CN112666362A - Automatic detection system suitable for large-scale production of biological medicines - Google Patents
Automatic detection system suitable for large-scale production of biological medicines Download PDFInfo
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- CN112666362A CN112666362A CN202011403867.3A CN202011403867A CN112666362A CN 112666362 A CN112666362 A CN 112666362A CN 202011403867 A CN202011403867 A CN 202011403867A CN 112666362 A CN112666362 A CN 112666362A
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Abstract
The invention relates to the technical field of large-scale production of biological medicines, in particular to an automatic detection system suitable for large-scale production of biological medicines, which comprises a detection sample feeding unit, a detection sample operation robot unit, a detection reagent liquid operation unit, a detection reagent storage unit, a detection instrument equipment unit, an automatic waste collection unit, an equipment purification and disinfection unit and an intelligent comprehensive control system unit, wherein the full-automatic detection system is designed so as to greatly improve the efficiency of biological medicine detection and meet the requirements of high-throughput research and development and production; the reliability of the detection result is improved; the detection performance of high uniformity is convenient to form a unity, and a large amount of detection standards are convenient to deploy; the space utilization rate can be effectively improved, the method is more suitable for being combined with the large-scale production of biological medicines, and the space occupation of the whole-flow production process is greatly reduced; the layout can be adjusted at any time according to the requirements of customers while the cost is reduced, and the system has practicability and economy.
Description
Technical Field
The invention relates to the technical field of large-scale production of biological medicines, in particular to an automatic detection system suitable for large-scale production of biological medicines.
Background
Biological medicine is in the rapid development stage, novel cellular immune medicines such as CAR-T, TCR-T are about to put into large-scale use, traditional manual detection mode is difficult to satisfy the industrialized mass production of the cellular immune medicine that comes about, in traditional manual detection operation process, the inspector need record a large amount of sample traceability data, and relevant traceability data can ' T be directly correlated with production system data center, and the mistake of manual record very easily appears, the biggest drawback of traditional manual detection is in can ' T realize quick automatic detection, can ' T respond the production demand fast in a large amount of novel cellular immune medicine production processes, manual operation mode homogeneity is difficult to guarantee between different operating personnel simultaneously, the operation that needs high homogeneity satisfies unified detection standard.
In summary, the present invention solves the existing problems by designing an automated detection system suitable for mass production of biopharmaceuticals.
Disclosure of Invention
The present invention is directed to an automated testing system for mass production of biopharmaceuticals, which solves the above problems.
In order to achieve the purpose, the invention provides the following technical scheme:
the utility model provides an automatic detecting system suitable for bio-pharmaceuticals large-scale production, includes automatic detecting system, automatic detecting system is including detecting sample material loading unit, detection sample operation robot unit, detect reagent liquid operation unit, detect reagent memory cell, detecting instrument equipment unit, discarded object automatic collection unit, equipment purification disinfection unit and intelligent integrated control system unit.
Preferably, the specific steps of the detection sample feeding unit are as follows: and automatically or semi-automatically placing the sample to be detected to a specific position, namely finishing the sample loading of the detected sample.
Preferably, the operation of the robot unit for detecting a sample comprises the following specific steps: and transferring the sample to be detected to a specific position to participate in complex liquid sample preparation work.
Preferably, the liquid operation unit for detecting reagents comprises the following specific steps: transferring a detection reagent sample liquid, and preparing a sample, wherein the preparing operation of the sample comprises disposable sample pipetting; pumping cleaning liquid; uniformly mixing sample liquid; and incubating the sample liquid, separating the sample liquid and purifying.
Preferably, the detection reagent storage unit comprises the following specific steps: the detection reagent refrigeration storage comprises refrigeration liquid for providing 12-24 channels and normal-temperature preservation liquid for providing 12-24 channels.
Preferably, the specific steps of the detection instrument and equipment unit are as follows: performing a detection analysis of a sample, wherein a detection unit is configured on the detection analysis of the sample, the detection unit comprising: a flow cytometer; an image observation unit; a count/activity rate determination unit; biochemical index unit and QPCR and microplate reader.
Preferably, the waste automatic collection unit comprises the specific steps of collecting waste generated in the sample detection process.
Preferably, the specific step of the apparatus decontamination and disinfection unit provides a disinfection function for the interior of the detection system space.
Preferably, the intelligent integrated control system unit is responsible for automatic scheduling, data acquisition and uploading of the detection system.
Compared with the prior art, the invention has the beneficial effects that:
1. in the invention, the full-automatic detection system is designed, so that the efficiency of biological medicine detection is greatly improved, and the requirements of high-throughput research and development and production are met; human factor influence is eliminated as much as possible, and the reliability of the detection result is improved; the detection performance of high uniformity is convenient to form a unity, and a large amount of detection standards are convenient to deploy; the space utilization rate can be effectively improved, the method is more suitable for being combined with the large-scale production of biological medicines, and the space occupation of the whole-flow production process is greatly reduced; can reduce the cost, adjust the layout at any time according to the requirements of customers, has practicability and economy, collects, stores and analyzes the GMP compliance full-flow data, realizes the comprehensive data application, thereby solving the problem that the traditional manual detection mode is difficult to meet the industrial scale production of the forthcoming cellular immune drugs, in the traditional manual detection operation process, detection personnel need to record a large amount of sample traceability data, the related traceability data can not be directly associated with the production system data center, and the manual recording error is easy to occur, the biggest defect of the traditional manual detection is that the rapid automatic detection can not be realized, the production requirement can not be quickly responded in the production process of a large amount of novel cellular immune drugs, meanwhile, the uniformity of a manual operation mode among different operators is difficult to guarantee, and the operation with high uniformity is required to meet the problem of unified detection standard.
Drawings
FIG. 1 is a block diagram of the overall system of the present invention;
FIG. 2 is a schematic diagram of the workflow of the present invention;
FIG. 3 is a schematic diagram of an axial structure of the system of the present invention.
In the figure: the system comprises a 1-detection sample feeding unit, a 2-detection sample operation robot unit, a 3-detection reagent liquid operation unit, a 4-detection reagent storage unit, a 5-detection instrument equipment unit, a 6-waste automatic collection unit, a 7-equipment purification and disinfection unit, an 8-intelligent comprehensive control system unit and a 101-automatic detection system.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments, and all other embodiments obtained by a person of ordinary skill in the art without creative efforts based on the embodiments of the present invention belong to the protection scope of the present invention.
Referring to fig. 1-3, the present invention provides a technical solution:
the utility model provides an automatic detecting system suitable for bio-pharmaceuticals large-scale production, includes automatic detecting system 101, automatic detecting system 101 is including detecting sample material loading unit 1, detection sample operation robot unit 2, detect reagent liquid operation unit 3, detect reagent storage unit 4, detecting instrument equipment unit 5, discarded object automatic collection unit 6, equipment purification disinfection unit 7 and intelligent integrated control system unit 8.
Further, the specific steps of detecting the sample feeding unit 1 are as follows: and automatically or semi-automatically placing the sample to be detected to a specific position, namely finishing the sample loading of the detected sample.
Further, the specific steps of the sample detection operation robot unit 2 are as follows: and transferring the sample to be detected to a specific position to participate in complex liquid sample preparation work.
Further, the specific steps of the detection reagent liquid operation unit 3 are as follows: transferring a detection reagent sample liquid, and preparing a sample, wherein the preparing operation of the sample comprises disposable sample pipetting; pumping cleaning liquid; uniformly mixing sample liquid; and incubating the sample liquid, separating the sample liquid and purifying.
Further, the specific steps of the detection reagent storage unit 4 are as follows: the detection reagent is stored in a refrigerating mode, and the detection reagent is stored in the refrigerating mode and comprises refrigerating liquid for providing 12-24 channels and normal-temperature preservation liquid for providing 12-24 channels.
Further, the specific steps of the detection instrument device unit 5 are as follows: performing a detection analysis of the sample, wherein a detection unit is configured on the detection analysis of the sample, the detection unit comprising: a flow cytometer; an image observation unit; a count/activity rate determination unit; biochemical index unit and QPCR and microplate reader.
Further, the automatic waste collection unit 6 is configured to collect waste generated during the sample testing process.
Further, the specific steps of the device decontamination and disinfection unit 7 provide disinfection functions for the interior of the detection system space.
Further, the intelligent integrated control system unit 8 specifically performs the steps of automatic scheduling, data acquisition and uploading of the detection system.
The specific implementation case is as follows:
as shown in fig. 1, 2 and 3, in step 1, the sample to be detected is automatically or semi-automatically placed at a specific position by the sample feeding unit 1, and then the sample feeding of the sample to be detected is completed;
1) firstly, transferring a detection sample into detection tubes for various types of detection items;
2) secondly, cleaning and purifying the samples in the detection tubes;
3) then, adding corresponding detection reagents into each detection tube;
4) finally, uniformly mixing all the detection tubes, and incubating;
step 5, the detection instrument unit 5 performs detection analysis of the sample, wherein a detection unit is configured on the detection analysis of the sample, and the detection unit includes: a flow cytometer; an image observation unit; a count/activity rate determination unit; the biochemical index unit, the QPCR and the enzyme-linked immunosorbent assay device specifically comprise the following components:
1) firstly, transferring each detection tube to corresponding detection equipment;
2) secondly, detecting a sample by using detection equipment;
and 6, collecting the waste generated in the sample detection process by the automatic waste collecting unit 6.
Step 7, the equipment purification and disinfection unit 7 detects that the interior of the system space provides a disinfection function;
1) sample data of each detection tube is transmitted to the intelligent integrated control system unit 8;
2) the intelligent integrated control system unit 8 carries out intelligent identification and judgment on the detection result.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (9)
1. The utility model provides an automatic detecting system suitable for biological medicine large-scale production, includes automatic detecting system (101), its characterized in that, automatic detecting system (101) is including detecting sample material loading unit (1), detection sample operation robot unit (2), detect reagent liquid operating element (3), detect reagent memory cell (4), detecting instrument equipment unit (5), discarded object automatic collection unit (6), equipment purification disinfection unit (7) and intelligent integrated control system unit (8).
2. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the detection sample feeding unit (1) comprises the following specific steps: and automatically or semi-automatically placing the sample to be detected to a specific position, namely finishing the sample loading of the detected sample.
3. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the detection sample operation robot unit (2) comprises the following specific steps: and transferring the sample to be detected to a specific position to participate in complex liquid sample preparation work.
4. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the detection reagent liquid operation unit (3) comprises the following specific steps: transferring a detection reagent sample liquid, and preparing a sample, wherein the preparing operation of the sample comprises disposable sample pipetting; pumping cleaning liquid; uniformly mixing sample liquid; and incubating the sample liquid, separating the sample liquid and purifying.
5. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the detection reagent storage unit (4) comprises the following specific steps: the detection reagent refrigeration storage comprises refrigeration liquid for providing 12-24 channels and normal-temperature preservation liquid for providing 12-24 channels.
6. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the specific steps of the detection instrument equipment unit (5) are as follows: performing a detection analysis of a sample, wherein a detection unit is configured on the detection analysis of the sample, the detection unit comprising: a flow cytometer; an image observation unit; a count/activity rate determination unit; biochemical index unit and QPCR and microplate reader.
7. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the automatic waste collection unit (6) comprises the specific steps of collecting waste generated in the sample detection process.
8. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the specific steps of the equipment purification and disinfection unit (7) provide disinfection functions for the interior of the detection system space.
9. The automated testing system of claim 1, wherein the automated testing system is adapted for mass production of biopharmaceuticals, and comprises: the intelligent integrated control system unit (8) is responsible for automatic scheduling, data acquisition and uploading of the detection system.
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| CN202011403867.3A CN112666362A (en) | 2020-12-03 | 2020-12-03 | Automatic detection system suitable for large-scale production of biological medicines |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103370616A (en) * | 2010-10-29 | 2013-10-23 | 恩姆菲舍尔科技公司 | Automated system for sample preparation and analysis |
| CN109207366A (en) * | 2018-11-22 | 2019-01-15 | 英诺维尔智能科技（苏州）有限公司 | A kind of cell culture automatic equipment |
| CN109486655A (en) * | 2018-12-27 | 2019-03-19 | 英诺维尔智能科技（苏州）有限公司 | A kind of full-automation biological products system |
| CN110438003A (en) * | 2019-08-30 | 2019-11-12 | 英诺维尔智能科技（苏州）有限公司 | A kind of big batch cell products large-scale production system |
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- 2020-12-03 CN CN202011403867.3A patent/CN112666362A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103370616A (en) * | 2010-10-29 | 2013-10-23 | 恩姆菲舍尔科技公司 | Automated system for sample preparation and analysis |
| CN109207366A (en) * | 2018-11-22 | 2019-01-15 | 英诺维尔智能科技（苏州）有限公司 | A kind of cell culture automatic equipment |
| CN109486655A (en) * | 2018-12-27 | 2019-03-19 | 英诺维尔智能科技（苏州）有限公司 | A kind of full-automation biological products system |
| CN110438003A (en) * | 2019-08-30 | 2019-11-12 | 英诺维尔智能科技（苏州）有限公司 | A kind of big batch cell products large-scale production system |
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Application publication date: 20210416 |