CN107590632A - A kind of management system and method, server for the transport of cell production inventory - Google Patents
A kind of management system and method, server for the transport of cell production inventory Download PDFInfo
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Abstract
The invention discloses a kind of management system for the transport of cell production inventory and method, server, system to include：Produce module, storage module and transportation module, the production module, to collect cell production sample, and identity is increased by an internet-of-things terminal, cell is correspondingly produced according to the identity, the storage module, to provide the api interface for receiving the storage condition for the cell produced and providing customer account management end access after storage in management server, the transportation module, to ship the cell in the storage module, and the nodal information in transportation is obtained by a visualization terminal in real time.Efficient, system of the invention, and can ensure that cell production inventory transports the effective management and control during whole product link.The present invention can provide detailed information support for production line operation, whole-process management, control of product quality and Treatment decsion, while can improve cell therapy industry operating efficiency.
Description
Technical field
The present invention relates to biological field technology, more particularly to a kind of management system transported for cell production inventory, side
Method.
Background technology
At present, most cells production laboratory in China's still uses traditional paper and by hand preservation side to quality information management
Method, this method data-handling efficiency is relatively low, human error easily occurs, does not accomplish the real-time tracking of data and the statistical of science
Analysis, the feedback for the effect that can not be obtained medical treatment in time from clinical endpoint, it is difficult to instruct whole production link.And pass through and be
The generation of system and the data message being collected into stored, updated and safeguarded, can be production line operation, whole-process management,
Control of product quality and Treatment decsion provide detailed information support, while can improve cell therapy industry operating efficiency,
Lifting simultaneously to cell therapy clinical efficacy is also helpful.
Nowadays, with the rapid development of Internet of Things and computer intelligence hardware, how computer software, hardware, net to be utilized
Network communication apparatus and other cooperative devices, the product complete " life cycle " of the production of cell, transport, storage is carried out effectively
Management and control, are that those skilled in the art have technical problem to be solved.
For example by taking immunocyte as an example, immunocyte not only has a preferable prospect in terms for the treatment of cancer, and from health
From the perspective of health, it can also be extracted in sufferers themselves' health and immunocyte is extracted from its peripheral blood, and suffered from afterwards
When immunocompromised or other symptoms occurs in person, the immunocyte of storage can be fed back to sufferers themselves, improve patient's
Immunity.However, the studies and clinical application of immunocyte is a multidisciplinary, more units, multidisciplinary common coordination completion
One great complex work provides cell, it is necessary to there is independent cell to prepare unit, and independent cell transplantation unit carries out cell
Transplanting, and cell is prepared between unit and cell transplantation unit certain space length, cell is set to prepare unit and thin
Born of the same parents transplant unit and are fully connected at work, cell transplantation is reached optimal efficiency it is necessary to there is the specification that can reach standard
Cell storage transport courses, it is necessary to store the preexisting immunity cell of transport suffered from storage, transhipment, cell etc. it is very tight
The requirement of lattice, unified specification flow is not formed also in terms of the storage transport of immunocyte at present.In the prior art
Major defect is：
1) during how ensureing cell production inventory, immunocyte is separating, freeze, recover, in transportation, will not
Damage is produced to individual cells, reduces the danger of biological injury；
2) how to ensure during how ensureing cell production inventory, point cellifugal separation rate, purity etc. are to immune thin
The application of born of the same parents also has significant effect.
3) how to ensure how to ensure in cellular transport processes, solve to have between cell preparation unit and cell transplantation unit
Certain space length, cell preparation unit and cell transplantation unit is set fully to be connected at work, it is ensured that cell transplantation reaches
To optimal efficiency.
The content of the invention
The technical problem to be solved in the present invention is, it is a kind of efficiently, system can ensure that the transport of cell production inventory is whole
The management system for being used for the transport of cell production inventory of effective management and control during product link.
Solve above-mentioned technical problem, the invention provides a kind of management system for the transport of cell production inventory, including：
Module, storage module and transportation module are produced,
The production module, to collect cell production sample, and identity is increased by an internet-of-things terminal,
Cell is correspondingly produced according to the identity,
The storage module, the storage condition for the cell produced is received and in management server after storage to provide
The api interface of one customer account management end access is provided,
The transportation module, to ship the cell in the storage module, and obtained in real time by a visualization terminal
Nodal information in transportation.
Further, the production module includes：Collecting unit, identity recognizing unit, identity authentication unit, production equipment
Administrative unit,
The collecting unit, to collect cell sample from cell derived place,
The identity recognizing unit, to identify the identity information of the cell sample,
The identity authentication unit, to check the identity information be to matching,
The production equipment administrative unit, to call different production equipments to carry out cell production.
Further, the storage module includes：Environment unit, flow management and control unit, quality management unit,
The environment unit, to provide storage condition and relevant device,
The flow management and control unit, to establish the control of the flow nodes of standardized management,
The quality management unit, to carry out quality assurance, quality monitoring and save file management.
Further, the transportation module includes：Delivery unit, transportation environment unit, transport dispensing unit are classified,
The classification delivery unit is to be transported thin to provide the cell after cell production sample, production and production
The classification of born of the same parents does not transport interface,
The transportation environment unit, to provide the transport option interface of different cell transportation environments,
The transport dispensing unit, interface is configured to provide the transport of different stage transport.
Further, the management system also includes：Labor management module, the labor management module include：Produce people
Work management port, transport labor management port, collection source labor management port, equipment labor management port, environment labor management
Port,
The productive manpower management port, to provide production process labor management service interface,
The transport labor management port, to provide transportation labor management service interface,
The collection source labor management port, to provide collection source labor management service interface,
The equipment labor management port, to provide the labor management service interface of production, storage and transporting equipment,
The environment labor management port, to provide the labor management service interface of production, storage and transportation environment.
Further, the management system also includes：Clinography unit is thin to assess cell therapy effect and feedback
Born of the same parents' service condition, the clinography unit and the data syn-chronization in management server.
Further, the internet-of-things terminal includes：Based on NFC, bluetooth, RF radio frequencies, Zigbee wireless communication protocols
Terminal.
Further, the visualization terminal includes：Visualization window based on HTML5/touch window.
Based on above-mentioned, a kind of management method for the transport of cell production inventory is additionally provided in the present invention, including it is as follows
Step：
Cell production sample is collected, and identity is increased by an internet-of-things terminal, according to the identity
Corresponding production cell,
The storage condition for receiving the cell produced is provided and provides a customer account management end after being stored in management server
The api interface of access,
The cell in the storage module is shipped, and the node in transportation is obtained by a visualization terminal in real time and believed
Breath.
Present invention also offers a kind of management server, including：
The management request of Web server is received, the management request comprises at least：Cell production sample is collected, and
Identity is increased by an internet-of-things terminal, cell is correspondingly produced according to the identity,
The storage condition for receiving the cell produced is provided and provides a customer account management end after being stored in management server
The api interface of access,
The cell in the storage module is shipped, and the node in transportation is obtained by a visualization terminal in real time and believed
Breath,
Above-mentioned request provides the approach for accessing cell production inventory and transporting to browser by apps server, for
Subscription client application program uses.
Beneficial effects of the present invention：
1) management system for being used for the transport of cell production inventory in the present invention, due to including production module, storage module
And transportation module, the production module increase identity to collect cell production sample by an internet-of-things terminal
Mark, cell is correspondingly produced according to the identity.The cell to be produced collected can be sampled and record, due to increasing
Identity has been added to find corresponding production cell.Because the storage module to provide receives the storage of cell produced
Dis environment and the api interface for providing customer account management end access after storage in management server, can be provided by api interface
The interface of data access/calling, and special storage condition is provided in the storage module.Because the transportation module is used
To ship the cell in the storage module, and the nodal information in transportation is obtained by a visualization terminal in real time, can
With the just-in-time of implementation process management and intellectuality.
2) further, increased identity can be used for carrying out the operating personnel of device end on internet-of-things terminal
Identification, pass through the qualification for the verification operation personnel such as start that swipe the card, it is ensured that the safe handling to device end.And identity mark
Knowing can be used by the form of internet label in whole complete flow, be realized to the cytoplasm since sampling
Measure information system management.
3) further, supporting transport courses can by way of visualizing terminal real-time display in transportation
All node procedure informations, it is ensured that the shipment of cell is transparence.
Brief description of the drawings
Fig. 1 is the structural representation of the management system for being used for the transport of cell production inventory in one embodiment of the invention；
Fig. 2 is the preferred structure schematic diagram in Fig. 1；
Fig. 3 is the production modular structure schematic diagram in Fig. 1；
Fig. 4 is the storage module structural representation in Fig. 1；
Fig. 5 is the transportation module structural representation in Fig. 1；
Fig. 6 is the system structure diagram in one embodiment of the invention；
Fig. 7 is the labor management modular structure schematic diagram in Fig. 6；
Fig. 8 is the system structure diagram in another embodiment of the present invention；
Fig. 9 is the management method schematic flow sheet for being used for the transport of cell production inventory in one embodiment of the invention；
Figure 10 is the management server structural representation in the present invention.
Embodiment
The principle of the disclosure is described referring now to some example embodiments.It is appreciated that these embodiments are merely for saying
It is bright and help it will be understood by those skilled in the art that with the purpose of the embodiment disclosure and describe, rather than suggest the model to the disclosure
Any restrictions enclosed.Content of this disclosure described here can in a manner of described below outside various modes implement.
As described herein, term " comprising " and its various variants are construed as open-ended term, it means that " bag
Include but be not limited to ".Term "based" is construed as " being based at least partially on ".Term " one embodiment " it is understood that
For " at least one embodiment ".Term " another embodiment " is construed as " at least one other embodiment ".
Cell in the application includes but is not limited to, immunocyte, and immunocyte refers to participate in immune response or with being immunized
The related cell of response, including lymphocyte, BMDC, Monocytes/Macrophages, granulocyte, mast cell etc..In recent years
The immunotherapy techniques of tumour and virus are applied to clinic, can be right through stimulated in vitro, culture, amplification by autologous immunocyte
Feed back afterwards to improve the immunity of patient.Immune cell therapy is essentially from patient itself peripheral blood, by separating and collecting
To PMNC.But it is, in general, that the colony for receiving immune cell therapy is mainly tumour or viral infection population,
Such crowd immunocyte function of itself is very low, and it is relatively low to isolate immunologic cellular activity.Therefore people can be certainly
When body immunologic cellular activity is strong, healthy cell is stored in advance, in case the need cured the disease in the future.
System architecture in the application is based on browser/server (browser/server, B/S) pattern, can pass through
LAN or internet carry out business processing whenever and wherever possible.Database in back-stage management server has using Microsoft
SQL Server 2008.Back-stage management server uses Windows server2012, supports single-point or concentrating type deployment, branch
Hold millions business datum stable operation.
The internet-of-things terminal in this application includes：Based on NFC, bluetooth, RF radio frequencies, Zigbee wireless communication protocols
Terminal.NFC identifies that (RFID) is developed by non-contact radio-frequency, and by Philips Semiconductors, (existing grace intelligence Pu semiconductor is public
Department), Nokia and Sony develop jointly, its basis is RFID and interconnection technique.Near-field communication (Near Field
Communication, NFC) it is a kind of radiotechnics of short distance high frequency, run on 10 cm distances in 13.56MHz frequencies
It is interior.The preferred agreement of bluetooth 4.0 of bluetooth, bluetooth 4.0 is integrated by three kinds of specifications, including traditional bluetooth technology, high speed technology and low
Power consumption technology, maximum difference is exactly low-power consumption compared with 3.0 versions.The power consumption older version of 4.0 versions reduces 90%, more
Power saving, 4.0 versions enhance low power capabilities of the bluetooth in data transfer.Radio frequency (RF) is Radio Frequency contracting
Write, represent that the electromagnetic frequency in space can be radiated, frequency range is between 300KHz~300GHz.ZigBee is to be based on
The low-power consumption LAN protocol of IEEE802.15.4 standards.Provided according to international standard, ZigBee technology is a kind of short distance, low
The wireless communication technology of power consumption.
The visualization terminal in this application includes：Visualization window based on HTML5/touch window, HTML5 are
5th generation HTML (Hyper Text Markup Language), HTML describe webpage using mark label.
GMP standards in the application, (GMP) are to ensure that medicine is held under defined quality
The system of continuous production.It is for the underproof danger in drug production process is reduced to minimum conclude.
Below in an example, with immunocyte as the presently preferred embodiments, the technical scheme of the application is carried out in detail
Explanation.
It refer to the structural representation that Fig. 1 is the management system for being used for the transport of cell production inventory in one embodiment of the invention
Figure, system in the present embodiment include：Module 1, storage module 2 and transportation module 3 are produced, it is described to produce module 1, to
Cell production sample is collected, and identity is increased by an internet-of-things terminal, is produced according to the identity is corresponding
Cell, the storage module 2, to provide the storage condition for the cell that reception is produced and be carried in management server after storage
The api interface accessed for a customer account management end, the transportation module 3, to ship the cell in the storage module, and passes through
One visualization terminal obtains the nodal information in transportation in real time.Cell life can be collected in the production module 1
Sample is produced, and increases the unique identities mark of the cell production sample by internet-of-things terminal.Unique identities mark has
Two kinds of functions：1. for carrying out identification to the operating personnel of device end production, pass through the verification operation people such as start that swipe the card
The qualification of member, it is ensured that the safe handling to device end.2. the cell collected production sample is made a distinction and data knot
Structureization processing.The storage condition of cell is provided in the storage module 2, while the data of storage are stored in management server
In.The management server provides the access interface at customer account management end, and storage data can be obtained by client-side management end,
Preferably data processing has been carried out in storage link.The mechanism of shipment cell is provide not only in the transportation module 3, together
The visual modes of Shi Caiyong realize controllable to each transit link.Transported in the defeated environment that the transportation module 3 has been taken, should
Transportation environment is controlled by transportation module this described 3, the immunocyte is can be used in transporting keeping its activity, stability or is kept away
Exempt to crack.In addition, said system dispose when also need to consider collection facility, transporting equipment, production district equipment, memory block equipment,
Examine experimental facilities, public office system etc..Secondly, need to cover from cell collection, separation, amplification, induction, sieve from the time
All stages such as choosing, storage, quality inspection, feedback human body, therapeutic effect assessment.Fig. 2 is refer to, as illustrated, production module 1
In internet-of-things terminal, identity, to cooperate and realize the control of identity marks and authority.In storage module 2
Client-side management end and management server, it is a kind of network structure pattern after WEB rises based on B/S patterns, web browser
It is the most important application software of client.This pattern has unified client, and the core that systemic-function is realized is focused on
On server, the exploitation, maintenance and use of system are simplified.As long as a browser, such as Netscape are installed in client computer
Navigator or Internet Explorer, server installation SQL Server, Oracle, MYSQL etc. database.Browser
Data interaction is carried out with database by Web Server.Visualization terminal in transportation module 3, can by PAD, mobile phone,
Rf terminal is carrier, carries out visual result output.
In certain embodiments, the specification for producing production operation in module 1 is to ensure that the crucial control of cell therapy curative effect
Link, for the whole production operation process of immune cell therapy product.
In certain embodiments, produce in module 1 and include but is not limited to, be related to peripheral blood collection, precursor PBMC
Separation, freeze and recover, external evoked culture, the culture purified of cell, passage culture.
In certain embodiments, produce in module 1 and include but is not limited to, the standard practice instructions that Binding experiment room has been established
(SOP), embedded configurable working solution stream, among various processes Process integration to system business process.
In certain embodiments, storage module 2 uses barcode label technology, effectively prevents production process from producing to obscure, and
Flow process is tracked online on this basis, it is ensured that personnel strictly perform operation according to SOP, and it is artificial poor to prevent as far as possible
It is wrong.
In certain embodiments, the content deposited in storage module 2 includes but is not limited to, and includes standard operation technique, production
The name of an article claims, production batch number, the date of manufacture, operator, review person, operation equipment, product quantity, batch packaging record and related
Key points for operation, emphasis operation review, the control of intermediate mass standard, plant maintenance and verification, abnormal conditions record and report.
Fig. 3 is refer to, as preferred in the present embodiment, the production module 1 includes：Collecting unit 11, identification
Unit 12, identity authentication unit 13, production equipment administrative unit 14, the collecting unit 11, to be adopted from cell derived place
Collection obtains cell sample, the identity recognizing unit 12, to identify the identity information of the cell sample, the identity authentication
Unit 13, to check that the identity information is to matching, the production equipment administrative unit 14, to call different production
Equipment carries out cell production.Identity information can be write in two-dimentional RF tag, Bluetooth label or NFC label, pass through identification
Corresponding label obtains the information of cell sample.It is in the label and read write line for refer to write-in to matching to check the identity information
Whether the label data deposited can match, and can not continue cell production if it can not match.Production equipment,
In cell therapy production link, the relevant device being related to is relatively more, and associated maintenance, cleaning, maintenance require stricter, and
And equipment has the characteristics that precision is high, the datamation unit realizes equipment prior art specification, spare part and consumable, fortune mostly
The Information sign of row condition；The daily operation conditions of equipment, usage record, association person liable；It is and regular according to GMP related specifications
Equipment cleaning, maintenance, checksum validation prompting are sent, and improves relative recording automatically.In addition improve and set for part api interface
Standby, such as cell counter, flow cytometer, microbial cultivation instrument, ELIASA, directly will inspections using appropriate interface scheme
Survey result to capture to system, and associated with batch sample, the important evidence let pass as product, reduce person works' amount, avoid
Artificial data inputting error.
Fig. 4 is refer to, as preferred in the present embodiment, the storage module 2 includes：Environment unit 21, flow management and control
Unit 22, quality management unit 23, the environment unit 21, to provide storage condition and relevant device, the flow pipe
Unit 22 is controlled, to establish the control of the flow nodes of standardized management, the quality management unit 23, to carry out quality guarantor
Card, quality monitoring and save file management.Include but is not limited in the environment unit 21, the sanitary cleaning of producing region
Cleanliness is verified or relevant environment monitoring of tools.Producing region health verifies periodic logging and accordingly verifies result, and fulfill one's duties people.
Environmental unit monitoring then mainly includes personal security associated monitoring, such as：The oxygen concentration monitoring of liquid nitrogen storage region, fire alarm prison
Control；Quality associated monitoring is also included, such as：Transportation temperature, the gas concentration lwevel and monitoring temperature of cell culture incubator are expensive
Weight or sensitive agents preserve epidemic disaster monitoring, the monitoring of Lab region epidemic disaster.Pass through related sensor module record data
Curve, preserve to system, and associated with corresponding product bath manufacturing records, recall for later product quality and analyze.In the stream
In journey control unit 22 include but is not limited to operation be, record inspection data, including institute inspection in need enter factory's material, try
Agent, packaging material, store sample for a long time, the detection data that product keeps sample.The defective work occurred to each stage is tracked, no
Qualified material, reagent can not be put into production, and subsequent processing can not be entered by abnormal link occur, not influence product quality
Under the premise of, it is continuing with to audit through related higher level director and ratifies, and does exception record.Wrapped in the quality management unit 23
The operation for including but being not limited to is audit of suppliers management, production process operating mode pattern, lot number tracking, defective work tracking, product
The setting of clearance condition, product quality variance analysis and total quality are looked back.Include but unlimited in the quality management unit 23
In save file management, in actual production for the relevant personnel in whole production process, process, manufacturer's facility, defend
Each quality management link such as carded sliver part, supplementary material and packaging material, standard operation, quality control is made that necessary regulation.Can
Drafting, revise, examine, ratify, cancel and preserve, recording enterprise's associated verification file for associated documents is realized, it is convenient to meet
The file that user's quick search of authority needs.
The quality management unit 23 is specifically referred to ensure that the sense of organization management that product/service quality is deployed controls row
For.The Quality situation during cell collection, transport, preparation, detection and storage is analyzed specific in the application,
And formulate the qualifying point of key link.
Specifically, in cell collection link, due to the problem of collection qualification rate is low be present, treating picker's case not
The problem of solution, later stage track the problem of unfavorable, it is necessary to increase corresponding control point in quality management unit 23, such as, to collection
Formulation standard, the case for treating picker actively carries out understanding verification, later stage follow-up is recorded.
In cell transit link, when reaching storage due to existing temperature cannot be guaranteed, transport that driver blocks up can not be timely
Reach, transport driver is unfamiliar with vehicle in route, transportation and occurs damaging, it is necessary in quality management unit 23 increase corresponding
Control point, such as, in-car set up the temperature control device of incubator and set alarm temperature, on haulage vehicle install GORS navigation,
Periodically need to change haulage vehicle.
Link is prepared in cell, damaged collection bag, collection bag title and data are not inconsistent, collection capacity is insufficient, adopt due to existing
There is the problem of pollution, rate of recovery fluctuation is big, it is necessary to increase corresponding control point in quality management unit 23 in collection moral integrity, operation,
For example the preceding inspection formulation standard of increase preparation, the increase of setting time point prepare preceding inspection, purchase full automatic preparation machine and supervise
Staff training in control data, increase group.
In cell freezing link, it is put into the problem of liquid nitrogen step is excessive due to sample be present, is detected without continuous liquid nitrogen
The shortcomings that warning device, then increase transfer container, the increase warning system of cell sample, setting report in quality management unit 23
Alert temperature, and be connected with the communication apparatus of equipment director.
In cell detection link, there is no the work for detecting cell before bacterium/mould detection, freezing are not carried out to finished product
Property, sample activity is influenceed by human factor, operational error makes testing result abnormal etc., then increase in quality management unit 23
Activity determination specified value, increase internal training and examination before detection, increase after preparation are frozen.
Fig. 5 is refer to, as preferred in the present embodiment, the transportation module 3 includes：It is classified delivery unit 31, transport
Environment unit 32, transport dispensing unit 33, the classification delivery unit 31 are thin after cell production sample, production to provide
Interface, the transportation environment unit 32, to provide different cells fortune are not transported in the classification of born of the same parents and production cell to be transported
The transport option interface of defeated environment, the transport dispensing unit 33, interface is configured to provide the transport of different stage transport.It is logical
Crossing above-mentioned classification and not transporting interface, transport option interface and transport configuration interface can be cell transport option and configure
Traffic condition the most suitable.Due to the commercialization of culture cell line (being), exchange, exchange and purchase between cell culture chamber
Turn into an important component in life science, cultivate the transport of cell as an important ring of research work
Section.If not knowing about the character of wanted cell, nutrient solution feature and culture points for attention, do not pay attention to using special container during transport
Or temperature etc., it is possible to influence the growth of cell, or go wrong, or cause culture unsuccessfully etc..
Specifically, the means of transportation first when the classification not transport interface provides cell production sample, such as, it is immune
Cell can first pass through a buffering area, and buffering area can avoid the formulation materials of immunocyte from producing excessive ring in transportation
Border difference.Preferably, in order to overcome the temperature fall of transport in buffering area, buffering area can inject the liquefaction state nitrogen of certain content with
Temperature is controlled, avoids the stem cell medicine material from producing unexpected influence because the temperature fall is excessive.Again for example, classification fortune
Also keeping temperature control, humidity are needed in defeated unit 31 to carry out temperature control, illumination control or the control of sterilizing degree, transportation environment
Control, illumination control or the control of sterilizing degree, the immunocyte is set to keep its activity, stability in way is transported or avoid splitting
Solution.The transportation environment in the transportation environment unit 32 is configured in certain embodiments：Freeze transport.Specifically, it is first
First it is placed in using dry ice (- 78 DEG C) in plastic foam box, processing is proper, can preserve 7-8 days.Once melting, cell is lived
Power will drastically decline.Secondly, cell cryopreservation tube is tightly wrapped up, plastic foam box used should be not less than 300 × 300 ×
300mm, the thickness of wall is about 50mm, and inner space is 200 × 200 × 200mm, and so big space need to be put into 5kg dry ice.So
Afterwards, cell is transferred in dry ice from liquid nitrogen with most fast speed, otherwise cell will be heated up with 10~20 DEG C/min speed.Definitely
Temperature can not be allowed to be higher than -50 DEG C.Finally after arriving at, you can routinely recovery is handled.
The transportation environment in the transportation environment unit 32 is configured in certain embodiments：Living cells transportation environment.
Specifically, first, cell should be in exponential phase early stage or mid-term, in good condition.If cell density is excessive, culture
Liquid can consume too fast, and cell is also easy to come off.Nutrient solution should be filled it up with, and tighten bottle cap, the shaking amplitude of such liquid would not
It is too big.Bottle cap edge tightly is tamping, blake bottle is wrapped up with packing.It can transport.Fragile article should be indicated on shipping label, is cut
The not printed words such as freezing.Secondly, after arriving at, most of nutrient solution can be outwelled, the nutrient solution of remaining normal amount continues to train
Support.When cell growth to nutrient solution when can pass on, renewed.Finally, nutrient solution should not more be renewed at once, in case cell is uncomfortable
Should.
Shipment cell in dispensing unit 33 is transported in certain embodiments to include but is not limited to：Stored frozen is transported.Freezing
Storage transport is to utilize the transportation resources that liquid nitrogen or dry ice are contained in special container.
Shipment cell in dispensing unit 33 is transported in certain embodiments to include but is not limited to：Topping up method, is typically chosen life
Long good cell, it is advisable with growing 1/3~1/2 bottom of bottle wall, removes old nutrient solution, is supplemented new nutrient solution to neck part, protect
Micro-air is stayed, bottle cap is tightened, the sealing of blend compounds band, is placed in a transport box, shockproof processing against pressure is done with cotton etc..
If haulage time needs 4~5 days, personal pocket is generally placed upon, unnecessary nutrient solution is poured out after arriving at,
It need to only retain and maintain the nutrient solution needed for growth to put 37 DEG C of cultures, next day passage.
If in intra-urban transportation or only needing a few hours to transport distance, cell can also be adhered to it is face-up, or nutrient solution whole
Outwell and be placed on chest pocket transport.Nutrient solution by being attached to cell surface, can be such that the cell short time is not damaged.
Transport in certain embodiments in dispensing unit 33, topping up method uses Ficoll400 separating liquids.
Fig. 6-7 are refer to, as preferred in the present embodiment, the system in the present embodiment includes：Produce module 1, storage
Module 2 and transportation module 3, further comprises labor management module 4, the labor management module 4, including：Productive manpower management
Port 41, transport labor management port 42, collection source labor management port 43, equipment labor management port 44, environment are manually managed
Port 45 is managed, the productive manpower management port 41, to provide production process labor management service interface, the transport is artificial
Management port 42, to provide transportation labor management service interface, the collection source labor management port 43, to provide
Collection source labor management service interface, 44 mouthfuls of the equipment labor management end, to provide production, storage and transporting equipment
Labor management service interface, the environment labor management port 45, to provide the artificial pipe of production, storage and transportation environment
Manage service interface.Labor management includes but is not limited to, the clinician of hospital, transportation and packing；The transport people of transporter；Production is real
Test reception person, laboratory technician, storage original, the auditor of room；The personnel such as the material monitoring of Quality Mgmt Dept, process monitoring, file management；If
Standby management, environmental management, system manager etc..
Fig. 8 is refer to, as preferred in the present embodiment, the system in the present embodiment includes：Produce module 1, storage mould
Block 2 and transportation module 3, in addition to：Clinography unit 5, to assess cell therapy effect and feedback cell service condition,
The clinography unit, in order to assess cell therapy effect, feeds back with the data syn-chronization clinography list 5 in management server
The module of cell service condition.
For example clinography is treated for autoimmune cell DC, CIK, clinography unit 5 is mainly covered：
Cell therapy informed consent form；
Patient's ordinary circumstance information, including sex, age, clinical diagnosis, pathological diagnosis, medical history, testing result, life matter
Amount scoring, other treatment or administration record；
Cell therapy records, including treatment time, cell therapy protocols (immune cell types, method of administration), cell are defeated
Indegree, reacting and handling occur in the treatment in input cell quantity, patient every time；
Therapeutic effect assess record, such as pretherapy and post-treatment different time sections conditions of patients change, mainly including tumor size,
Tumor markers change, immunologic function indication, quality of life change, life cycle etc., synthesis are assessed therapeutic effect.The portion
Member record can pass through school's clinical electronic medical record system interface by clinical treatment doctor or blood collection nurse's typing, partial data
API is captured, and feeds back to the management information system in the present embodiment.
As shown in figure 9, in another embodiment in this application, there is provided a kind of pipe for the transport of cell production inventory
Reason method, comprises the following steps：
Step S100 collects cell production sample, and increases identity by an internet-of-things terminal, according to described
Identity correspondingly produces cell,
Step S101 provides the storage condition for receiving the cell produced and provides a visitor after being stored in management server
The api interface that family management end accesses,
Step S102 ships the cell in the storage module, and is obtained in real time in transportation by a visualization terminal
Nodal information.
In certain embodiments, above-mentioned steps S100 also includes：
Cell sample is collected from cell derived place,
The identity information of the cell sample is identified,
Check the identity information be to matching,
Different production equipments is called to carry out cell production.
In certain embodiments, above-mentioned steps S101 also includes：
The environment unit, to provide storage condition and relevant device,
The flow nodes control of standardized management is established,
Carry out quality assurance, quality monitoring and save file management.
In certain embodiments, above-mentioned steps S102 also includes：
The classification for providing cell and production cell to be transported after cell production sample, production does not transport interface,
The transport option interface of different cell transportation environments is provided,
The transport configuration interface of different stage transport is provided.
As preferred in the present embodiment, also include in above-mentioned steps：
Production process labor management service interface is provided,
Transportation labor management service interface is provided,
Collection source labor management service interface is provided,
The labor management service interface of production, storage and transporting equipment is provided,
The labor management service interface of production, storage and transportation environment is provided.
As preferred in the present embodiment, also include in above-mentioned steps：Assess cell therapy effect and feedback cell uses
Situation, the clinography unit and the data syn-chronization in management server.
In certain embodiments, the internet-of-things terminal includes：Based on NFC, bluetooth, RF radio frequencies, Zigbee radio communications
The terminal of agreement.
In certain embodiments, the visualization terminal includes：Visualization window based on HTML5/touch window.
In certain embodiments, management server includes web server, database and apps server.
As shown in Figure 10, in another embodiment in this application, there is provided a kind of management server, including：
The management request of Web server is received, the management request comprises at least：Cell production sample is collected, and
Identity is increased by an internet-of-things terminal, cell is correspondingly produced according to the identity,
The storage condition for receiving the cell produced is provided and provides a customer account management end after being stored in management server
The api interface of access,
The cell in the storage module is shipped, and the node in transportation is obtained by a visualization terminal in real time and believed
Breath,
Above-mentioned request provides the approach for accessing cell production inventory and transporting to browser by apps server, for
Subscription client application program uses.
It should be appreciated that each several part of the present invention can be realized with hardware, software, firmware or combinations thereof.Above-mentioned
In embodiment, software that multiple steps or method can be performed in memory and by suitable instruction execution system with storage
Or firmware is realized.If, and in another embodiment, can be with well known in the art for example, realized with hardware
Any one of row technology or their combination are realized：With the logic gates for realizing logic function to data-signal
Discrete logic, have suitable combinational logic gate circuit application specific integrated circuit, programmable gate array (PGA), scene
Programmable gate array (FPGA) etc..
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specifically show
The description of example " or " some examples " etc. means specific features, structure, material or the spy for combining the embodiment or example description
Point is contained at least one embodiment or example of the present invention.In this manual, to the schematic representation of above-mentioned term not
Necessarily refer to identical embodiment or example.Moreover, specific features, structure, material or the feature of description can be any
One or more embodiments or example in combine in an appropriate manner.
In general, the various embodiments of the disclosure can be with hardware or special circuit, software, logic or its any combination
Implement.Some aspects can be implemented with hardware, and some other aspect can be with firmware or software implementation, and the firmware or software can
With by controller, microprocessor or other computing devices.Although the various aspects of the disclosure be shown and described as block diagram,
Flow chart is represented using some other drawing, but it is understood that frame described herein, equipment, system, techniques or methods can
With in a non limiting manner with hardware, software, firmware, special circuit or logic, common hardware or controller or other calculating
Equipment or some combinations are implemented.
Although in addition, operation is described with particular order, this is understood not to require this generic operation with shown suitable
Sequence is performed or performed with generic sequence, or requires that all shown operations are performed to realize expected result.In some feelings
Under shape, multitask or parallel processing can be favourable.Similarly, begged for although the details of some specific implementations is superincumbent
By comprising but these are not necessarily to be construed as any restrictions to the scope of the present disclosure, but the description of feature is only pin in
To specific embodiment.Some features described in some embodiments of separation can also be held in combination in single embodiment
OK.Mutually oppose, the various features described in single embodiment can also in various embodiments be implemented separately or to appoint
The mode of what suitable sub-portfolio is implemented.
Claims (10)
- A kind of 1. management system for the transport of cell production inventory, it is characterised in that including：Produce module, storage module with And transportation module,The production module, to collect cell production sample, and identity is increased by an internet-of-things terminal, according to The identity correspondingly produces cell,The storage module, to provide the storage condition for the cell that reception is produced and be provided in management server after storage The api interface that one customer account management end accesses,The transportation module, to ship the cell in the storage module, and transport is obtained by a visualization terminal in real time During nodal information.
- 2. management system according to claim 1, it is characterised in that the production module includes：Collecting unit, identity are known Other unit, identity authentication unit, production equipment administrative unit,The collecting unit, to collect cell sample from cell derived place,The identity recognizing unit, to identify the identity information of the cell sample,The identity authentication unit, to check the identity information be to matching,The production equipment administrative unit, to call different production equipments to carry out cell production.
- 3. management system according to claim 1, it is characterised in that the storage module includes：Environment unit, flow pipe Unit, quality management unit are controlled,The environment unit, to provide storage condition and relevant device,The flow management and control unit, to establish the control of the flow nodes of standardized management,The quality management unit, to carry out quality assurance, quality monitoring and save file management.
- 4. management system according to claim 1, it is characterised in that the transportation module includes：It is classified delivery unit, fortune Defeated environment unit, transport dispensing unit,The classification delivery unit, to provide the cell after cell production sample, production and produce cell to be transported Classification does not transport interface,The transportation environment unit, to provide the transport option interface of different cell transportation environments,The transport dispensing unit, interface is configured to provide the transport of different stage transport.
- 5. management system according to claim 1, it is characterised in that also include：Labor management module, the labor management Module includes：Productive manpower management port, transport labor management port, collection source labor management port, equipment labor management end Mouth, environment labor management port,The productive manpower management port, to provide production process labor management service interface,The transport labor management port, to provide transportation labor management service interface,The collection source labor management port, to provide collection source labor management service interface,The equipment labor management port, to provide the labor management service interface of production, storage and transporting equipment,The environment labor management port, to provide the labor management service interface of production, storage and transportation environment.
- 6. management system according to claim 1, it is characterised in that also include：Clinography unit, to assess cell Therapeutic effect and feedback cell service condition, the clinography unit and the data syn-chronization in management server.
- 7. according to the management system described in any one of claim 1-6, it is characterised in that the internet-of-things terminal includes：It is based on NFC, bluetooth, RF radio frequencies, the terminal of Zigbee wireless communication protocols.
- 8. according to the management system described in any one of claim 1-6, it is characterised in that the visualization terminal includes：It is based on HTML5 visualization window/touch window.
- 9. a kind of management method for the transport of cell production inventory, it is characterised in that comprise the following steps：Cell production sample is collected, and identity is increased by an internet-of-things terminal, it is corresponding according to the identity Produce cell,The storage condition for receiving the cell produced is provided and provides customer account management end access after being stored in management server Api interface,The cell in the storage module is shipped, and obtains the nodal information in transportation in real time by a visualization terminal.
- A kind of 10. management server, it is characterised in that including：The management request of Web server is received, the management request comprises at least：Cell production sample is collected, and is passed through One internet-of-things terminal increases identity, and cell is correspondingly produced according to the identity,The storage condition for receiving the cell produced is provided and provides customer account management end access after being stored in management server Api interface,The cell in the storage module is shipped, and obtains the nodal information in transportation in real time by a visualization terminal,Above-mentioned request provides the approach for accessing cell production inventory and transporting to browser by apps server, for user Client application uses.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109560893A (en) * | 2018-11-08 | 2019-04-02 | 中国联合网络通信集团有限公司 | Data verification method, device and server |
| CN110484448A (en) * | 2019-09-18 | 2019-11-22 | 杭州捷诺飞生物科技股份有限公司 | Biological tissue's process units |
| CN110890147A (en) * | 2019-11-19 | 2020-03-17 | 唐山启奥科技股份有限公司 | Perinatal period hematopoietic stem cell management system and transmission flow system |
| CN110910081A (en) * | 2018-09-17 | 2020-03-24 | 上海宝信软件股份有限公司 | Workflow configuration implementation method and system based on laboratory information management system |
| CN113110329A (en) * | 2021-04-14 | 2021-07-13 | 深圳赛动生物自动化有限公司 | Parallel operation control method, device, system and medium based on stem cell preparation |
| CN113361918A (en) * | 2021-06-04 | 2021-09-07 | 北京百奥利盟软件技术有限公司 | Production scheduling method in cell gene therapy industry |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070185751A1 (en) * | 2006-01-11 | 2007-08-09 | Dempers Ramon J | Drug life cycle management system |
| CN105117817A (en) * | 2015-07-27 | 2015-12-02 | 上海原能细胞医学技术有限公司 | Biological sample library application management system |
| CN105469179A (en) * | 2014-09-11 | 2016-04-06 | 深圳华大基因研究院 | Informationalized bio-sample library management system and sample management method |
| CN105825457A (en) * | 2016-03-16 | 2016-08-03 | 宁波市江东精诚自动化设备有限公司 | RFID blood management system |
-
2017
- 2017-09-19 CN CN201710851796.5A patent/CN107590632A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070185751A1 (en) * | 2006-01-11 | 2007-08-09 | Dempers Ramon J | Drug life cycle management system |
| CN105469179A (en) * | 2014-09-11 | 2016-04-06 | 深圳华大基因研究院 | Informationalized bio-sample library management system and sample management method |
| CN105117817A (en) * | 2015-07-27 | 2015-12-02 | 上海原能细胞医学技术有限公司 | Biological sample library application management system |
| CN105825457A (en) * | 2016-03-16 | 2016-08-03 | 宁波市江东精诚自动化设备有限公司 | RFID blood management system |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110910081A (en) * | 2018-09-17 | 2020-03-24 | 上海宝信软件股份有限公司 | Workflow configuration implementation method and system based on laboratory information management system |
| CN109560893A (en) * | 2018-11-08 | 2019-04-02 | 中国联合网络通信集团有限公司 | Data verification method, device and server |
| CN109560893B (en) * | 2018-11-08 | 2022-04-15 | 中国联合网络通信集团有限公司 | Data verification method and device and server |
| CN110484448A (en) * | 2019-09-18 | 2019-11-22 | 杭州捷诺飞生物科技股份有限公司 | Biological tissue's process units |
| CN110890147A (en) * | 2019-11-19 | 2020-03-17 | 唐山启奥科技股份有限公司 | Perinatal period hematopoietic stem cell management system and transmission flow system |
| CN113110329A (en) * | 2021-04-14 | 2021-07-13 | 深圳赛动生物自动化有限公司 | Parallel operation control method, device, system and medium based on stem cell preparation |
| CN113110329B (en) * | 2021-04-14 | 2023-01-10 | 深圳赛动智造科技有限公司 | Parallel operation control method, device, system and medium based on stem cell preparation |
| CN113361918A (en) * | 2021-06-04 | 2021-09-07 | 北京百奥利盟软件技术有限公司 | Production scheduling method in cell gene therapy industry |
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