—Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
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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
- C12M3/00—Tissue, human, animal or plant cell, or virus culture apparatus
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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
- C12M3/00—Tissue, human, animal or plant cell, or virus culture apparatus
- C12M3/06—Tissue, human, animal or plant cell, or virus culture apparatus with filtration, ultrafiltration, inverse osmosis or dialysis means
Abstract
The invention relates to a modularized automatic cell culture system and a method, wherein the system comprises a cell preparation unit, a quality detection unit and a cell cryopreservation unit; a cell preparation unit for separating and sorting target cells and purifying the target cells before production; the cell preparation unit is used for preparing cells and carrying out daily production quality detection; the quality detection unit is used for completely detecting the prepared cells before reinjection of the patient; and the cell freezing and storing unit is used for short-term or long-term freezing and storing the cells. According to the invention, cell preparation, quality detection and cell cryopreservation are divided into modules, the modules are integrated to form a structure, the modules are connected through a standard connection expansion interface, and a server is used for data recording and daily operation planning and management of each unit, so that modularization of a cell culture process is realized, facility construction cost is reduced, cells are automatically cultured, and effective cost optimization, industrial scale expansion and economic benefits brought by large-scale cell production are formed.
Description
Technical Field
The invention relates to a cell culture method, in particular to a modular automatic cell culture system and a method.
Background
The clinical curative effect of cell therapy is verified, policies at home and abroad greatly support the development of related industries, and the industries develop tuyeres, so that great demands are provided for large-scale cell preparation.
At present, cell preparation at home and abroad is still mainly a manual production mode, when capacity is expanded in a large scale, industrial investment is hard to bear due to a large amount of personnel cost, a large amount of personnel training cost, large-area high-cleanliness facility construction cost, high certification cost of new facilities and the like, and meanwhile, the quality caused by manual preparation is unstable and inhomogeneous, and the requirements of high quality and safety of cell therapy are hard to meet. The manual operation of the semi-automatic equipment can only carry out production and preparation for a single patient in the same time period, the benefits brought by the realization of the industrialized cell production scale and the effective reduction of the preparation and production cost are limited, the use cost is high, the existing semi-automatic equipment is generally customized and researched based on a specific production process, the adaptability and expansibility requirements of different production processes of different cell treatment schemes are difficult to meet, the quality and quality control of the later-stage large-scale production is difficult to provide systematic production and quality control data, although the production efficiency is improved, the existing semi-automatic equipment still needs a large amount of manual operation and still requires the construction of a high-grade purification room environment, in addition, before the cells are subjected to large-scale preparation and production, the process operations such as separation, cleaning and purification of target cells are required, and important nodes are generated after the cells are prepared and in the production process, the cell product is required to be reserved and released for detection, a planned injection window is required to be observed before the cell product is reinjected into a patient, the cryopreservation of a cell finished product is generally required, based on the existing production and business modes, the operation of each relevant step is distributed in different places, a large amount of special factory building facility construction and personnel training are required in the operation process, the product pollution and the quality fluctuation are caused by the operation and the transportation in the production, inspection and storage processes, and the delivery cycle of a final product is prolonged.
Therefore, there is a need to design a new automatic cell culture system, which realizes modularization of cell culture process, reduces facility construction cost, automatically cultures cells, and forms effective cost optimization, industrial scale expansion and economic benefits brought by large-scale cell production.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a modular automatic cell culture system and a method.
In order to achieve the purpose, the invention adopts the following technical scheme: a modular automatic cell culture system comprises a cell preparation unit, a quality detection unit and a cell cryopreservation unit;
the cell preparation unit is used for separating and sorting target cells and purifying the target cells before production;
the cell preparation unit is used for preparing cells and performing daily production quality detection;
the quality detection unit is used for complete detection of the prepared cells before reinjection into the patient;
the cell freezing and storing unit is used for short-term or long-term freezing and storing cells.
The further technical scheme is as follows: the cell preparation unit also comprises a standard preparation module and a customization module;
the standard preparation module is used for preparing cells according to a standard cell culture mode;
the customization module is used for preparing cells according to different process requirements.
The further technical scheme is as follows: the system comprises a server, wherein the server is used for daily operation planning and management of a cell preparation unit, a quality detection unit and a cell cryopreservation unit, and data collection, storage, analysis and transmission of the preparation process.
The further technical scheme is as follows: and a data center is arranged in the server and used for recording all-node data.
The invention also provides a modular automatic cell culture method, which comprises the following steps:
purifying and separating the cells;
culturing the separated cells;
the prepared cells were tested intact prior to patient reinjection.
The further technical scheme is as follows: the method further comprises the following steps:
cells are stored frozen for short or long periods of time.
The further technical scheme is as follows: the step of culturing the separated cells comprises the following specific steps:
acquiring the requirement of a culture process;
judging whether the culture process requirement is a standard process requirement;
if yes, preparing cells according to a standard cell culture mode;
if not, preparing the cells according to different process requirements.
The further technical scheme is as follows: the prepared cells are subjected to complete detection before reinjection of a patient, and the complete detection comprises basic release detection and special release detection of the cells.
Compared with the prior art, the invention has the beneficial effects that: according to the modularized automatic cell culture system, cell preparation, quality detection and cell cryopreservation are divided into modules, the modules are integrated to form a structure, the modules are connected through standard connection expansion interfaces, data recording and daily operation planning and management of each unit are performed by using a server, modularization of a cell culture process is achieved, facility construction cost is reduced, cells are cultured automatically, and effective cost optimization, industrial scale expansion and economic benefits brought by large-scale cell production are achieved.
The invention is further described below with reference to the accompanying drawings and specific embodiments.
Drawings
FIG. 1 is a block diagram of a modular cell culture system according to an embodiment of the present invention;
FIG. 2 is a block flow diagram of a modular cell culture method according to an embodiment of the present invention.
Detailed Description
In order to more fully understand the technical content of the present invention, the technical solution of the present invention will be further described and illustrated with reference to the following specific embodiments, but not limited thereto.
As shown in fig. 1-2, the present embodiment provides a modular automatic cell culture system, which can be applied to a cell culture process to perform modular culture, so as to modularize the cell culture process, reduce the facility construction cost, automatically culture cells, and form effective cost optimization, industrial scale expansion and economic benefits due to large-scale cell production.
As shown in FIG. 1, the present embodiment provides a modular automatic cell culture system, which includes a cell preparation unit 1, a cell preparation unit 2, a quality detection unit 3, and a cell cryopreservation unit 4.
The cell preparation unit 1 is used for separation and sorting of target cells and purification before production.
And the cell preparation unit 2 is used for preparing cells and performing daily production quality detection.
And the quality detection unit 3 is used for completely detecting the prepared cells before reinjection into the patient.
And the cell freezing and storing unit 4 is used for short-term or long-term freezing and storing the cells.
For the cell preparation unit 1, particularly, according to different cell process requirements, devices for separating, purifying and detecting different types of cells are integrated, and a standard connection expansion interface is arranged on the cell preparation unit 1, so that modules can be conveniently connected.
The cell preparation unit 2 for the above also includes a standard preparation module and a customization module.
And a standard preparation module for preparing cells according to a standard cell culture mode.
And the customization module is used for preparing cells according to different process requirements.
For the standard preparation module, basic necessary functions of each process are integrated, and the customized module is formed by integrating special equipment according to different process requirements.
The production functions in the cell preparation unit 2 are highly modularized, a standard platform unit, a special process unit, standardized software and hardware and a mechanical structure are configured, continuous expansion can be realized according to requirements, a fully-closed system and automatic sterilization and disinfection are realized, and the detection function in the basic production process is integrated.
The quality detection unit 3 includes a standard quality detection management module and a configurable quality detection management module, and highly modularizes the cell detection function, and basically releases the cell product for detection and specially releases the cell product for detection.
In addition, the system comprises a server 5, and the server 5 is used for daily operation planning and management of the cell preparation unit 1, the cell preparation unit 2, the quality detection unit 3 and the cell cryopreservation unit 4, and data collection, storage, analysis and transmission of the preparation process.
Specifically, a data center is provided in the server 5, and is used for recording all-node data.
The system provides complete integration and optimization of the whole flow of each main production process step of cell preparation, cell preparation, quality detection in the cell preparation process, cell preparation release quality detection, cell cryopreservation and the like; providing a basic hardware and software platform, defining a production process flow by a client, ensuring the production knock-how of the client and the core IP of the client, and solving the core IP leakage risk of the client; the unmanned production can be realized by matching with factory management software; a compact solution is formed, a complete cell factory can be built within 200 square meters, the capacity scale which can be realized only by facilities with the length of more than 1000 square meters in the traditional mode is reached, the facility construction cost is greatly reduced, and system operation management personnel are one tenth or lower than those in the traditional mode; the method provides data definition, collection, storage, analysis and transmission of a full-flow production node and a quality detection node from cell preparation to cell product packaging cryopreservation, effectively assists development of customer cell medicines, improves production process stably, facilitates integrated certification and registration of the customer cell medicines, has unified data record and excellent traceability, facilitates certification, registration and audit and daily supervision of a supervision organization on the cell medicines, facilitates cell medicine production clients to efficiently expand capacity after passing the audit, enables a brand new mode of industrial scale cell preparation production and distributed cell production service to become possible, and meets the requirement of the industry; interference caused by human and environmental factors in the preparation and production process is eliminated, the uniformity of the product is effectively improved, and the influence of environmental pollution is effectively reduced; artificial data operation errors are effectively avoided, the leakage risk of core preparation intellectual property caused by personnel flow is reduced, and high cost caused by repeated personnel training is greatly reduced; the system realizes full-automatic and full-flow data collection and management, accelerates data collection analysis and scheme decision in the research and development process, and effectively improves the auditing management of a supervision mechanism on the production flow and the quality of a final product; the method is convenient for the copying and expansion of the service of the equipment user in the global range, and forms the scale benefit of the whole industry.
For the modularized automatic cell culture system, cell preparation, quality detection and cell cryopreservation are divided into modules, the modules are integrated to form a structure, the modules are connected through standard connection expansion interfaces, data recording and daily operation planning and management of each unit are performed by using the server 5, modularization of the cell culture process is achieved, facility construction cost is reduced, cells are cultured automatically, and effective cost optimization, industrial scale expansion and economic benefits brought by large-scale cell production are achieved.
As shown in fig. 2, the present embodiment further provides a modular cell culture method, which includes:
s1, purifying and separating the cells;
s2, culturing the separated cells;
s3, the prepared cells are completely detected before reinjection of the patient.
In addition, the method further comprises:
s4, performing short-term or long-term cryopreservation of the cells.
For the step S1, the device for separating, purifying and detecting different kinds of cells is integrated according to different cell process requirements, and the cells are purified, separated and sorted.
Further, the step of culturing the isolated cells in the step of S2 includes the following steps:
s21, obtaining the requirement of the culture process;
s22, judging whether the culture process requirement is a standard process requirement;
s23, if yes, preparing cells according to a standard cell culture mode;
and S24, if not, preparing the cells according to different process requirements.
The cell is prepared according to a standard cell culture mode, basic necessary functions of each process are integrated, and the cell preparation according to different process requirements is specifically realized by integrating special equipment according to different process requirements to form a configurable module.
The production functions in the cell preparation process are highly modularized, a standard platform unit, a special process unit, standardized software, hardware and mechanical structures are formed in a configuration mode, continuous expansion can be achieved according to requirements, a fully-closed system and automatic sterilization and disinfection are achieved, and the detection function in the basic production process is integrated.
In addition, with respect to step S3 described above, the step of performing a complete test of the prepared cells before the patient is reinjected, including a basic release test and a special release test of the cells, makes the cell testing function highly modular.
Further, in some embodiments, the method further comprises:
preparation before cell preparation, cell preparation and quality detection, daily operation planning and management of cell cryopreservation, and data collection, storage, analysis and transmission in the preparation process.
The method further comprises the following steps: and recording the data of the whole nodes.
The method provides complete integration and optimization of the whole flow of each main production process step of cell preparation, cell preparation, quality detection in the cell preparation process, cell preparation release quality detection, cell cryopreservation and the like; providing a basic hardware and software platform, defining a production process flow by a client, ensuring the production knock-how of the client and the core IP of the client, and solving the core IP leakage risk of the client; the unmanned production can be realized by matching with factory management software; a compact solution is formed, a complete cell factory can be built within 200 square meters, the capacity scale which can be realized only by facilities with the length of more than 1000 square meters in the traditional mode is reached, the facility construction cost is greatly reduced, and system operation management personnel are one tenth or lower than those in the traditional mode; the method provides data definition, collection, storage, analysis and transmission of a full-flow production node and a quality detection node from cell preparation to cell product packaging cryopreservation, effectively assists development of customer cell medicines, improves production process stably, facilitates integrated certification and registration of the customer cell medicines, has unified data record and excellent traceability, facilitates certification, registration and audit and daily supervision of a supervision organization on the cell medicines, facilitates cell medicine production clients to efficiently expand capacity after passing the audit, enables a brand new mode of industrial scale cell preparation production and distributed cell production service to become possible, and meets the requirement of the industry; interference caused by human and environmental factors in the preparation and production process is eliminated, the uniformity of the product is effectively improved, and the influence of environmental pollution is effectively reduced; artificial data operation errors are effectively avoided, the leakage risk of core preparation intellectual property caused by personnel flow is reduced, and high cost caused by repeated personnel training is greatly reduced; the system realizes full-automatic and full-flow data collection and management, accelerates data collection analysis and scheme decision in the research and development process, and effectively improves the auditing management of a supervision mechanism on the production flow and the quality of a final product; the method is convenient for the copying and expansion of the service of the equipment user in the global range, and forms the scale benefit of the whole industry.
For the modularized automatic cell culture method, cell preparation, quality detection and cell cryopreservation are divided into modules, integrated to form a structure, connected through a standard connection expansion interface, and data recording, daily operation planning and management of each unit are performed by using the server 5, so that modularization of the cell culture process is realized, facility construction cost is reduced, cells are automatically cultured, and effective cost optimization, industrial scale expansion and economic benefits brought by large-scale cell production are formed.
The technical contents of the present invention are further illustrated by the examples only for the convenience of the reader, but the embodiments of the present invention are not limited thereto, and any technical extension or re-creation based on the present invention is protected by the present invention. The protection scope of the invention is subject to the claims.
Claims (8)
1. A modular automatic cell culture system is characterized by comprising a cell preparation unit, a quality detection unit and a cell cryopreservation unit;
the cell preparation unit is used for separating and sorting target cells and purifying the target cells before production;
the cell preparation unit is used for preparing cells and performing daily production quality detection;
the quality detection unit is used for complete detection of the prepared cells before reinjection into the patient;
the cell freezing and storing unit is used for short-term or long-term freezing and storing cells.
2. The system of claim 1, wherein the cell preparation unit further comprises a standard preparation module and a customization module;
the standard preparation module is used for preparing cells according to a standard cell culture mode;
the customization module is used for preparing cells according to different process requirements.
3. The system of claim 1 or 2, wherein the system comprises a server for planning and managing daily operations of the cell preparation unit, the quality detection unit and the cell cryopreservation unit, and collecting, storing, analyzing and transmitting data of the preparation process.
4. The system of claim 3, wherein a data center is provided in the server for recording full node data.
5. A modular cell culture method, comprising:
purifying and separating the cells;
culturing the separated cells;
the prepared cells were tested intact prior to patient reinjection.
6. The method of claim 5, further comprising:
cells are stored frozen for short or long periods of time.
7. The method for modular cell culture according to claim 6, wherein the step of culturing the separated cells comprises the following specific steps:
acquiring the requirement of a culture process;
judging whether the culture process requirement is a standard process requirement;
if yes, preparing cells according to a standard cell culture mode;
if not, preparing the cells according to different process requirements.
8. The method of claim 7, wherein the step of performing a complete test on the prepared cells before the reinjection into the patient comprises a basic release test and a special release test on the cells.
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| CN201810665913.3A CN110643508A (en) | 2018-06-26 | 2018-06-26 | Modular automatic cell culture system and method |
| PCT/CN2018/096119 WO2020000535A1 (en) | 2018-06-26 | 2018-07-18 | Modular automatic cell culture system and method |
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| CN201810665913.3A CN110643508A (en) | 2018-06-26 | 2018-06-26 | Modular automatic cell culture system and method |
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- 2018-06-26 CN CN201810665913.3A patent/CN110643508A/en active Pending
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