CN219596297U - Deep filtration system and antibody medicine purification device - Google Patents

Abstract

The utility model discloses a deep filtration system and an antibody medicine purification device. According to the deep filtration system with the structure, the driving piece drives the circulation of the antibody protein sample liquid, the flow guiding element guides the antibody protein sample liquid to the deep filtration piece, and the HCP is filtered and trapped through the deep filtration piece so as to reduce the concentration of the HCP in the antibody protein sample liquid, and the UV sensor detects the concentration of target protein in the antibody protein sample liquid after deep filtration, so that the deep filtration system performs subsequent collection work when the concentration of the target protein meets the requirement, and effective purified antibody protein liquid medicine is obtained. The utility model optimizes the filtering and purifying structure, and has the advantages of rapid acquisition of the required antibody protein liquid medicine and high purifying efficiency.

Description

Deep filtration system and antibody medicine purification device

Technical Field

The utility model relates to the technical field of medicine production, in particular to a deep filtration system and an antibody medicine purification device.

Background

Host Cell Proteins (HCPs) are process-related impurities expressed by host cells used to produce biopharmaceutical proteins. During purification, most of the HCP is removed, but the residual HCP amounts remain in the distributed product, such as monoclonal antibodies (mabs), antibody-drug conjugates (ADCs), therapeutic proteins, vaccines, and other protein-based biopharmaceuticals.

At present, an affinity chromatography system can be used for filtering HCP, the affinity chromatography is used for carrying out ultrafiltration process through anion exchange chromatography and cation exchange chromatography, the HCP to be filtered can be concentrated to a filtering area, the affinity chromatography system can be used for preparing an antibody sample with lower HCP content, but the whole filtering process is complex in operation, consumes more human and material resources and time cost, and has the problem of low purification efficiency of antibody protein medicines.

Disclosure of Invention

The technical problem to be solved by the utility model is that the purification efficiency of antibody protein drugs is low; the utility model aims to provide a filtering system for rapidly obtaining the antibody protein purified by the drug with low cost and high efficiency.

The present utility model provides a depth filtration system comprising:

a drive member adapted to drive the flow of an antibody protein sample fluid;

the deep layer filter piece is arranged in communication with the driving piece, and is arranged in the driving flow direction of the driving piece;

and the driving piece and the deep layer filtering piece are respectively communicated with the flow guiding element along the driving flow direction, the flow guiding element is provided with a UV sensor, the UV sensor is suitable for detecting the concentration of target protein, and the UV sensor is arranged in the downstream direction of the deep layer filtering piece.

Optionally, the deep layer filter comprises a body and a plurality of filter units, wherein the filter units are arranged in the inner cavity of the body and are arranged in a superposition manner;

the body has a medium inlet and a medium outlet in communication with an interior cavity thereof, the medium inlet and the medium outlet being in fluid connection with the flow directing element, respectively.

Optionally, the deep layer filtering piece further comprises an exhaust port, the exhaust port is formed on the deep layer filtering piece, and the exhaust port is used for communicating the inner cavity of the body with an external exhaust device.

Optionally, the depth filtration system further includes a flow cell, wherein the flow cell is used for accommodating antibody protein sample liquid subjected to depth filtration, the flow cell is arranged between the depth filtration piece and the UV sensor, and the flow inlet and outlet ends of the flow cell are respectively connected with the flow guiding element in a sealing manner.

Optionally, the depth filtration system further comprises a pH sensor, wherein the pH sensor is installed on the flow cell, and a detection end of the pH sensor extends into the flow cell;

and the conductivity sensor is arranged on the flow cell, and the detection end of the conductivity sensor extends into the flow cell.

Optionally, the depth filtration system further includes a flow path switching member, where the flow path switching member is configured with a collecting flow path, the flow path switching member is installed at an outflow end of the flow guiding element, and a first output end of the flow path switching member is fluidly connected with an input end of the collecting flow path;

and the collecting cavity is used for collecting antibody protein sample liquid subjected to deep filtration, and the collecting cavity is communicated with the output end of the collecting flow path.

Optionally, the depth filtration system further comprises a drain flow path, wherein the drain flow path is in fluid connection with the second output end of the flow path switching member.

Optionally, the depth filtration system further comprises a pressure sensor for detecting an upstream pressure value of the depth filtration member, the pressure sensor being mounted on the flow guiding element, the pressure sensor being disposed between the driving member and the depth filtration member; and/or

The sample chamber is suitable for storing antibody protein sample liquid, and the sample chamber is in fluid connection with the driving piece.

Optionally, the depth filtration system further includes a liquid inlet member, one end of the liquid inlet member is disposed in communication with the sample cavity, and the other end of the liquid inlet member is in fluid connection with the driving member.

Optionally, the deep layer filtering piece is a filtering membrane package, and the filtering membrane package is configured with filtering structure and adsorption structure.

An antibody drug purification device comprises the depth filtration system.

The technical scheme provided by the utility model has the following advantages:

1. the utility model provides a deep filtration system which comprises a driving piece, a deep filtration piece and a flow guiding element, wherein the deep filtration piece is communicated with the driving piece, and the deep filtration piece is arranged in the driving flow direction of the driving piece; the driving piece and the deep layer filtering piece are respectively communicated with the flow guiding element along the driving flow direction, the flow guiding element is provided with a UV sensor, the UV sensor is suitable for detecting the concentration of target protein, and the UV sensor is arranged in the downstream direction of the deep layer filtering piece.

According to the deep filtration system with the structure, the driving piece drives the circulation of the antibody protein sample liquid, the flow guiding element guides the antibody protein sample liquid to the deep filtration piece, and the HCP is filtered and trapped through the deep filtration piece so as to reduce the concentration of the HCP in the antibody protein sample liquid, and the UV sensor detects the concentration of target protein in the antibody protein sample liquid after deep filtration, so that the deep filtration system performs subsequent collection work when the concentration of the target protein meets the requirement, and an effective purified antibody protein liquid medicine is obtained.

2. The deep layer filter comprises a body and a plurality of filter units, wherein the filter units are arranged in an inner cavity of the body and are overlapped with each other; the body has a medium inlet and a medium outlet communicating with the inner cavity thereof, the medium inlet and the medium outlet being respectively in fluid connection with the flow guiding element.

According to the deep filtration system with the structure, the antibody protein sample liquid is led into the inner cavity of the body through the medium inlet, HCPs are filtered by utilizing the filtering units which are overlapped and arranged in the inner cavity of the body, so that the concentration of the HCPs in the antibody protein sample liquid is reduced, and the filtered antibody protein sample liquid is transmitted to the detection assembly through the medium outlet through the flow guide element, so that the concentration of target proteins in the antibody protein liquid is detected, and the purification efficiency of the system is improved.

3. The deep filtration system provided by the utility model further comprises a flow cell, wherein the flow cell is used for accommodating antibody protein sample liquid subjected to deep filtration, the flow cell is arranged between the deep filtration piece and the UV sensor, and the flow inlet and outlet ends of the flow cell are respectively connected with the flow guiding element in a sealing way.

According to the deep filtration system with the structure, the configured flow cell is used for accommodating the antibody protein sample liquid subjected to deep filtration, so that the antibody protein sample liquid discharged from the flow cell is promoted to flow stably, the reliable detection environment of the UV sensor for detecting the target protein is ensured, and the detection precision is improved.

4. The utility model provides a deep filtration system, which further comprises a flow path switching piece and a collecting cavity, wherein the flow path switching piece is provided with a collecting flow path, the flow path switching piece is arranged at the outflow end of a flow guiding element, and the first output end of the flow path switching piece is in fluid connection with the input end of the collecting flow path; the collecting cavity is used for collecting antibody protein sample liquid through deep filtration, and the collecting cavity is communicated with the output end of the collecting flow path.

In the deep filtration system with the structure, the first output end is adjusted through the flow path switching piece, so that the flow guiding element is communicated with or sealed with the collecting flow path; when the UV sensor detects that the concentration of target protein in the antibody protein sample liquid after deep filtration meets the required concentration, the collection cavity is opened to collect the antibody protein sample liquid with the required concentration by opening the first output end of the flow path switching piece, so that the collection work of the deep filtration system is completed.

5. The utility model provides an antibody medicine purification device, which comprises a deep filtration system. The antibody medicine purifying device drives the drainage antibody protein sample liquid through a driving piece configured by a depth filtration system, the depth filtration piece filters and intercepts HCP in the circulating liquid, and the UV sensor detects the concentration of target protein in the antibody protein sample liquid after depth filtration, so that the antibody protein sample liquid meeting the requirements is obtained at the output end of the flow guiding element.

Drawings

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present utility model, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram illustrating the operation of a depth filtration system provided in an embodiment of the present utility model;

FIG. 2 is a schematic view of a depth filter in a depth filtration system according to an embodiment of the present utility model;

FIG. 3 is a schematic view showing a structure of a filter unit in a depth filtration system according to an embodiment of the present utility model;

FIG. 4 is a graph of the monitoring data provided in example 3 of the present utility model;

fig. 5 is a graph of monitoring data for UV280 provided in example 3 of the present utility model.

Reference numerals illustrate:

1-a driving member; 2-sample chamber;

3-a flow guiding element;

4-deep layer filter; 41-medium inlet; 42-medium outlet; 43-exhaust port; 44-a filtration unit;

a 51-UV sensor; 52-a pressure sensor; 53-pH sensor; 54-conductivity sensor;

6-a flow cell;

7-a flow path switching member; 71-a collection flow path; 72-a discharge flow path;

8-a collection chamber; 9-liquid inlet piece.

Detailed Description

The following description of the embodiments of the present utility model will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the utility model are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

In the description of the present utility model, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present utility model and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present utility model, it should be noted that, unless explicitly specified and limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

In addition, the technical features of the different embodiments of the present utility model described below may be combined with each other as long as they do not collide with each other.

Example 1

The embodiment provides a deep filtration system, as shown in fig. 1 and 2, which comprises a driving piece 1, a deep filtration piece 4, a flow guiding element 3 and a detection component, wherein the deep filtration piece 4 is communicated with the driving piece 1, and the deep filtration piece 4 is arranged in the driving flow direction of the driving piece 1; the driving part 1 and the deep filter part 4 are respectively communicated with the flow guiding element 3 along the driving flow direction.

Wherein the detection assembly comprises a UV sensor 51 and a pressure sensor 52, the UV sensor 51 is suitable for detecting the concentration of target protein, the UV sensor 51 is arranged on the flow guiding element 3, the UV sensor 51 is arranged in the downstream direction of the deep layer filtering piece 4, and one or more UV sensors 51 are arranged; the pressure sensor 52 is used for detecting the upstream pressure value of the deep-layer filter element 4, the pressure sensor 52 is mounted on the flow guiding element 3, and the pressure sensor 52 is arranged between the driving element 1 and the deep-layer filter element 4.

As shown in fig. 2 and 3, the deep-layer filter 4 comprises a body and a plurality of filter units 44, wherein the filter units 44 are arranged in the inner cavity of the body, and the filter units 44 are arranged in a superposition manner; the body has a medium inlet 41 and a medium outlet 42 communicating with its lumen, the medium inlet 41 and the medium outlet 42 being in fluid connection with the flow guiding element 3, respectively. The antibody protein sample liquid is led into the inner cavity of the body through the medium inlet 41, HCP is filtered by utilizing the filtering units 44 which are overlapped and arranged in the inner cavity of the body, so that the concentration of HCP in the antibody protein sample liquid is reduced, and the filtered antibody protein sample liquid is transmitted to the detection assembly through the medium outlet 42 through the flow guiding element 3, so that the concentration of target protein in the antibody protein liquid is detected, and the purification efficiency of the system is improved.

As shown in fig. 2, the deep-layer filter 4 further includes an exhaust port 43, the exhaust port 43 is formed on the deep-layer filter 4, and the exhaust port 43 is used for communicating the inner cavity of the body with an external exhaust device. Before the antibody protein sample liquid is circulated, the air in the inner cavity of the diversion element 3 and the body is discharged through the air outlet 43 by an ultrapure water rinsing system, so that the circulation of the medium is quickened, and the medium circulation time is shortened; the vent 43 is closed when the antibody protein sample solution is circulated.

In some embodiments, the filtration unit is a deep filtration membrane, and a plurality of deep filtration membranes are stacked and arranged to obtain a good effect of filtering and trapping HCP impurities.

In some embodiments, the deep-layer filter 4 is a layered structure composed of cellulose, diatomaceous earth and/or perlite, and a wet strength agent to filter HCP impurities.

In this embodiment, the flow guiding element 3 is provided as a plurality of flow guiding pipes, and the flow guiding pipes are used to match with the antibody protein sample liquid driven by the driving element 1 to pass through the deep layer filtering element 4 and then to be transferred to the flow path switching element 7.

The depth filtration system provided in this embodiment further includes a flow cell 6, as shown in fig. 1, where the flow cell 6 is used for accommodating the antibody protein sample liquid subjected to depth filtration, the flow cell 6 is disposed between the depth filter 4 and the UV sensor 51, and the inlet and outlet ends of the flow cell 6 are respectively connected with the flow guiding element 3 in a sealing manner. The prepared flow cell 6 contains the antibody protein sample liquid subjected to deep filtration, so that the antibody protein sample liquid discharged out of the flow cell 6 is promoted to flow stably, the reliable detection environment for detecting the target protein by the UV sensor 51 is ensured, and the detection precision is improved.

The detection assembly further comprises a pH sensor 53 and a conductivity sensor 54, wherein the pH sensor 53 and the conductivity sensor 54 are arranged on the flow cell 6, and the detection end of the conductivity sensor 54 and the detection end of the pH sensor 53 respectively extend into the flow cell 6 so as to detect and acquire corresponding conductivity values and pH values.

The depth filtration system provided in this embodiment further includes a flow path switching member 7 and a collection chamber 8, as shown in fig. 1, the flow path switching member 7 is configured with a collection flow path 71, the flow path switching member 7 is installed at an outflow end of the flow guiding element 3, and a first output end of the flow path switching member 7 is in fluid connection with an input end of the collection flow path 71; the collection chamber 8 is used for collecting antibody protein sample liquid through deep filtration, and the collection chamber 8 is communicated with the output end of the collection flow path 71. The first output end is adjusted by the flow path switching piece 7, so that the flow guiding element 3 and the collecting flow path 71 are communicated or closed; when the UV sensor 51 detects that the concentration of the target protein in the antibody protein sample liquid after depth filtration meets the required concentration, the collection cavity 8 is enabled to collect the antibody protein sample liquid with the required concentration by opening the first output end of the flow path switching piece 7, so that the collection work of the depth filtration system is completed.

The depth filtration system further comprises a drain flow path 72, the drain flow path 72 being in fluid connection with the second output end of the flow path switching element 7. When the switching of the flow path switching member 7 opens the second output, the flow medium in the flow guiding element 3 is guided out of the system through the discharge flow path 72.

The depth filtration system provided in this embodiment further includes a controller, where the controller is configured to receive detection data of the UV sensor 51, the pressure sensor 52, the pH sensor 53, and the conductivity sensor 54, and the controller may be electrically connected to the flow path switching member 7, so as to control switching of the flow path switching member 7, so as to perform on-off operation on the first output end and the second output end respectively.

In this embodiment, the controller configures a range threshold of the concentration of the target protein, and when the target protein satisfies the required concentration range, the controller adjusts the flow path switching member 7 to open the first output end and close the second output end, thereby performing the collection work of the purified antibody protein liquid medicine.

In the present embodiment, the flow path switching member 7 is configured as an electronic three-way valve having one inlet port fluidly connected to the output end of the flow guiding element 3 and two outlet ports configured as a first output end and a second output end of the flow path switching member 7, respectively.

The deep filtration system provided in this embodiment further comprises a sample chamber 2 and a liquid inlet member 9, wherein the sample chamber 2 is adapted to store an antibody protein sample liquid, and the sample chamber 2 is in fluid connection with the driving member 1. One end of the liquid inlet piece 9 is communicated with the sample cavity 2, and the other end of the liquid inlet piece 9 is in fluid connection with the driving piece 1. Under the driving action of the driving piece 1, the antibody protein sample liquid in the sample cavity 2 is guided to the deep layer filtering piece 4 through the guiding element 3.

According to the deep filtration system provided by the embodiment, the driving piece 1 drives the circulation of the antibody protein sample liquid, the flow guiding element 3 guides the antibody protein sample liquid to the deep filtration piece 4, the deep filtration piece 4 filters and intercepts HCP so as to reduce the concentration of HCP in the antibody protein sample liquid, the UV sensor 51 detects the concentration of target protein in the antibody protein sample liquid after deep filtration, and the deep filtration system performs subsequent collection work when the concentration of target protein meets the requirement so as to obtain effective purified antibody protein liquid.

Example 2

An antibody drug purification apparatus comprising the depth filtration system of example 1. The antibody medicine purifying device drives the drainage antibody protein sample liquid through a driving piece 1 configured by a depth filtration system, the depth filtration piece 4 filters and intercepts HCP in the circulating liquid, and the UV sensor 51 detects the target protein concentration in the antibody protein sample liquid after depth filtration, so that the antibody protein sample liquid meeting the requirements is obtained at the output end of the flow guiding element 3.

Example 3

The embodiment provides a method for purifying monoclonal antibodies, which is applied to the depth filtration system of embodiment 1 and the antibody drug purification device of embodiment 2, and can be adapted to the practical application filtration environment;

configuring a sample cavity 2 as a column position valve of chromatographic equipment, constructing a deep filtration system for experiments, and obtaining monitoring data of impurity penetration points; the deep layer filtering piece 4 is arranged as a deep layer filtering film bag;

the purification method comprises the following steps:

(1) The flow guiding element 3 is connected with the medium inlet 41 and the medium outlet 42 of the deep layer filter 4 by using connectors, the filtering capacity of the deep layer filter 4 is 1500g/m < 2 >, and the deep layer filter 4 is connected on a column position valve of chromatographic equipment in a sealing way to finish column position reconstruction;

(2) After the system is rinsed and exhausted by ultrapure water, 23ml of balance buffer solution is used, the balance buffer solution is 50mmo L/L and pH5.5 of acetic acid-sodium acetate, a filter unit in the deep filter element 4 is rinsed, a conductivity value detection curve is observed, and after the conductivity value rises steadily, rinsing is stopped;

(3) Using a sample pump to collect the affinity chromatography collection liquid of the trastuzumab, wherein the volume is 305.45m L, the concentration of the antibody protein is 23.60g/L, and the residue of host protein is more than 15000ppm; loading the sample into a deep filtration system, and connecting the system with peripheral equipment to generate visual dynamic monitoring data shown in the figure 4, wherein the monitoring data comprises a UV280/UV254 absorption value, a conductivity value and a pressure value; when the UV280 absorption value is observed to rise to 50mAU/mm, the system starts to collect filtrate;

(4) By detecting the curve change of the absorption values of UV280 and UV254, the impurity penetration point range can be confirmed: in the UV280 monitoring data graph shown in fig. 5, the UV280 absorption value between the point a and the point B rapidly increases by 15mAU;

table 1 shows the monitoring data of points A and B

	UV280(mAU)	Abscissa volume point (ml)	Sample application volume (ml)
				Point A	2665	1398	166
Point B	2680	1405	173

The A point corresponds to 166ml of sample volume, the UV280 absorption value is 2665mAU, the abscissa is 1398ml, the B point corresponds to 173ml of sample volume, the UV280 absorption value is 2680mAU, and the abscissa is 1405ml, so that the interval is judged to contain impurity penetration points, and filtrate collection is stopped; when the concentration of antibody protein of the sample is higher, the deep filter membrane is easy to overload, an impurity penetrating interval can appear, and the filtrate collected later when the impurity penetrating interval appears does not meet the requirement of target protein;

(5) The sample was changed to an equilibration buffer, the UV280 absorbance was observed continuously, and after it was reduced to 50mAU/mm, the sample was collected to give a purified sample, which was 424.41ml in volume and 16.392g/L antibody protein concentration.

The results showed that the purified samples of this example were within the quality standard range for HCP < 100ppm and DNA < 100ppb before no significant increase in UV detection. The antibody protein recovery of the purification method of this example was greater than 90%.

In the embodiment, for the on-line sample with higher antibody protein concentration and host protein residue of more than 15000ppm, the deep filter membrane is easy to overload, and the embodiment can obtain an on-line impurity penetration curve graph by detecting dynamic detection data with UV280 of more than 50 mAU/mm; judging an impurity penetration zone through a graph: in the range of 5-10ml loading, the UV rises beyond 15mAU, impurity penetration intervals occur, resulting in the filtrate subsequently collected at the occurrence of the impurity penetration intervals not meeting the target protein requirement.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the utility model.

Claims (10)

1. A depth filtration system, comprising:

a driving member (1), the driving member (1) being adapted to drive the circulation of an antibody protein sample fluid;

the deep layer filter (4) is arranged in communication with the driving piece (1), and the deep layer filter (4) is arranged in the driving flow direction of the driving piece (1);

and the driving piece (1) and the deep layer filtering piece (4) are respectively communicated with the flow guiding element (3) along the driving flow direction, a UV sensor (51) is arranged on the flow guiding element (3), the UV sensor (51) is suitable for detecting the concentration of target protein, and the UV sensor (51) is arranged in the downstream direction of the deep layer filtering piece (4).

2. The depth filtration system of claim 1, wherein the depth filter (4) comprises a body and a plurality of filter units (44), the filter units (44) being mounted in the body lumen, the filter units (44) being arranged in a stacked arrangement with respect to each other;

the body has a medium inlet (41) and a medium outlet (42) communicating with its lumen, the medium inlet (41) and the medium outlet (42) being in fluid connection with the flow guiding element (3), respectively.

3. The depth filtration system of claim 2, wherein the depth filter (4) further comprises an exhaust port (43), the exhaust port (43) being formed in the depth filter (4), the exhaust port (43) being configured to communicate the body lumen with an external exhaust device.

4. The depth filtration system of claim 1, further comprising a flow cell (6), the flow cell (6) being configured to receive a depth-filtered antibody protein sample fluid, the flow cell (6) being disposed between the depth filter (4) and the UV sensor (51), the flow-in and flow-out ends of the flow cell (6) being respectively in sealing connection with the flow-guiding element (3).

5. The depth filtration system of claim 4, further comprising a pH sensor (53), the pH sensor (53) being mounted on the flow cell (6), a detection end of the pH sensor (53) extending into the flow cell (6);

-a conductivity sensor (54), the conductivity sensor (54) being mounted on the flow cell (6), a detection end of the conductivity sensor (54) extending into the flow cell (6).

6. The depth filtration system of claim 1, further comprising a flow path switch (7), the flow path switch (7) being configured with a collection flow path (71), the flow path switch (7) being mounted at an outflow end of the flow guiding element (3), a first output end of the flow path switch (7) being in fluid connection with an input end of the collection flow path (71);

and a collection chamber (8), wherein the collection chamber (8) is used for collecting antibody protein sample liquid through depth filtration, and the collection chamber (8) is communicated with the output end of the collection flow path (71).

7. The depth filtration system of claim 6, further comprising a drain flow path (72), the drain flow path (72) being in fluid connection with the second output end of the flow path switching member (7).

8. The depth filtration system according to any one of claims 1-7, further comprising a pressure sensor (52), the pressure sensor (52) being adapted to detect an upstream pressure value of the depth filter (4), the pressure sensor (52) being mounted on the flow guiding element (3), the pressure sensor (52) being arranged between the driver (1) and the depth filter (4); and/or

The device further comprises a sample cavity (2), wherein the sample cavity (2) is suitable for storing antibody protein sample liquid, and the sample cavity (2) is in fluid connection with the driving piece (1).

9. The depth filtration system of claim 8, further comprising a liquid inlet member (9), wherein one end of the liquid inlet member (9) is in communication with the sample chamber (2), and wherein the other end of the liquid inlet member (9) is in fluid connection with the driver member (1).

10. An antibody drug purification apparatus comprising a depth filtration system according to any one of claims 1-9.