CN216916398U - Automatic filling equipment of high flux stem cell preparation - Google Patents
Automatic filling equipment of high flux stem cell preparation Download PDFInfo
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- CN216916398U CN216916398U CN202221231764.8U CN202221231764U CN216916398U CN 216916398 U CN216916398 U CN 216916398U CN 202221231764 U CN202221231764 U CN 202221231764U CN 216916398 U CN216916398 U CN 216916398U
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Abstract
The utility model discloses automatic filling equipment for a high-flux stem cell preparation, which comprises a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a gas communicating vessel, a centrifugal cup, a transfer bag, a first cell filter screen, a waste liquid bag, a product bag and a first pipeline; the first pipeline is respectively connected with a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a gas communicating vessel, a centrifugal cup, a transfer bag, a waste liquid bag and a product bag; the first pipe clamp is arranged at the joint of the first pipeline and each container, so that the communication or the closing between the first pipeline and each container is controlled; one end of the first cell filter screen is connected with the first pipeline, and the other end of the first cell filter screen is connected with the transfer bag. The utility model connects the operations of washing and centrifuging, uniformly mixing and preparing, multi-agent filling and the like of the stem cells in series to form a closed filling system, thereby realizing the automatic filling of the stem cell preparation. Compared with manual operation, the utility model reduces the technical difficulty of operation and improves the filling efficiency.
Description
Technical Field
The utility model belongs to the technical field of biological medicines, and particularly relates to automatic filling equipment for a high-flux stem cell preparation.
Background
In 2017, the national drug evaluation center promulgated "guidelines (trial) for research and evaluation of cell therapy products", which indicates that stem cell products can be clinically tested according to drugs.
The current development of stem cell products/medicines mainly comprises two directions, one is a fresh preparation prepared at present, and the other is a frozen preparation which is directly used after recovery. The current operations are all realized by manual operations, and according to the requirements of GMP, the operations are filled bag by bag in A-level environment under B-level background.
The production process of the fresh preparation comprises the steps of cell resuscitation of a working cell bank, washing and centrifugation, uniform mixing preparation, multi-dose filling and the like, generally, the batch is small, the effective period is short (less than or equal to 24 hours), but according to the requirement of sterile inspection of Chinese pharmacopoeia, the whole detection period needs about 2 weeks by adopting a membrane filtration method, and the development and clinical test of stem cell products are seriously restricted by the sterile inspection of the stem cell products. Therefore, developers of stem cell products in the current market develop a sterile rapid detection method on one hand, and develop a closed filling method of the stem cell products on the other hand, so that the check time point of the sterile detection is advanced to a cell bank stage to meet the regulatory requirements of the stem cell products. In addition, the manual operation also has the problem of poor batch-to-batch consistency.
The production of the frozen preparation comprises the steps of washing and centrifuging the harvested cells, uniformly mixing and preparing, filling a plurality of preparations, freezing and storing and the like, and the batch is large. At present, the production of the frozen preparation formulation mainly depends on manual operation, multiple persons and multiple devices are required to operate simultaneously, and the production is complicated and consumes long time; and the consistency between batches is poor, the requirement on sterility guarantee is high, the risk of microbial contamination is high, the standardization is difficult, and the method is contradictory to the commercial production of the medicines.
At present, the high-throughput, closed and automatic subpackaging systems aiming at cell products in the market are few, and commonly used cell processing systems such as BioSafa Sepax 2 and CellSep are adopted. However, these packaging systems are designed mainly for hematopoietic stem cells or immune cells, and are all designed for individual single-donor cell products, and the packaging treatment of large-scale cell preparations is not considered; and the final product only has one bag, and can not be subpackaged by a plurality of bags.
Before stem cell products are filled, generally, the feeding amount of each batch is relatively fixed and large, multiple doses are needed for filling, and the existing equipment and process cannot meet the requirements of high-throughput and automatic production of the stem cell products.
SUMMERY OF THE UTILITY MODEL
In order to solve the technical problems, the high-throughput and automatic production requirements of stem cell products are met, the production efficiency of stem cells is improved, and the labor intensity of technicians is reduced.
The utility model provides automatic filling equipment for a high-flux stem cell preparation, which comprises a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a centrifugal cup, a transfer bag, a first cell filter screen, a waste liquid bag, a product bag and a first pipeline;
the first pipeline is respectively connected with a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a centrifugal cup, a transfer bag, a waste liquid bag and a product bag;
the first pipe clamp is arranged at the joint of the first pipeline and each container and is used for controlling the communication or closing between the first pipeline and each container;
one end of the first cell filter screen is connected with the first pipeline, and the other end of the first cell filter screen is connected with the transfer bag.
Preferably, the first cell strainer is used to remove larger cell clumps from the stem cell preparation so that the stem cell product remains well homogenous. The upper end of the first cell filter screen is connected with the first pipeline, and the lower end of the first cell filter screen is connected with the top end of the transfer bag.
In addition, a second pipeline connected with the first cell filter screen in parallel is arranged beside the first cell filter screen, the lower end of the second pipeline is connected with the top end of the transfer bag, and the upper end of the second pipeline is connected with the first pipeline.
Preferably, the first cell strainer has a mesh diameter of 40-100 μm, and may be any value within the above range, such as 40, 45, 50, 52, 55, 58, 60, 62, 66, 70, 75, 80, 83, 88, 90, 93, 95, 98, 100 μm, and the like.
In one embodiment of the present invention, the transfer bag is used primarily to adjust the cell content of the stem cell preparation product, and a sampling port is provided in the lower sidewall of the transfer bag. And collecting a stem cell liquid sample in the transfer bag through a sampling port, and then counting the cell content, thereby providing technical support for regulating and controlling the quality of a stem cell preparation product. In order to control the liquid in and out of the transfer bag, a third pipe clamp is arranged between the first cell filter screen and the transfer bag, and a second pipe clamp is arranged between the second pipeline and the transfer bag. When the second pipe clamp is closed and the third pipe clamp is opened, the stem cell preparation can enter the transfer bag after passing through the first cell filter screen; when the second pipe clamp is opened and the third pipe clamp is closed, the stem cell preparation in the transfer bag can enter the first pipeline from the transfer bag and then be sequentially input into the centrifuge cup and the product bag as required.
Preferably, the raw material tank/bag, the auxiliary tank/bag and the cleaning liquid tank/bag are respectively connected with the first pipeline through puncture needles.
More preferably, a second cell filter screen is arranged between the puncture needle at the lower end of the raw material tank/bag and the first pipe clamp, so that the stem cell liquid in the raw material tank/bag enters the first pipeline, the centrifugal cup, the first cell filter screen and the transfer bag in sequence after being filtered. And then collecting a stem cell liquid sample from the sampling port for counting, adjusting the amount of the added auxiliary materials according to the counting result, and determining the cell content in the final stem cell product.
Preferably, the second cell strainer is used to remove cell clumps from the stem cell liquid entering the first tubing from the feed tank/bag so that the stem cell product remains well homogenous.
Preferably, the diameter of the second cell strainer mesh is 40-100 μm, and may be any value within the above range, such as 40, 45, 50, 52, 55, 58, 60, 62, 66, 70, 75, 80, 83, 88, 90, 93, 95, 98, 100 μm, and the like.
In one embodiment of the utility model, the centrifuge cup is used for centrifugal purification of stem cell liquid to remove impurities. In addition, the centrifugal cup can also mix stem cell liquid and auxiliary materials, so that the blending of stem cell preparation products is completed. In order to provide power for the stem cell liquid to enter and exit the centrifuge cup, a peristaltic pump is arranged between the upper end of the centrifuge cup and the first pipe clamp, the amount of the liquid entering and exiting the centrifuge cup can be accurately controlled through the peristaltic pump, and technical support is provided for the subsequent filling of product bags.
Preferably, the number of the product bags in the automatic filling equipment is multiple, and the specific number can be determined according to the amount of the stem cell liquid filled in each batch and the capacity of each product bag. In order to facilitate the exchange of the product bags, a product filling and dispensing station is provided on the conduit between the product bag and said first line. Each branch pipe on the distribution station can be controlled to be opened or closed through a first pipe clamp or a valve.
In one embodiment of the utility model, the automatic filling equipment comprises at least one auxiliary material tank/bag, and the number of the specific auxiliary material tanks/bags is determined according to the type of the auxiliary material to be added. For example, two auxiliary material tanks/bags A and two auxiliary material tanks/bags B can be arranged, wherein the auxiliary material A and the auxiliary material B are both buffer solutions and are mainly used for cell resuspension. At least one cleaning liquid tank/bag is arranged, the number of the specific cleaning liquid tanks/bags is determined according to the type of the cleaning liquid, and the cleaning liquid is mainly used for washing the cell suspension for multiple times so as to remove impurities in the cell suspension.
Preferably, the automatic filling equipment further comprises a gas communicating vessel connected to the first pipeline for adjusting the air pressure balance between the first pipeline and the outside, so as to ensure that the liquid between the first pipeline and each container flows smoothly.
Preferably, the pipeline in the automatic filling equipment is latex tube, silicone tube or PVC tube capable of sterilizing, and further preferably is silicone tube.
The utility model has the technical effects that:
1. the utility model connects the operations of washing and centrifuging cells, uniformly mixing and preparing cells, filling a plurality of agents and the like in series to form a closed filling system. The system can be aseptically connected with containers such as raw materials, auxiliary materials, cleaning fluid, products and the like to automatically subpackage stem cell products. Compared with manual operation, the automatic filling machine reduces the technical difficulty of operation and improves the filling efficiency.
2. The utility model changes the prior open operation into closed operation, reduces the requirement of production environment, can be completed in a C-grade clean area environment, and meets the conditions of most of the prior cell laboratories.
3. The control of the stem cell preparation filling amount is adjusted to be peristaltic pump flow rate control from the traditional pipette visual reading, and the difference between batches and within batches is reduced.
Drawings
FIG. 1 is a schematic structural diagram of an automatic stem cell preparation filling apparatus according to the present invention;
the components in the figures are labeled as follows: 1-waste liquid bag, 2-first pipeline, 3-first pipe clamp, 4-second cell filter screen, 5-puncture needle, 6-raw material tank/bag, 7-cleaning liquid tank/bag, 8-gas communicating vessel, 9-first auxiliary tank/bag, 10-second auxiliary tank/bag, 11-product bag, 12-product distribution station, 13-third pipe clamp, 14-transfer bag, 15-sampling port, 16-first cell filter screen, 17-second pipe clamp, 18-peristaltic pump and 19-centrifugal cup.
Detailed Description
The technical solutions of the present invention will be further described below with reference to the accompanying drawings and embodiments, and the advantages and features of the present invention will become more apparent as the description proceeds. It should be understood that the examples are illustrative only and are not limiting upon the scope of the utility model.
It should be noted that the terms "left", "right", "bottom", "upper" and the like in the description and the claims of the present application indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and it is not necessarily understood that the referred devices or components must have a specific orientation, be configured or operated in a specific orientation. Furthermore, the terms first, second and third in the description and in the claims, are used for describing similar objects only and are not necessarily to be construed as a specific order or sequence.
Fig. 1 shows a specific structure of the automatic filling apparatus of the present invention, which includes a raw material tank/bag 6, a first auxiliary tank/bag 9, a second auxiliary tank/bag 10, a cleaning liquid tank/bag 7, a gas communicating vessel 8, a centrifuge cup 19, a transfer bag 14, a first cell strainer 16, a second cell strainer 4, a waste liquid bag 1, a product bag 11, and a first pipe 2.
As shown in fig. 1, the first pipe 2 connects the waste liquid bag 1, the raw material tank/bag 6, the centrifuge cup 19, the gas communicating vessel 8, the cleaning liquid tank/bag 7, the transfer bag 14, the first auxiliary tank/bag 9, the second auxiliary tank/bag 10, and the product bag 11, respectively, from left to right, from top to bottom. At the connection between the first pipe 2 and each container, a first pipe clamp 3 is provided. The first pipe clamp 3 is used to control the communication or closing of the pipes between the first pipe 2 and the respective containers.
As shown in fig. 1, in the first pipe 2 connected to the raw material tank/bag 6, a puncture needle 5 is connected to the lower end of the raw material tank/bag 6, a second cell strainer 4 is connected to the lower end of the puncture needle 5, and a first pipe clamp 3 is connected to the lower side of the second cell strainer 4. The second cell strainer 4 mainly filters the stem cell liquid flowing out of the raw material tank/bag 6 to remove larger cell aggregates therein.
In fig. 1, a peristaltic pump 18 is provided on the tubing between the upper end of the centrifuge cup 19 and the first tube clamp 3. When the peristaltic pump 18 is operated, a squeeze is created on the tubing, thereby creating a pressure on the flow of liquid in the tubing, allowing the liquid in the first tubing 2 to enter or exit the centrifuge cup 19. The material of the first pipeline 2 is preferably silicone tube, such as medical silicone tube or food grade silicone tube.
As shown in fig. 1, a first pipe clamp 3 is arranged at the connection of the gas communication device 8 and the first pipeline 2 for controlling the communication or closing of the gas communication device 8 and the first pipeline 2. The gas communicating vessel 8 is mainly used for maintaining the balance of the air pressure of the centrifugal cup 19, the first pipeline 2 and the outside, so that the cleaning liquid can smoothly enter the first pipeline 2 and further enter the centrifugal cup 19, and the stem cell suspension in the centrifugal cup is washed to remove impurities in the stem cell suspension.
In fig. 1, the lower ends of the cleaning liquid tank/bag 7, the first auxiliary tank/bag 9 and the second auxiliary tank/bag 10 are respectively connected with a puncture needle 5, and the lower end of the puncture needle 5 is connected with the first pipe clamp 3. So as to regulate the communication or closure of the cleaning solution tank/bag 7, the first auxiliary tank/bag 9 and the second auxiliary tank/bag 10 with the first pipeline 2 by controlling the opening or closing of the first pipe clamp 3.
As shown in fig. 1, the first pipe 2 is connected to a first pipe clamp 3, a first cell strainer 16, a second pipe clamp 17, and a transfer bag 14 in this order. A second pipeline connected with the first cell filter screen 16 in parallel is arranged beside the first cell filter screen 16, the lower end of the second pipeline is connected with the top end of the transfer bag 14, and the upper end of the second pipeline is connected with the first pipeline 2 through the first pipe clamp 3. A third pipe clamp 13 is arranged on the second pipeline.
The transfer bag 14 is used for adjusting the cell content of the stem cell preparation product, and a sampling port 15 is provided on the lower side wall of the transfer bag 14. The stem cell liquid sample in the transfer bag 14 is taken through the sampling port 15, and the cell content in the sample is detected. By comparing the cell content in the sample with the cell content of the final stem cell preparation product, the addition variety and the addition amount of the auxiliary materials can be controlled.
As shown in FIG. 1, product bags 11 are connected to the first conduit 2 via a product dispensing station 12, and the number of product bags 11 is determined based on the capacity of the product bags and the throughput of the same batch of stem cell feedstock fluid. In fig. 1, 5 product bags 11 are shown, each product bag 11 being connected to a product dispensing station 12 by a first tube clamp 3.
In order to better understand the technical scheme of the utility model, the following provides an operation method of stem cell preparation automatic filling equipment, which comprises the following specific steps:
1. the raw material tank/bag 6, the first auxiliary tank/bag 9, the second auxiliary tank/bag 10 and the cleaning liquid tank/bag 7 are connected into the first pipeline 2 system through the puncture needle 5, and the product bag 11 is connected with the product distribution station 12.
2. Opening the pipe clamp 3 below the raw material puncture needle 5, the pipe clamp above the centrifugal cup 19 and the peristaltic pump 18 to enable the initial raw material to flow into the centrifugal cup after being filtered by the second filter screen 4, and then closing the pipe clamp 3 below the raw material puncture needle.
3. And opening the pipe clamp at the lower side of the cleaning solution puncture needle to enable the cleaning solution to flow into the centrifugal cup 19, closing the pipe clamp at the lower side of the cleaning solution puncture needle, the pipe clamp at the upper side of the centrifugal cup 19 and the peristaltic pump 18, and then starting centrifugation.
4. After the centrifugation is finished, the pipe clamp at the inlet of the waste liquid bag, the pipe clamp on the upper side of the centrifugal cup 19 and the peristaltic pump 18 are opened, the supernatant in the centrifugal cup is discharged into the waste liquid bag 1, and then the pipe clamp at the inlet of the waste liquid bag and the peristaltic pump 18 are closed.
5. And (4) circulating the step (3) and the step (4) for multiple times, centrifuging and washing the stem cell suspension, and removing impurities in the stem cell suspension to meet the requirements of stem cell preparation products.
6. And opening the puncture needle pipe clamp and the peristaltic pump 18 below the first auxiliary material tank/bag 9 to enable the auxiliary material A to flow into the centrifugal cup 19, closing the puncture needle pipe clamp and the peristaltic pump 18 to enable the centrifugal cup 19 to rotate at a low speed, and mixing the liquid in the centrifugal cup.
7. The peristaltic pump 18, the second pipe clamp 17 above the transfer bag, the connecting pipe clamp of the transfer bag and the first pipeline and the third pipe clamp 13 are opened, so that the transfer bag 14 is communicated with the centrifuge cup 19.
8. And filtering the suspension of the auxiliary material A and the original stem cells by a first cell filter screen 16, transferring the suspension into a transfer bag, closing a peristaltic pump 18, uniformly mixing the liquid in the transfer bag, and sampling and counting through a sampling port 15.
9. Closing the second pipe clamp 17 above the transfer bag, opening the peristaltic pump 18 and the third pipe clamp 13, directly transferring the mixed liquid into the centrifuge cup through the pipe on the other side, then closing the connecting pipe clamp of the transfer bag and the first pipeline, closing the third pipe clamp 13 and the peristaltic pump 18, and disconnecting the transfer bag 14 from the centrifuge cup 19.
10. Calculating the required suspension volume (or corresponding cell suspension weight) of each product bag and the corresponding volume (or weight) of the auxiliary material B according to the counting result;
11. opening the peristaltic pump 18 and the tube clamp on the product dispensing station 12 to communicate the centrifuge cup 19 with the product bag 11, then transferring the suspension with the corresponding volume (or weight) into the 1 st product bag 11 according to the calculated volume (or weight), then closing the peristaltic pump 18, opening the tube clamp below the second auxiliary material tank/bag 10, and adding the corresponding auxiliary material B solution into the 1 st product bag 11 to meet the requirement of the medicine on the filling amount/volume.
12. After the filling of the 1 st product bag is completed, the pipe clamps between the product distribution station 12 and the first product bag are closed, then the pipe clamps between the other product bags 11 and the product distribution station 12 are sequentially opened, the subsequent product bags are sequentially filled, and meanwhile, the operation of the peristaltic pump and the communication/closing of the second auxiliary material tank/bag 10 and the first pipeline 2 are cooperatively adjusted. And when the rear product bag is filled, the product bag filled in the front is sealed in a heat sealing way until the cell solution in the centrifugal cup is filled.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all equivalent structural changes made by using the contents of the present specification, or any other related technical fields directly or indirectly, are included in the scope of the present invention.
Claims (10)
1. An automatic filling equipment of high flux stem cell preparation which characterized in that: the equipment comprises a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a centrifugal cup, a transfer bag, a first cell filter screen, a waste liquid bag, a product bag and a first pipeline;
the first pipeline is respectively connected with a raw material tank/bag, an auxiliary material tank/bag, a cleaning liquid tank/bag, a centrifugal cup, a transfer bag, a waste liquid bag and a product bag;
the first pipe clamp is arranged at the joint of the first pipeline and each container and is used for controlling the communication or closing between the first pipeline and each container;
one end of the first cell filter screen is connected with the first pipeline, and the other end of the first cell filter screen is connected with the transfer bag.
2. The automatic filling apparatus according to claim 1, wherein: the top end of the transfer bag is connected with the lower end of the first cell filter screen, and the upper end of the first cell filter screen is connected with the first pipeline;
a second pipeline connected with the first cell filter screen in parallel is arranged beside the first cell filter screen, the lower end of the second pipeline is connected with the top end of the transfer bag, and the upper end of the second pipeline is connected with the first pipeline.
3. The automatic filling apparatus of claim 2, wherein: a third pipe clamp is arranged between the first cell filter screen and the transfer bag, and a second pipe clamp is arranged between the second pipeline and the transfer bag.
4. The automatic filling apparatus according to any one of claims 1 to 3, wherein: the transfer bag is provided with a sampling port, and the sampling port is used for detecting the cell content of the cell liquid in the transfer bag.
5. The automatic filling apparatus according to any one of claims 1 to 3, wherein: the raw material tank/bag, the auxiliary material tank/bag and the cleaning liquid tank/bag are respectively connected with the first pipeline through puncture needles.
6. The automatic filling apparatus of claim 5, wherein: the automatic filling equipment further comprises a second cell filter screen, and the second cell filter screen is arranged between the puncture needle at the lower end of the raw material tank/bag and the first pipe clamp.
7. The automatic filling apparatus according to any one of claims 1 to 3, wherein: a peristaltic pump is arranged between the upper end of the centrifugal cup and the first pipe clamp, and the peristaltic pump provides power for liquid entering and exiting the centrifugal cup.
8. The automatic filling apparatus according to any one of claims 1 to 3, wherein: the number of the auxiliary material tanks/bags is at least 1, and the number of the auxiliary material tanks/bags is equal to the number of the types of auxiliary materials to be added.
9. The automatic filling apparatus according to any one of claims 1 to 3, wherein: the product bag be a plurality of, the product bag pass through product filling distribution station and connect the first pipeline.
10. The automatic filling apparatus according to any one of claims 1 to 3, wherein: the automatic filling equipment further comprises a gas communicating vessel, and the gas communicating vessel is connected with the first pipeline.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202221231764.8U CN216916398U (en) | 2022-05-23 | 2022-05-23 | Automatic filling equipment of high flux stem cell preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202221231764.8U CN216916398U (en) | 2022-05-23 | 2022-05-23 | Automatic filling equipment of high flux stem cell preparation |
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| CN216916398U true CN216916398U (en) | 2022-07-08 |
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| CN202221231764.8U Active CN216916398U (en) | 2022-05-23 | 2022-05-23 | Automatic filling equipment of high flux stem cell preparation |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115123985A (en) * | 2022-07-12 | 2022-09-30 | 深圳赛桥生物创新技术有限公司 | Pipeline emptying method and device |
| CN116062218A (en) * | 2022-12-28 | 2023-05-05 | 中博瑞康(上海)生物技术有限公司 | Full-automatic cell preparation split charging method and device thereof |
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2022
- 2022-05-23 CN CN202221231764.8U patent/CN216916398U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115123985A (en) * | 2022-07-12 | 2022-09-30 | 深圳赛桥生物创新技术有限公司 | Pipeline emptying method and device |
| CN115123985B (en) * | 2022-07-12 | 2023-08-11 | 深圳赛桥生物创新技术有限公司 | Pipeline emptying method and device |
| CN116062218A (en) * | 2022-12-28 | 2023-05-05 | 中博瑞康(上海)生物技术有限公司 | Full-automatic cell preparation split charging method and device thereof |
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