An ultrafiltration system with real-time protein concentration regulation function

Abstract

This invention discloses an ultrafiltration system with real-time protein concentration control, belonging to the field of biopharmaceutical technology. The system includes a replenishment tank, a recirculation tank, an ultrafiltration unit, and a controller. The recirculation tank is connected to the replenishment tank via a replenishment pipe, which is equipped with a replenishment pump and a valve, with the valve located between the replenishment pump and the recirculation tank. A protein concentration detection component A is located at the bottom of the recirculation tank. The ultrafiltration unit is connected to the recirculation tank via a delivery pipe and a return pipe. A circulation pump is installed on the delivery pipe, and a back pressure component and a protein concentration detection component B are installed on the return pipe. This system can improve the consistency of protein concentration in the recirculation tank during constant-volume dialysis, reduce batch-to-batch differences in protein concentration, and thus improve the uniformity of product quality. It can also prevent concentration polarization caused by excessively high protein concentration from affecting protein stability.

Description

Technical Field

[0001] This utility model relates to an ultrafiltration system with real-time protein concentration regulation function, belonging to the field of biopharmaceutical technology. Background Technology

[0002] Ultrafiltration machines are essential equipment for the final formulation production of protein drugs. They can retain the target protein drug on the upper side of the ultrafiltration membrane and then return it to the recirculation container, thereby realizing the liquid exchange dialysis and protein concentration of the protein solution.

[0003] For example, Chinese patent document CN216594765U discloses an online ultrafiltration system for detecting target protein concentration and flow rate. The system includes a feed reflux device, an ultrafiltration unit, an ultrafiltrate collection device, a protein concentration detection device, a flow rate detection device, and a pressure detection device. These devices monitor protein concentration, protein flow rate, and pressure in the pipeline during the ultrafiltration process. This ultrafiltration system avoids repeated offline sampling, reduces operational complexity and the risk of product contamination, and allows for better monitoring of the protein solution's concentration or dialysis performance within the ultrafiltration system, preventing potential process deviations.

[0004] However, during liquid exchange dialysis, the product quality may be inconsistent due to differences in protein concentration between different batches of feed solution. In addition, during the concentration process, excessively high protein concentration may cause concentration polarization of the protein on the ultrafiltration membrane, thereby affecting the stability of the protein. Utility Model Content

[0005] To solve the above-mentioned technical problems, this utility model provides an ultrafiltration system with real-time protein concentration control function.

[0006] This utility model is achieved through the following technical solution:

[0007] An ultrafiltration system with real-time protein concentration control includes a replenishment tank, a recirculation tank, an ultrafiltration unit, and a controller. The recirculation tank is connected to the replenishment tank via a replenishment pipe. A replenishment pump and a valve are installed on the replenishment pipe, with the valve located between the replenishment pump and the recirculation tank. A protein concentration detection component A is installed at the bottom of the recirculation tank. The ultrafiltration unit is connected to the recirculation tank via a delivery pipe and a return pipe. A circulation pump is installed on the delivery pipe, and a back pressure component and a protein concentration detection component B are installed on the return pipe. The controller is electrically connected to the replenishment pump, the valve, the protein concentration detection component A, the circulation pump, the protein concentration detection component B, and the back pressure component.

[0008] The top of the recirculation tank is connected to the bottom of the replenishment tank via a replenishment pipe.

[0009] The valve is an electric ball valve.

[0010] Both protein concentration detection component A and protein concentration detection component B are online refractometers.

[0011] The end of the liquid delivery pipe furthest from the ultrafiltration machine is connected to the bottom of the recirculation tank.

[0012] The end of the return pipe furthest from the ultrafiltration unit is connected to the top of the recirculation tank.

[0013] The back pressure component is an electric back pressure valve.

[0014] The beneficial effects of this invention are as follows: During the dialysis process, the protein concentration of the feed solution in the recirculation tank is detected in real time by the protein concentration detection component A, and the relevant protein concentration information is transmitted to the controller. The controller adjusts the valve opening according to the protein concentration of the feed solution to control the flow rate of the dialysate into the recirculation tank, thereby improving the consistency of protein concentration of the feed solution in the recirculation tank during constant volume dialysis, reducing the difference in protein concentration between batches, and thus improving the uniformity of product production quality.

[0015] During the protein concentration process, the protein concentration of the feed solution in the return pipe is monitored in real time by the protein concentration detection component B, and the relevant protein concentration information is transmitted to the controller. The controller determines whether the protein concentration of the feed solution after ultrafiltration concentration has reached the preset protein concentration: if the protein concentration of the feed solution is significantly higher than the preset protein concentration of the controller, the pump speed and pressure of the circulation pump are increased to increase the flow rate of the feed solution delivered to the ultrafiltration machine, or the circulation pump is turned off to terminate the concentration, so as to avoid concentration polarization due to excessively high protein concentration affecting the stability of the protein; if the protein concentration of the feed solution has not reached the preset protein concentration of the controller, the concentration continues. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of this utility model.

[0017] In the diagram: 1-Replenishment tank, 2-Replenishment pipe, 3-Replenishment pump, 4-Valve, 5-Recirculation tank, 6-Protein concentration detection component A, 7-Delivery pipe, 8-Circulation pump, 9-Ultrafiltration unit, 10-Return pipe, 11-Protein concentration detection component B, 12-Back pressure component. Detailed Implementation

[0018] The technical solution of this utility model is further described below, but the scope of protection is not limited to what is described.

[0019] like Figure 1As shown, the ultrafiltration system with real-time protein concentration control function of this utility model includes a replenishment tank 1, a recirculation tank 5, an ultrafiltration unit 9, and a controller. The recirculation tank 5 is connected to the replenishment tank 1 through a replenishment pipe 2. A replenishment pump 3 and a valve 4 are installed on the replenishment pipe 2, and the valve 4 is located between the replenishment pump 3 and the recirculation tank 5. A protein concentration detection component A6 is provided at the bottom of the recirculation tank 5. The ultrafiltration unit 9 is connected to the recirculation tank 5 through a delivery pipe 7 and a return pipe 10. A circulation pump 8 is provided on the delivery pipe 7, and a back pressure component 12 and a protein concentration detection component B11 are provided on the return pipe 10. The controller is electrically connected to the replenishment pump 3, the valve 4, the protein concentration detection component A6, the circulation pump 8, the protein concentration detection component B11, and the back pressure component 12.

[0020] During the ultrafiltration dialysis replacement phase, the replenishment pump 3 and circulation pump 8 are activated. The dialysate in the replenishment tank 1 flows into the recirculation tank 5 through the replenishment pipe 2. The feed solution in the recirculation tank 5 flows into the ultrafiltration machine 9 through the delivery pipe 7. The feed solution in the ultrafiltration machine 9 that has not permeated through the ultrafiltration membrane returns to the recirculation tank 5 through the return pipe 10. During the dialysis replacement process, the protein concentration of the feed solution in the recirculation tank 5 is monitored in real time by the protein concentration detection component A6, and the relevant protein concentration information is transmitted to the controller. The controller adjusts the opening of valve 4 according to the protein concentration of the feed solution to control the flow rate of dialysate entering the recirculation tank 5. This improves the consistency of protein concentration in the feed solution in the recirculation tank 5 during constant-volume dialysis, reduces the difference in protein concentration between batches, and thus improves the uniformity of product production quality.

[0021] During the ultrafiltration concentration stage, the replenishment pump 3 is turned off, and the circulation pump 8 is started. The feed solution in the recirculation tank 5 flows into the ultrafiltration unit 9 through the delivery pipe 7. The feed solution in the ultrafiltration unit 9 that has not permeated through the ultrafiltration membrane returns to the recirculation tank 5 through the return pipe 10. This cycle is repeated to achieve protein concentration. During the protein concentration process, the protein concentration of the feed solution in the return pipe 10 is monitored in real time by the protein concentration detection component B11, and the relevant protein concentration information is transmitted to the controller. The controller determines whether the protein concentration of the feed solution after ultrafiltration concentration has reached the preset protein concentration: if the protein concentration of the feed solution is significantly higher than the preset protein concentration, the pump speed and pressure of the circulation pump 8 are increased to increase the flow rate of the feed solution delivered to the ultrafiltration unit 9, or the circulation pump 8 is turned off to terminate the concentration, so as to avoid concentration polarization due to excessively high protein concentration, which would affect the stability of the protein; if the protein concentration of the feed solution has not reached the preset protein concentration, the concentration continues.

[0022] The ultrafiltration system provided by this invention can realize online detection of protein concentration in the feed solution, avoiding repeated manual sampling and testing, and reducing the risk of feed solution contamination.

[0023] The top of the recirculation tank 5 is connected to the bottom of the replenishment tank 1 via the replenishment pipe 2.

[0024] Valve 4 is an electric ball valve.

[0025] Both protein concentration detection components A6 and B11 are online refractometers. The brand of the online refractometer is K-Patents, and the model is PR-43-S.

[0026] The end of the liquid delivery pipe 7 that is away from the ultrafiltration machine 9 is connected to the bottom of the recirculation tank 5.

[0027] The end of the return pipe 10 away from the ultrafiltration unit 9 is connected to the top of the recirculation tank 5.

[0028] The back pressure assembly 12 is an electric back pressure valve.

Claims

1. An ultrafiltration system with real-time protein concentration control function, characterized in that: The system includes a replenishment tank (1), a recirculation tank (5), an ultrafiltration unit (9), and a controller. The recirculation tank (5) is connected to the replenishment tank (1) via a replenishment pipe (2). A replenishment pump (3) and a valve (4) are installed on the replenishment pipe (2), and the valve (4) is located between the replenishment pump (3) and the recirculation tank (5). A protein concentration detection component A (6) is provided at the bottom of the recirculation tank (5). The ultrafiltration unit (9) is connected to the recirculation tank (5) via a delivery pipe (7) and a return pipe (10). A circulation pump (8) is provided on the delivery pipe (7), and a back pressure component (12) and a protein concentration detection component B (11) are provided on the return pipe (10). The controller is electrically connected to the replenishment pump (3), the valve (4), the protein concentration detection component A (6), the circulation pump (8), the protein concentration detection component B (11), and the back pressure component (12).

2. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: The top of the recirculation tank (5) is connected to the bottom of the replenishment tank (1) via a replenishment pipe (2).

3. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: The valve (4) is an electric ball valve.

4. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: Both protein concentration detection component A (6) and protein concentration detection component B (11) are online refractometers.

5. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: The end of the liquid delivery pipe (7) away from the ultrafiltration machine (9) is connected to the bottom of the recirculation tank (5).

6. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: The end of the return pipe (10) away from the ultrafiltration machine (9) is connected to the top of the recirculation tank (5).

7. The ultrafiltration system with real-time protein concentration control function as described in claim 1, characterized in that: The back pressure assembly (12) is an electric back pressure valve.

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