Quality control method and platform for mesenchymal stem cell preparation

Abstract

The invention discloses a quality control method and platform for mesenchymal stem cell preparation, and relates to the technical field of quality control, and the method comprises the following steps: obtaining material basic information based on a target donor; a preparation operation process is generated and divided into M cell preparation procedures, and key biological parameter marking is carried out on the procedures. A donor health condition is taken as a starting point, a cell growth characteristic tracking chain is set based on M processes, and a cell characterization simulation model is established in homogeneity indexes marked by key biological parameters. An abnormal cell population is marked based on the model, and a quality control cycle is set to optimize the stability of the mesenchymal stem cells and reduce the residual quantity, so that cell preparation management is performed. The technical problems that in the prior art, the preparation process of the mesenchymal stem cells lacks comprehensive donor evaluation, and abnormal cells cannot be effectively treated are solved, and the technical effect of improving the preparation safety and quality stability of the mesenchymal stem cells is achieved.

Description

Technical Field

[0001] The present application relates to the field of quality control technology, and in particular to a quality control method and platform for the preparation of mesenchymal stem cells. Background Art

[0002] In the scenario of mesenchymal stem cell preparation, the quality problem of cell preparation is particularly prominent, and the contradiction in the demand for quality control is also more prominent. Achieving effective quality control and better ensuring the quality of mesenchymal stem cells have become crucial links in the preparation of mesenchymal stem cells. Traditional quality control of mesenchymal stem cell preparation is often one-sided and imprecise. It may only focus on some indicators or links, and the evaluation of donor materials is not comprehensive. There is a lack of fine management of the cell preparation process. It is difficult to track and regulate the cell growth process in real time. Abnormal cells are not handled in a timely and systematic manner. There is a lack of in-depth analysis and utilization of key biological parameters. It is difficult to fully and accurately control the quality risk status of cell preparation. There are unreasonable situations in the allocation of quality control resources, resulting in poor quality control effects. The formulation of quality control plans is relatively simple and fixed, and cannot cope well with various changes in the process of mesenchymal stem cell preparation.

[0003] At present, relevant technologies lack comprehensive donor evaluation in the mesenchymal stem cell preparation process and cannot effectively handle abnormal cells. Summary of the invention

[0004] This application provides a quality control method and platform for the preparation of mesenchymal stem cells, and adopts a method based on the target donor to obtain basic information of materials including pathogen screening information, cell activity information and donor health status. According to the confirmation information of the cell preparation device, the preparation operation process is generated and divided into M cell preparation processes, and key biological parameter marking (including N uniformity indicators) is performed on these processes under a standard operating environment. Starting from the health status of the donor, a cell growth characteristic tracking chain is set based on M processes, and a cell characterization simulation model is established in the uniformity indicators marked with key biological parameters using the tracking chain, pathogen screening information, and cell activity information. Based on this model, abnormal cell populations are marked and a quality control cycle is set to optimize the stability of mesenchymal stem cells and reduce the residual amount, and the quality control strategy is determined to bind to the target donor for cell preparation management, which realizes the technical effect of improving the safety and quality stability of mesenchymal stem cell preparation by comprehensively evaluating the donor materials, finely managing the preparation process, tracking cell growth in real time, and effectively handling abnormal cells.

[0005] The present application provides a quality control method for preparing mesenchymal stem cells, including:

[0006] Based on the target donor, basic material information is obtained, and the basic material information includes pathogen screening information, cell activity information, and donor health status; according to the cell preparation device, synchronous operation confirmation information and performance confirmation information are generated, and a preparation operation process is generated to split and obtain M cell preparation processes; according to the preparation operation process, under a standard operating environment, key biological parameter markings are performed on the M cell preparation processes, and the key biological parameter markings include N different uniformity indicators; based on the M cell preparation processes, taking the donor health status in the basic material information as the starting point, multiple cell growth characteristic tracking chains are set, and the cell growth characteristic tracking chains are The tracking chain is obtained by cell growth and proliferation; among the N different uniformity indicators corresponding to the key biological parameter markers, based on the pathogen screening information and cell activity information in the basic information of the material, the multiple cell growth characteristic tracking chains are used to establish a cell characterization simulation model; based on the cell characterization simulation model, abnormal cell populations in the cell culture process are marked, and a quality control cycle is set for the abnormal cell populations. The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, and the quality control strategy of mesenchymal stem cells is determined, and the target donor is bound to perform cell preparation management of mesenchymal stem cells.

[0007] This application also provides a quality control platform for mesenchymal stem cell preparation, including:

[0008] A material basic information acquisition module, the material basic information acquisition module is used to acquire the material basic information based on the target donor, the material basic information includes pathogen screening information, cell activity information, and donor health status; a preparation operation process generation module, the preparation operation process generation module is used to synchronize the operation confirmation information and performance confirmation information according to the cell preparation device, and generate a preparation operation process, and split and acquire M cell preparation processes; a biological parameter labeling module, the biological parameter labeling module is used to label the M cell preparation processes with key biological parameters under a standard operating environment according to the preparation operation process, and the key biological parameter labels include N different uniformity indicators; a growth characteristic tracking chain setting module, the growth characteristic tracking chain setting module is used to set the growth characteristic tracking chain based on the M cell preparation processes, taking the donor health status in the material basic information as the starting point. A plurality of cell growth characteristic tracking chains are set, and the cell growth characteristic tracking chains are obtained by cell growth and proliferation; a cell characterization simulation model establishment module, the cell characterization simulation model establishment module is used to establish a cell characterization simulation model by using the plurality of cell growth characteristic tracking chains among N different uniformity indicators corresponding to the key biological parameter markers, based on the pathogen screening information and cell activity information in the material basic information; a quality control strategy determination module, the quality control strategy determination module is used to mark abnormal cell populations in the cell culture process based on the cell characterization simulation model, and set a quality control cycle for the abnormal cell population, the quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, determines the quality control strategy of mesenchymal stem cells, and binds with the target donor to perform cell preparation management of mesenchymal stem cells.

[0009] The quality control method and platform for mesenchymal stem cell preparation proposed in this application is first obtained based on the target donor, including pathogen screening information, cell activity information and basic material information of the donor's health status. According to the confirmation information of the cell preparation device, the preparation operation process is generated and divided into M cell preparation processes, and these processes are marked with key biological parameters (including N uniformity indicators) under the standard operating environment. Starting from the health status of the donor, a cell growth characteristic tracking chain is set based on M processes, and a cell characterization simulation model is established in the uniformity indicators marked with key biological parameters using the tracking chain and pathogen screening information and cell activity information. Based on this model, abnormal cell populations are marked and a quality control cycle is set to optimize the stability of mesenchymal stem cells and reduce the residual amount, and the quality control strategy is determined to bind to the target donor for cell preparation management, so as to achieve the technical effect of improving the safety and quality stability of mesenchymal stem cell preparation by comprehensively evaluating the donor material, finely managing the preparation process, tracking cell growth in real time and effectively handling abnormal cells. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the accompanying drawings of the embodiment of the present invention will be briefly introduced below. A flow chart is used in this application to illustrate the operations performed by the platform according to the embodiment of the present application. It should be understood that the previous or following operations are not necessarily performed precisely in order. On the contrary, various steps can be processed in reverse order or simultaneously as needed. At the same time, other operations can also be added to these processes, or one or more operations can be removed from these processes.

[0011] Figure 1 A schematic diagram of a quality control method for preparing mesenchymal stem cells provided in an embodiment of the present application;

[0012] Figure 2 This is a schematic diagram of the structure of a quality control platform for mesenchymal stem cell preparation provided in an embodiment of the present application.

[0013] Explanation of the reference numerals: basic material information acquisition module 10, preparation operation process generation module 20, biological parameter labeling module 30, growth characteristic tracking chain setting module 40, cell characterization simulation model establishment module 50, quality control strategy determination module 60. DETAILED DESCRIPTION

[0014] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application, it can be implemented in accordance with the contents of the specification. In order to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are listed below.

[0015] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings. The described embodiments should not be regarded as limiting the present application. All other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of this application.

[0016] In the following description, reference is made to "some embodiments", which describe a subset of all possible embodiments, but it is understood that "some embodiments" may be the same subset or different subsets of all possible embodiments, and may be combined with each other without conflict, and the terms "first\second" involved are merely to distinguish similar objects and do not represent a specific ordering of objects. The terms "including" and "having" and any variations are intended to cover non-exclusive inclusions, for example, a process, method, platform, product, or server that includes a series of steps or units is not necessarily limited to those steps or units that are clearly listed, but may include other steps or modules that are not clearly listed or inherent to these processes, methods, products, or devices. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by technicians in the technical field of this application. The terms used herein are for the purpose of describing the embodiments of the present application only.

[0017] The present application provides a quality control method and platform for preparing mesenchymal stem cells, such as Figure 1 As shown, the method includes:

[0018] Step S100, based on the target donor, obtain basic material information, which includes pathogen screening information, cell activity information, and donor health status. Specifically, in the quality control plan for mesenchymal stem cell preparation, the target donor is first determined, and then a comprehensive pathogen screening is performed on the target donor, including the detection of various viruses, bacteria, fungi, etc., and the screening results are recorded; at the same time, the metabolic activity and proliferation capacity of the donor cells are evaluated to obtain cell activity information; and the donor health status information is obtained through medical history surveys, physical examinations, and lifestyle assessments, and is recorded in detail. These basic material information, including pathogen screening information, cell activity information, and donor health status, will provide key data support for subsequent cell preparation processes, quality control model establishment, and strategy formulation to ensure the quality and safety of mesenchymal stem cell preparation.

[0019] Step S200, according to the cell preparation device, synchronize the operation confirmation information and performance confirmation information, generate the preparation operation process, and split and obtain M cell preparation processes. Specifically, in the quality control scheme for mesenchymal stem cell preparation, the cell preparation device is first checked for synchronized operation confirmation information and performance confirmation information. Confirmation includes operation confirmations such as checking power connection, control system startup, sensor operation, normal communication module, and performance confirmations such as testing temperature control, evaluating stirring or oscillation, checking the filtration system, and verifying sterility. Then, based on the confirmed device information, combined with professional knowledge and experience, a detailed preparation operation process is formulated and recorded in writing, and a flow chart or operation manual can be made. Then the generated operation process is carefully analyzed and split into multiple independent cell preparation processes, such as cell collection, culture, purification, amplification, harvesting and storage, and the key parameters and quality indicators of each process are determined to provide guidance and specifications for the high-quality preparation of mesenchymal stem cells.

[0020] Step S300, according to the preparation operation process, under the standard operating environment, the M cell preparation processes are marked with key biological parameters, and the key biological parameter marking includes N different uniformity indicators. Specifically, in the quality control plan for the preparation of mesenchymal stem cells, the generated preparation operation process is first clarified, covering the links of cell collection, culture, purification, amplification, harvesting and storage. Then a standard operating environment is established, parameters such as temperature, humidity, and air pressure are controlled, aseptic operation specifications are strictly implemented, and the operating space is reasonably laid out. Then, for the M cell preparation processes, key biological parameter marking is performed according to N uniformity indicators, such as the uniformity of cell morphology, size, surface marker expression, etc., and key biological parameters are determined and evaluated in each process. At the same time, a monitoring system is established, and key biological parameters are regularly monitored and recorded using appropriate detection methods and instruments to ensure the quality and stability of the mesenchymal stem cell preparation process, and provide a basis for subsequent quality control.

[0021] In a possible implementation, according to the preparation operation flow, under a standard operating environment, the M cell preparation processes are labeled with key biological parameters, and the key biological parameter labels include N different uniformity indicators. Step S300 further includes step S310, establishing a cross-donor cell characterization database. Specifically, a cross-donor cell characterization database is established, and the database will collect various characteristic information of mesenchymal stem cells from different donors. By integrating data from multiple donors, a more comprehensive range of cell characteristics can be obtained, providing a rich reference basis for subsequent analysis and quality control.

[0022] Step S320, obtain the basic material information of each donor associated with the cell characterization database, and identify the quality fluctuation information of mesenchymal stem cells. Specifically, the basic material information associated with each donor is obtained from the established cell characterization database, including pathogen screening information, cell activity information, donor health status, etc., which is similar to the basic material information obtained from the target donor in the quality control plan. By analyzing the basic material information of different donors, the quality fluctuation information of mesenchymal stem cells is identified, for example, by comparing the differences in cell activity levels and pathogen screening results of different donors, determining which factors may lead to unstable cell quality, which helps to discover potential sources of quality problems and provide key focus for subsequent quality control.

[0023] Step S330 , determining the key biological parameter markers according to the preparation operation process and in a standard operating environment in comparison with the quality fluctuation information of the mesenchymal stem cells. Specifically, according to the generated preparation operation process, the various links and requirements of mesenchymal stem cell preparation are understood, and an overall framework and guidance are provided for determining key biological parameter markers. The quality fluctuation information of mesenchymal stem cells is compared with the preparation operation process, and it is analyzed in which preparation processes the quality fluctuation may occur, and which biological parameters may be affected by the quality fluctuation. For example, if it is found that the cell activity of some donors is low, it may be necessary to pay more attention to the biological parameters related to cell activity in the cell culture process. Under the standard operating environment, the preparation operation process and quality fluctuation information are comprehensively considered to determine the key biological parameter markers. It is necessary to combine professional knowledge and experience to select those biological parameters that have a greater impact on cell quality and can reflect quality fluctuations for marking. For example, uniformity indicators such as cell morphology, size, and surface marker expression are selected as key biological parameter markers so that they can be monitored and controlled in the subsequent preparation process. A cross-donor cell characterization database is established to obtain basic material information and identify quality fluctuation information. Finally, the key biological parameter markers are determined under the standard operating environment by comparing the quality fluctuation information, which provides an important basis and means for quality control of mesenchymal stem cell preparation.

[0024] In one possible implementation, according to the preparation operation process, the key biological parameter marker is determined under a standard operating environment by comparing the quality fluctuation information of the mesenchymal stem cells. Step S330 further includes step S331, according to the preparation operation process, the differentiation potential of the mesenchymal stem cells is evaluated by comparing the quality fluctuation information of the mesenchymal stem cells. Specifically, referring to the established preparation operation process, the project covers all aspects of mesenchymal stem cell preparation, including cell collection, culture, purification and other steps. The preparation operation process provides an overall framework and background knowledge for evaluating the differentiation potential of mesenchymal stem cells, and analyzes the quality fluctuation information of mesenchymal stem cells. The information is obtained by analyzing the cell characteristics of different donors, including differences in cell activity, pathogen screening results, etc. The control quality fluctuation information can help us understand which factors may affect the differentiation potential of mesenchymal stem cells. Based on the reference preparation operation process and the control quality fluctuation information, the differentiation potential of mesenchymal stem cells is evaluated. Differentiation potential refers to the ability of cells to differentiate into different types of cells under specific conditions. The differentiation potential is evaluated by various methods, such as observing the morphological changes of cells in a specific culture medium, detecting the expression level of specific genes, etc. The evaluation of differentiation potential helps to determine the application potential and direction of mesenchymal stem cells in subsequent preparation processes.

[0025] Step S332, according to the expected tissue type and differentiation potential of mesenchymal stem cells, the multiple cell growth characteristic tracking chains are configured in a directional manner. Specifically, the expected tissue type for the final application of the cells to be prepared is clarified. Different tissue types have different differentiation requirements for mesenchymal stem cells. Therefore, it is necessary to adjust the configuration of the cell growth characteristic tracking chain according to the expected tissue type. Combined with the differentiation potential of mesenchymal stem cells obtained by the previous evaluation, if the cells have a higher differentiation potential, the cell growth characteristic tracking chain can be configured more specifically to promote its differentiation into a specific tissue type. According to the expected tissue type and differentiation potential, multiple cell growth characteristic tracking chains are configured in a directional manner. The cell growth characteristic tracking chain is set during the cell preparation process to record information such as the cell's growth state, proliferation rate, and differentiation tendency. By directional configuration of the tracking chain, the differentiation process of the cell can be better monitored and guided to ensure that the cell develops towards the expected tissue type.

[0026] Step S333, introducing the requirement of preparing cells, and after the plurality of cell growth characteristic tracking chains are directed configured, simulating the differentiation process in the cell characterization simulation model. Specifically, considering the actual cell preparation requirements, including the number of required cells, quality requirements, application time and other factors, the requirements will affect the strategies and methods of cell preparation. After multiple cell growth characteristic tracking chains are configured in a targeted manner, the tracking chains can provide more accurate data and information for simulating the differentiation process. The cell growth characteristics recorded by the tracking chains can be used as input parameters in the cell characterization simulation model. In the cell characterization simulation model, the differentiation process of mesenchymal stem cells is simulated using the information provided by the tracking chains and the introduced cell preparation requirements. The cell characterization simulation model is obtained by modeling the biological characteristics and preparation process of cells, which can predict the behavior and changes of cells under different conditions. By simulating the differentiation process, the effects of different preparation strategies can be evaluated, and the parameters and conditions of cell preparation can be optimized to meet the needs of cell preparation. The differentiation potential of mesenchymal stem cells is evaluated according to the preparation operation process and quality fluctuation information. The cell growth characteristic tracking chain is configured in a targeted manner according to the expected tissue type and differentiation potential. Finally, the preparation cell requirements are introduced and the differentiation process is simulated in the cell characterization simulation model, which provides important methods and means for the quality control and optimization of mesenchymal stem cell preparation.

[0027] In a possible implementation, the demand for preparing cells is introduced, and after the multiple cell growth characteristic tracking chains are directed and configured, the differentiation process is simulated in the cell characterization simulation model, and step S333 further includes step S3331, setting a pathogen screening project according to the pathogen screening information in the material basic information. Specifically, the pathogen screening information is extracted from the acquired material basic information, and the material basic information includes pathogen screening information, cell activity information, and donor health status, etc., wherein the pathogen screening information is the test result of whether the target donor carries a specific pathogen. According to the extracted pathogen screening information, a specific pathogen screening project is set, and the project may include detection of common pathogens, such as viruses (such as hepatitis B virus, hepatitis C virus, HIV, etc.), bacteria (such as Staphylococcus aureus, Escherichia coli, etc.) and fungi, etc. The purpose of setting the screening project is to ensure that potential pathogens are not introduced during the cell preparation process, thereby ensuring the safety of cell products.

[0028] Step S3332, through the pathogen screening project, a potential pathogen set is obtained. Specifically, according to the set pathogen screening project, the target donor or cell sample is tested, and various detection methods, such as serological detection, nucleic acid detection, culture method, etc., are used to accurately identify potential pathogens. By executing the pathogen screening project, the test results are collected, and the potential pathogen set is determined. The set includes the types of pathogens found in the target donor or cell sample during the screening process. Understanding the potential pathogen set is helpful for taking targeted measures to control and eliminate the impact of pathogens.

[0029] Step S3333, through the potential pathogen set, add the cell function index associated with the disease treatment, and determine the preparation cell requirements. Specifically, for the pathogens in the potential pathogen set, analyze their possible effects on cell function and disease treatment. Different pathogens may interfere with the normal growth, differentiation and function of cells, thereby affecting the effect of cell therapy. According to the impact analysis of potential pathogens, add cell function indicators associated with disease treatment. The indicators may include the immunoregulatory ability, anti-inflammatory ability, tissue repair ability, etc. of the cells. The purpose of adding indicators is to ensure that the prepared cells can still play an effective therapeutic role in the face of potential pathogens. Considering the potential pathogen set and the added cell function indicators, determine the specific requirements for preparing cells. The requirements may include the number, purity, activity, specific functions, etc. of cells. Determining the preparation cell requirements helps to guide the subsequent cell preparation process and ensure the production of high-quality cell products that meet the treatment requirements. According to the pathogen screening information in the basic information of the materials, set the pathogen screening project, obtain the potential pathogen set, and then add the cell function indicators associated with disease treatment and determine the preparation cell requirements, which provides important basis and guidance for the quality control and therapeutic application of mesenchymal stem cell preparation.

[0030] Step S400, based on the M cell preparation processes, taking the donor health status in the basic material information as the starting point, set a plurality of cell growth characteristic tracking chains, and the cell growth characteristic tracking chains are obtained by cell growth and proliferation. Specifically, in the quality control plan for the preparation of mesenchymal stem cells, the M split cell preparation processes are first clarified, and at the same time, the donor health status in the basic material information is determined as the starting point for setting the cell growth characteristic tracking chain. As the cells grow and proliferate in each preparation process, multiple tracking chains are set to record the key parameters in the cell growth process, so as to fully understand the cell growth from multiple dimensions, such as morphology, physiology and molecular biology characteristics. During the cell preparation process, cell growth is continuously monitored to obtain tracking chain data, growth and proliferation data is recorded and the tracking chain is updated, and multiple tracking chain data are integrated and analyzed to obtain more comprehensive cell growth information, providing a basis and means for quality control and optimization.

[0031] Step S500, among the N different uniformity indicators corresponding to the key biological parameter markers, based on the pathogen screening information and cell activity information in the basic material information, and using the multiple cell growth characteristic tracking chains, a cell characterization simulation model is established. Specifically, in the quality control plan for the preparation of mesenchymal stem cells, the N uniformity indicators corresponding to the key biological parameter markers are first clarified, and the pathogen screening information and cell activity information in the basic material information are obtained at the same time. Then the data of multiple cell growth characteristic tracking chains are analyzed, key features are extracted and information is integrated. Then, based on these contents, a suitable modeling method is selected to establish a cell characterization simulation model, and after the model parameters are determined, an independent test data set is used for verification and optimization. This model can help to better understand cell growth characteristics and quality characteristics, and provide strong support for quality control and optimization.

[0032] Step S600, based on the cell characterization simulation model, abnormal cell groups in the cell culture process are marked, and a quality control cycle is set for the abnormal cell group, the quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, the quality control strategy of mesenchymal stem cells is determined, and it is bound to the target donor to perform cell preparation management of mesenchymal stem cells. Specifically, in the quality control of mesenchymal stem cell preparation, the cell culture process is monitored based on the cell characterization simulation model, the actual cell characteristics are compared with the model prediction, and the abnormal cell group is marked. A quality control cycle is set, and the optimization is performed with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, including establishing a circulation mechanism and continuously collecting data and feedback information for optimization. Determine the quality control strategy and bind it to the target donor, and strictly manage it in accordance with the strategy during the cell preparation process, including controlling the culture environment, training and supervising operators, testing the quality of raw materials and equipment, etc., continuously evaluate and adjust the strategy, improve the quality and safety of cell preparation, and provide reliable guarantee for clinical application.

[0033] In one possible implementation, based on the cell characterization simulation model, abnormal cell populations in the cell culture process are marked, and a quality control cycle is set for the abnormal cell populations. The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount. The quality control strategy of mesenchymal stem cells is determined, and the target donor is bound to perform cell preparation management of mesenchymal stem cells. Step S600 further includes step S610, adding optimized processing sites based on the potential pathogen set. Specifically, based on the determined potential pathogen set, the set includes various pathogens that may affect the quality and safety of mesenchymal stem cells. According to the characteristics of the potential pathogens and the requirements of cell preparation, the sites that can be optimized are determined. The sites are specific steps in the cell preparation operation process, or treatment methods for specific pathogens. For example, specific antibiotics or antiviral drugs can be added during the cell culture process, or specific filtration or centrifugation methods can be used to remove pathogens in the cell purification step.

[0034] Step S620, collect optimization treatment monitoring data through the verification information of the optimization treatment site, and the optimization treatment monitoring data includes pathogen clearance rate. Specifically, the determined optimization treatment site is verified through experiments or simulations to ensure that the optimization treatment site can effectively remove or reduce the impact of potential pathogens. The verification process may include detecting the pathogen content in cells before and after treatment, observing cell growth and functional changes, etc. In the process of verifying the optimization treatment site, the optimization treatment monitoring data is collected, and the data includes pathogen clearance rate, that is, the reduction ratio of pathogens in cells after treatment, and other relevant data are collected, such as cell activity, purity, function and other indicators to evaluate the overall impact of the optimization treatment on cell quality, and the collected optimization treatment monitoring data is analyzed, and the pathogen clearance rate and other data are analyzed to determine the effectiveness and efficiency of the optimization treatment site. If the pathogen clearance rate is low, it is necessary to adjust the parameters or methods of the optimization treatment site to improve the removal effect of the pathogen.

[0035] Step S630, through the optimization processing monitoring data, evaluate the residual amount in the preparation operation process, and configure the first improvement sub-cycle in the quality control cycle. Specifically, the optimization processing monitoring data is used to evaluate the residual amount in the preparation operation process. The residual amount may include the residue of pathogens, the residue of optimization processing reagents, etc. The purpose of evaluating the residual amount is to ensure that the cell product still meets the quality and safety standards after the optimization treatment. According to the evaluation result of the residual amount, the first improvement sub-cycle in the quality control cycle is configured. The first improvement sub-cycle is part of the quality control cycle, which aims to improve specific problems in the preparation operation process. For example, if the pathogen residue is found to be high, an additional pathogen removal step can be added to the first improvement sub-cycle or the parameters of the existing steps can be adjusted. When configuring the first improvement sub-cycle, factors such as the cost, efficiency and impact of the optimization treatment on cell quality need to be considered. Optimization treatment sites are added based on the potential pathogen set, and optimization processing monitoring data, including pathogen clearance rate, etc., are collected through verification information. Then, these data are used to evaluate the residual amount in the preparation operation process, and the first improvement sub-cycle in the quality control cycle is configured to continuously improve the quality and safety of mesenchymal stem cell preparation.

[0036] In a possible implementation, the monitoring data is processed by the optimization, the residual amount in the preparation operation process is evaluated, and the first improved sub-cycle in the quality control cycle is configured. Step S630 further includes step S631, and the simulated behavior information and simulated reaction information under the standard operating environment are determined by the cell characterization simulation model. Specifically, the established cell characterization simulation model is called, and the model is constructed based on multiple data such as key biological parameter markers, pathogen screening information, cell activity information, and cell growth characteristic tracking chain. It can simulate the behavior and reaction of cells under different conditions, and clarify various parameters of the standard operating environment, including temperature, humidity, gas concentration, culture medium components, etc. Parameters are factors that need to be strictly controlled during the cell preparation process to ensure the quality and stability of cells. Through the cell characterization simulation model, the behavior and reaction of cells are simulated under the standard operating environment, including cell growth, division, differentiation, metabolism and other processes, as well as the response of cells to external stimuli. The obtained simulated behavior information may include the position, movement trajectory, morphological changes, etc. of cells; the simulated reaction information may include the absorption and metabolism of cells to different culture medium components, the response to drugs or other treatments, etc.

[0037] Step S632, continuously monitor the simulated behavior information and simulated reaction information, and identify stability indicators, which include cell growth rate, cell morphology, and metabolic activity. Specifically, a monitoring system is set to continuously monitor the simulated behavior information and simulated reaction information. The monitoring can be carried out in real time, or data can be collected regularly for analysis. Through continuous monitoring, changes in cell behavior and reaction can be discovered in time so that corresponding measures can be taken. From the monitored simulated behavior information and simulated reaction information, stability indicators are identified. Stability indicators are key parameters reflecting the stability of cells during the preparation process, including cell growth rate, cell morphology, and metabolic activity. Cell growth rate can be determined by monitoring the rate of increase in the number of cells; cell morphology can be evaluated by microscopic observation or image analysis; metabolic activity can be measured by detecting indicators such as cell metabolites and energy consumption. The identified stability indicators are analyzed to understand the stability of the cells. If the cell growth rate is too fast or too slow, the cell morphology changes abnormally, the metabolic activity decreases, etc., it may indicate that the stability of the cells is affected, and further investigation of the cause is required and measures should be taken to adjust.

[0038] Step S633, configure the second improved sub-cycle in the quality control cycle through the cell growth rate, cell morphology, and metabolic activity in the stability indicators. Specifically, based on stability indicators such as cell growth rate, cell morphology, and metabolic activity, evaluate the stability problems in the cell preparation process, determine which indicators are abnormal, and the degree of the abnormality and the scope of influence. According to the analysis results of the stability indicators, configure the second improved sub-cycle in the quality control cycle. The second improved sub-cycle is a specific link for improving stability problems, aiming to improve the stability and quality of cells. For example, if the cell growth rate is too fast, the culture medium components or culture conditions can be adjusted in the second improved sub-cycle to control the cell growth rate; if the cell morphology is abnormal, the cell morphology monitoring and screening can be strengthened to remove cells with abnormal morphology; if the metabolic activity To reduce it, the culture environment can be optimized or specific nutrients can be added to improve the metabolic activity of the cells. By configuring the second improved sub-loop, the quality control loop can be further optimized. The quality control measures can be continuously adjusted and improved to ensure that the stability and quality of the cell preparation process are always under control. The stability indicators can be continuously monitored. The second improved sub-loop can be adjusted and improved according to actual conditions. The cell characterization simulation model can be used to determine the simulated behavior information and simulated reaction information under the standard operating environment. This information can be continuously monitored and stability indicators can be identified. Then, the second improved sub-loop in the quality control loop can be configured through the stability indicators to improve the quality and stability of mesenchymal stem cell preparation.

[0039] In a possible implementation, the second improved sub-cycle in the quality control cycle is configured by the cell growth rate, cell morphology, and metabolic activity in the stability index, and step S633 further includes step S6331, in which immune adverse reaction monitoring is performed in the quality control cycle, and associated monitoring data is collected. Specifically, it is ensured that the quality control cycle is already in operation. The cycle is established to ensure the quality and safety of mesenchymal stem cell preparation, including multiple sub-cycles and monitoring mechanisms. In the quality control cycle, immune adverse reaction monitoring is specifically performed, because mesenchymal stem cells may cause immune adverse reactions during application, such as allergies, inflammation, etc. By monitoring immune adverse reactions, potential problems can be discovered in time and corresponding measures can be taken. While monitoring immune adverse reactions, relevant monitoring data are collected. The data may include the patient's symptoms, signs, laboratory test results, etc., as well as cell characteristics related to immune adverse reactions, preparation process parameters, etc. The collected associated monitoring data will provide a basis for subsequent analysis and decision-making.

[0040] Step S6332, through the associated monitoring data, in comparison with the first improved sub-cycle, a stability determination mechanism and a first risk factor are set. Specifically, the collected associated monitoring data are analyzed in detail, focusing on data related to immune adverse reactions and factors that may affect cell stability, and the associated monitoring data are compared with the first improved sub-cycle in the quality control cycle. The first improved sub-cycle is mainly optimized for the residual amount in the preparation operation process to improve the stability of the cells. According to the comparison results of the associated monitoring data and the first improved sub-cycle, a stability determination mechanism is set to determine the stability state of the cells during the preparation and application process. For example, some indicators such as cell activity, morphology, function, etc. can be set. When the indicators exceed a certain range, it is determined that there is a problem with cell stability. By comparing the associated monitoring data and the first improved sub-cycle, the first risk factor related to cell stability is determined. The risk factors may include improper operation in the preparation process, raw material quality problems, environmental factors, etc. Determining the first risk factor helps to take targeted measures to reduce risks and improve cell stability.

[0041] Step S6333, through the associated monitoring data, in comparison with the second improved sub-cycle, a residual amount determination mechanism and a second risk factor are set. Specifically, the associated monitoring data are further analyzed, and this time the focus is on the data related to the residual amount. The residual amount refers to the harmful substances that may remain in the cell preparation process, such as pathogens, impurities, etc. The associated monitoring data are compared with the second improved sub-cycle in the quality control cycle. The second improved sub-cycle is mainly optimized for stability indicators such as cell growth rate, cell morphology, and metabolic activity. According to the comparison results of the associated monitoring data and the second improved sub-cycle, a residual amount determination mechanism is set. The mechanism is used to determine whether the level of residual amount in the cell meets the safety standard. For example, some detection methods and indicators can be set, such as pathogen detection, impurity content determination, etc. When the residual amount exceeds a certain limit, it is determined that there is a safety risk. By comparing the associated monitoring data with the second improved sub-cycle, the second risk factor related to the residual amount is determined. The risk factor may include contamination in the preparation process, equipment failure, operational errors, etc. Determining the second risk factor helps to take corresponding measures to reduce the residual amount and improve the safety of the cells.

[0042] Step S6334, updating the quality control cycle through the first improved sub-cycle, the stability determination mechanism and the first risk factor, and the second improved sub-cycle, the residue determination mechanism and the second risk factor. Specifically, the first improved sub-cycle, the stability determination mechanism and the first risk factor, as well as the second improved sub-cycle, the residual determination mechanism and the second risk factor are comprehensively considered. The factors jointly affect the quality and safety of mesenchymal stem cell preparation. According to the results of the comprehensive consideration, the quality control cycle is updated, including adjusting the parameters of the improved sub-cycle, optimizing the determination mechanism, strengthening the control of risk factors, etc. By continuously updating the quality control cycle, its effectiveness and adaptability can be improved to ensure that the cell preparation process is always in a good control state. After updating the quality control cycle, immune adverse reaction monitoring and related monitoring data collection continue. According to new data and situations, the quality control cycle is continuously adjusted and improved to achieve continuous quality improvement and risk control. Immune adverse reaction monitoring is carried out in the quality control cycle, and related monitoring data is collected. The stability determination mechanism and the first risk factor, the residual determination mechanism and the second risk factor are set respectively in comparison with the first and second improved sub-cycles. Finally, the quality control cycle is updated through these factors, thereby continuously improving the quality and safety of mesenchymal stem cell preparation.

[0043] The embodiment of the present application adopts the method of obtaining basic material information including pathogen screening information, cell activity information and donor health status based on the target donor. According to the confirmation information of the cell preparation device, the preparation operation process is generated and divided into M cell preparation processes, and key biological parameter marking (including N uniformity indicators) is performed on these processes under the standard operating environment. Taking the donor health status as the starting point, a cell growth characteristic tracking chain is set based on M processes, and a cell characterization simulation model is established in the uniformity indicators marked with key biological parameters using the tracking chain and pathogen screening information and cell activity information. Based on the model, abnormal cell populations are marked and a quality control cycle is set to optimize the stability of mesenchymal stem cells and reduce the residual amount, and the quality control strategy is determined to be bound to the target donor for cell preparation management. By comprehensively evaluating the donor materials, finely managing the preparation process, tracking cell growth in real time and effectively handling abnormal cells, the technical effect of improving the safety and quality stability of mesenchymal stem cell preparation is achieved.

[0044] In the above, refer to Figure 1 The quality control method for preparing mesenchymal stem cells according to an embodiment of the present invention is described in detail. Figure 2 A quality control platform for mesenchymal stem cell preparation according to an embodiment of the present invention is described.

[0045] The quality control platform for mesenchymal stem cell preparation according to the embodiment of the present invention is used to solve the technical problems in the prior art that the mesenchymal stem cell preparation process lacks comprehensive donor evaluation and cannot effectively handle abnormal cells. By comprehensively evaluating donor materials, carefully managing the preparation process, tracking cell growth in real time and effectively handling abnormal cells, the technical effect of improving the safety and quality stability of mesenchymal stem cell preparation is achieved. The quality control platform for mesenchymal stem cell preparation includes: a material basic information acquisition module 10, a preparation operation process generation module 20, a biological parameter labeling module 30, a growth characteristic tracking chain setting module 40, a cell characterization simulation model establishment module 50, and a quality control strategy determination module 60.

[0046] The basic material information acquisition module 10 is used to acquire basic material information based on the target donor, and the basic material information includes pathogen screening information, cell activity information, and donor health status.

[0047] The preparation operation flow generation module 20 is used to synchronize the operation confirmation information and the performance confirmation information according to the cell preparation device, and generate the preparation operation flow, and split and obtain M cell preparation processes.

[0048] The biological parameter labeling module 30 is used to label the M cell preparation processes with key biological parameters according to the preparation operation flow under a standard operating environment. The key biological parameter labels include N different uniformity indicators.

[0049] The growth characteristic tracking chain setting module 40 is used to set multiple cell growth characteristic tracking chains based on the M cell preparation processes and taking the donor health status in the material basic information as the starting point. The cell growth characteristic tracking chains are obtained by cell growth and proliferation.

[0050] The cell characterization simulation model establishment module 50 is used to establish a cell characterization simulation model among the N different uniformity indicators corresponding to the key biological parameter markers, based on the pathogen screening information and cell activity information in the basic material information, and using the multiple cell growth characteristic tracking chains.

[0051] The quality control strategy determination module 60 is used to mark abnormal cell populations in the cell culture process based on the cell characterization simulation model, and set a quality control cycle for the abnormal cell population. The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, determines the quality control strategy of mesenchymal stem cells, and binds to the target donor to perform cell preparation management of mesenchymal stem cells.

[0052] The specific configuration of the biological parameter labeling module 30 will be described in detail below. As described above, according to the preparation operation flow, under the standard operating environment, the M cell preparation processes are labeled with key biological parameters, and the key biological parameter labels include N different uniformity indicators. The biological parameter labeling module 30 further includes: a cell characterization database establishment unit, which is used to establish a cell characterization database across donors; a quality fluctuation information identification unit, which is used to obtain the basic material information of each donor associated with the cell characterization database and identify the quality fluctuation information of mesenchymal stem cells; a key biological parameter labeling determination unit, which is used to determine the key biological parameter labels under the standard operating environment according to the preparation operation flow and the quality fluctuation information of the mesenchymal stem cells.

[0053] Among them, according to the preparation operation process, in comparison with the quality fluctuation information of the mesenchymal stem cells, the key biological parameter markers are determined under a standard operating environment, and the key biological parameter marker determination unit further includes: a differentiation potential evaluation subunit, the differentiation potential evaluation subunit is used to evaluate the differentiation potential of mesenchymal stem cells according to the preparation operation process and in comparison with the quality fluctuation information of the mesenchymal stem cells; a directional configuration subunit, the directional configuration subunit is used to directionally configure the multiple cell growth characteristic tracking chains according to the expected tissue type and the differentiation potential of the mesenchymal stem cells; a simulated differentiation subunit, the simulated differentiation subunit is used to introduce preparation cell requirements, and after the multiple cell growth characteristic tracking chains are directionally configured, simulate the differentiation process in the cell characterization simulation model.

[0054] Among them, the demand for preparing cells is introduced, and after the multiple cell growth characteristic tracking chains are directed configured, the differentiation process is simulated in the cell characterization simulation model, and the simulated differentiation subunit further includes: a pathogen screening project setting microunit, the pathogen screening project setting microunit is used to set the pathogen screening project according to the pathogen screening information in the material basic information; a pathogen set acquisition microunit, the pathogen set acquisition microunit is used to obtain a potential pathogen set through the pathogen screening project; a cell demand determination microunit, the cell demand determination microunit is used to add cell function indicators associated with disease treatment through the potential pathogen set, and determine the cell preparation demand.

[0055] Below, the specific configuration of the quality control strategy determination module 60 will be described in detail. As described above, based on the cell characterization simulation model, the abnormal cell population in the cell culture process is marked, and a quality control cycle is set for the abnormal cell population. The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, and the quality control strategy of mesenchymal stem cells is determined, and bound to the target donor to perform cell preparation management of mesenchymal stem cells. The quality control strategy determination module 60 further includes: an optimized treatment site addition unit, the optimized treatment site addition unit is used to add optimized treatment sites based on the potential pathogen set; a processing monitoring data optimization unit, the processing monitoring data optimization unit is used to collect optimized treatment monitoring data through the verification information of the optimized treatment site, and the optimized treatment monitoring data includes pathogen clearance; a first improved sub-cycle configuration unit, the first improved sub-cycle configuration unit is used to evaluate the residual amount in the preparation operation process through the optimized treatment monitoring data, and configure the first improved sub-cycle in the quality control cycle.

[0056] Among them, the monitoring data is monitored through the optimization processing, the residual amount in the preparation operation process is evaluated, and the first improved sub-cycle in the quality control cycle is configured, and the first improved sub-cycle configuration unit further includes: a simulation information determination sub-unit, the simulation information determination sub-unit is used to determine the simulated behavior information and simulated reaction information under the standard operating environment through the cell characterization simulation model; a stability index identification sub-unit, the stability index identification sub-unit is used to continuously monitor the simulated behavior information and simulated reaction information, and identify stability indicators, and the stability indicators include cell growth rate, cell morphology, and metabolic activity; a second improved sub-cycle configuration sub-unit, the second improved sub-cycle configuration sub-unit is used to configure the second improved sub-cycle in the quality control cycle through the cell growth rate, cell morphology, and metabolic activity in the stability indicators.

[0057] Among them, the second improved sub-cycle in the quality control cycle is configured by the cell growth rate, cell morphology and metabolic activity in the stability indicators, and the second improved sub-cycle configuration subunit further includes: an associated monitoring data collection microunit, the associated monitoring data collection microunit is used to perform immune adverse reaction monitoring and collect associated monitoring data in the quality control cycle; a stability judgment mechanism setting microunit, the stability judgment mechanism setting microunit is used to set the stability judgment mechanism and the first risk factor by comparing the associated monitoring data with the first improved sub-cycle; a residual amount judgment mechanism setting microunit, the residual amount judgment mechanism setting microunit is used to set the residual amount judgment mechanism and the second risk factor by comparing the associated monitoring data with the second improved sub-cycle; a quality control cycle update microunit, the quality control cycle update microunit is used to update the quality control cycle through the first improved sub-cycle, the stability judgment mechanism and the first risk factor, and the second improved sub-cycle, the residual amount judgment mechanism and the second risk factor.

[0058] The quality control platform for mesenchymal stem cell preparation provided by the embodiment of the present invention can execute the quality control method for mesenchymal stem cell preparation provided by any embodiment of the present invention, and has the corresponding functional modules and beneficial effects of the execution method.

[0059] Although the present application makes various references to certain modules in the platform according to the embodiments of the present application, any number of different modules may be used and run on the user terminal and / or server, and the various units and modules included are only divided according to functional logic, but are not limited to the above division, as long as the corresponding functions can be implemented; in addition, the specific names of the functional units are only for the convenience of distinguishing each other, and are not used to limit the scope of protection of the present invention.

[0060] The above specific implementation manner does not constitute a limitation to the protection scope of the present application. It should be understood by those skilled in the art that various modifications, combinations and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application. In some cases, the actions or steps recorded in the present application can be performed in an order different from that in the embodiment and can still achieve the desired results. In addition, the process depicted in the accompanying drawings does not necessarily require the specific order or continuous order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

Claims

1. A quality control method for preparing mesenchymal stem cells, characterized in that: The method comprises: Based on the target donor, basic material information is obtained, wherein the basic material information includes pathogen screening information, cell activity information, and donor health status; According to the cell preparation device, synchronous operation confirmation information and performance confirmation information are obtained, and a preparation operation flow is generated, and M cell preparation processes are obtained by splitting; According to the preparation operation flow, under a standard operating environment, key biological parameter labeling is performed on the M cell preparation processes, wherein the key biological parameter labeling includes N different uniformity indicators; Based on the M cell preparation processes, and taking the donor health status in the basic material information as a starting point, a plurality of cell growth characteristic tracking chains are set, wherein the cell growth characteristic tracking chains are obtained by cell growth and proliferation; Among the N different uniformity indicators corresponding to the key biological parameter markers, based on the pathogen screening information and cell activity information in the basic material information, and using the multiple cell growth characteristic tracking chains, a cell characterization simulation model is established; Based on the cell characterization simulation model, abnormal cell populations in the cell culture process are marked, and a quality control cycle is set for the abnormal cell populations. The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount. The quality control strategy of mesenchymal stem cells is determined, and the target donor is bound to perform cell preparation management of mesenchymal stem cells.

2. The quality control method for preparing mesenchymal stem cells according to claim 1, characterized in that: According to the preparation operation flow, under a standard operating environment, key biological parameter marking is performed on the M cell preparation processes, wherein the key biological parameter marking includes N different uniformity indicators, and the method includes: Establish a cell characterization database across donors; Obtaining basic material information of each donor associated with the cell characterization database, and identifying quality fluctuation information of mesenchymal stem cells; According to the preparation operation process, the key biological parameter markers are determined under a standard operating environment by comparing the quality fluctuation information of the mesenchymal stem cells.

3. The quality control method for preparing mesenchymal stem cells according to claim 2, characterized in that: According to the preparation operation process, and in comparison with the quality fluctuation information of the mesenchymal stem cells, under a standard operating environment, the key biological parameter marker is determined, and the method comprises: According to the preparation operation process, and in comparison with the quality fluctuation information of the mesenchymal stem cells, the differentiation potential of the mesenchymal stem cells is evaluated; Directively configuring the multiple cell growth characteristic tracking chains according to the expected tissue type and differentiation potential of the mesenchymal stem cells; The requirement for preparing cells is introduced, and after the plurality of cell growth characteristic tracking chains are directed configured, the differentiation process is simulated in the cell characterization simulation model.

4. The quality control method for preparing mesenchymal stem cells according to claim 3, characterized in that: Introducing the need for preparing cells, after the plurality of cell growth characteristic tracking chains are directed configured, simulating the differentiation process in the cell characterization simulation model, the method comprising: According to the pathogen screening information in the basic information of the material, set up pathogen screening items; Obtaining a collection of potential pathogens through the pathogen screening project; Through the potential pathogen collection, cell function indicators associated with disease treatment are added, and the cell preparation requirements are determined.

5. The quality control method for preparing mesenchymal stem cells according to claim 4, characterized in that: The quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, and a quality control strategy for mesenchymal stem cells is determined. The method includes: adding optimized treatment sites based on the potential pathogen set; Collecting optimized treatment monitoring data through verification information of the optimized treatment site, wherein the optimized treatment monitoring data includes pathogen clearance rate; The monitoring data is processed through the optimization, the residual amount in the preparation operation process is evaluated, and the first improvement sub-cycle in the quality control cycle is configured.

6. The quality control method for preparing mesenchymal stem cells according to claim 5, characterized in that: By optimizing the monitoring data, evaluating the residual amount in the preparation operation process, and configuring the first improvement sub-cycle in the quality control cycle, the method further includes: Determining simulated behavior information and simulated response information under a standard operating environment through the cell characterization simulation model; Continuously monitoring the simulated behavior information and simulated reaction information, and identifying stability indicators, wherein the stability indicators include cell growth rate, cell morphology, and metabolic activity; The second improvement sub-cycle in the quality control cycle is configured according to the cell growth rate, cell morphology and metabolic activity among the stability indicators.

7. The quality control method for preparing mesenchymal stem cells according to claim 6, characterized in that: The method comprises: During the quality control cycle, immune adverse reaction monitoring is performed and related monitoring data is collected; By comparing the associated monitoring data with the first improvement sub-cycle, setting a stability determination mechanism and a first risk factor; By using the associated monitoring data and comparing the second improved sub-cycle, a residual amount determination mechanism and a second risk factor are set; The quality control cycle is updated through the first improvement sub-cycle, the stability determination mechanism and the first risk factor, and the second improvement sub-cycle, the residue determination mechanism and the second risk factor.

8. A quality control platform for mesenchymal stem cell preparation, characterized in that: The platform is used to implement the quality control method for preparing mesenchymal stem cells according to any one of claims 1 to 7, and the platform comprises: A material basic information acquisition module, which is used to acquire material basic information based on the target donor, wherein the material basic information includes pathogen screening information, cell activity information, and donor health status; A preparation operation flow generation module, wherein the preparation operation flow generation module is used to synchronize the operation confirmation information and the performance confirmation information according to the cell preparation device, and generate a preparation operation flow, and split and obtain M cell preparation processes; A biological parameter labeling module, the biological parameter labeling module is used to label the M cell preparation processes with key biological parameters according to the preparation operation process under a standard operating environment, wherein the key biological parameter labels include N different uniformity indicators; A growth characteristic tracking chain setting module, wherein the growth characteristic tracking chain setting module is used to set a plurality of cell growth characteristic tracking chains based on the M cell preparation processes and taking the donor health status in the material basic information as a starting point, wherein the cell growth characteristic tracking chains are obtained by cell growth and proliferation; A cell characterization simulation model establishment module, wherein the cell characterization simulation model establishment module is used to establish a cell characterization simulation model based on the pathogen screening information and cell activity information in the material basic information and by using the multiple cell growth characteristic tracking chains among the N different homogeneity indicators corresponding to the key biological parameter markers; A quality control strategy determination module, the quality control strategy determination module is used to mark abnormal cell populations in the cell culture process based on the cell characterization simulation model, and set a quality control cycle for the abnormal cell population, the quality control cycle is optimized with the goal of maximizing the stability of mesenchymal stem cells and minimizing the residual amount, determine the quality control strategy of mesenchymal stem cells, and bind with the target donor to perform cell preparation management of mesenchymal stem cells.

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