High-throughput filter membrane screening plate

Abstract

The utility model discloses a high-throughput filter membrane screening plate, relates to a biological medicine research and development device, and is used for testing the filtering effects of different filter membranes on biological macromolecular medicines in a high-throughput manner. The device comprises an upper-layer plate, a lower-layer plate and a cover plate, a filter membrane is clamped between the upper-layer plate and the lower-layer plate, the filtering effect of different filter membranes on biological macromolecular drugs can be tested in a multi-channel and high-throughput mode, testing and analysis can be conducted only through a trace amount of macromolecular drug samples, and therefore the filter membrane screening efficiency is greatly improved, and raw materials are saved.

Description

Technical Field

[0001] This utility model relates to a biomedical research and development device, and more specifically, to a high-throughput filter membrane screening plate. Background Technology

[0002] Biological macromolecules, as representative biological drugs, are a class of biological macromolecules produced using modern biotechnology for disease diagnosis, treatment, and prevention. These include monoclonal antibodies (mAbs), recombinant proteins, peptides, enzymes, and cytokines produced through genetic engineering. These drugs are characterized by strong targeting, high specificity, low toxicity, and high sensitivity, representing the forefront of current biomedical research, with rapid development and broad application prospects. Among them, mAbs dominate the biopharmaceutical market. Since the U.S. Food and Drug Administration approved the first mAb for the prevention of acute transplant rejection, OKT3, in 1986, more than 100 antibody drugs have been approved, with global sales exceeding $200 billion, accounting for more than 50% of the global biopharmaceutical market. Due to the remarkable efficacy of these drugs in treating various major diseases such as malignant tumors, immune system diseases, metabolic diseases, genetic diseases, and infectious diseases, a research boom has swept the globe, with numerous research institutions both domestically and internationally conducting research and development on innovative or generic biological macromolecules.

[0003] The laboratory research and development phase of biopharmaceuticals includes drug screening, manufacturing process development, quality studies, and pharmacological and toxicological studies. The manufacturing process of biopharmaceuticals can be divided into three stages: fermentation (upstream process), purification (downstream process), and formulation. Membrane technologies, including depth filtration membranes, membrane chromatography media and equipment, virus filtration membranes, and ultrafiltration / percolation membranes for protein concentration and buffer replacement, have important applications in different stages of the downstream separation and purification process of biopharmaceuticals, including clarification, capture, purification and refining, and pre-formulation units.

[0004] In the development of membrane separation and purification processes for biopharmaceutical drugs, selecting a separation membrane with suitable pore size, material, and surface physicochemical properties is crucial. Currently, there are numerous brands and specifications of membrane materials available on the market. Providing a high-throughput screening device for membrane materials could significantly improve the development efficiency of membrane separation and purification processes for biopharmaceutical drugs. Summary of the Invention

[0005] This invention provides a high-throughput filter membrane screening plate for high-throughput testing of the filtration effect of different filter membranes on biopharmaceutical drugs.

[0006] The technical solution of this utility model is:

[0007] A high-throughput filter membrane screening plate, such as Figure 1 , Figure 2 As shown, it includes an upper plate 1, a lower plate 2, and a cover plate 10. A filter membrane 3 can be sandwiched between the upper plate 1 and the lower plate 2.

[0008] The upper plate 1 is a thin plastic sheet with through holes, made of polystyrene, polypropylene, or polyethylene, with 1 to 100 through holes in the middle, the diameter of which is between 5 mm and 15 mm (inclusive). The lower outer edge of the holes has annular protrusions 4, made of an elastic material such as silicone, rubber, or plastic, with a height between 1.5 mm and 3 mm (inclusive) and a width between 0.5 mm and 2 mm (inclusive).

[0009] The lower plate 2 is a porous, bottomed plastic sheet made of polystyrene, polypropylene, or polyethylene. The inner diameter, number, and position of the holes correspond to the through holes in the upper plate 1. The upper edge of the holes has an outwardly expanding groove 5. The inner diameter of the outwardly expanding groove 5 is the same as the outer diameter of the annular protrusion 4, and the height of the outwardly expanding groove 5 is 0.5 mm to 1.5 mm lower (inclusive) than the height of the annular protrusion 4.

[0010] The upper panel 1 and the lower panel 2 have fastening devices 6 on their sides. After the upper panel 1 and the lower panel 2 are tightly attached, they can be fixed by fastening devices 6.

[0011] The filter membrane 3 is sandwiched between the upper plate 1 and the lower plate 2. The material can be a thin film filter membrane of various pore sizes or molecular weight cutoffs, such as cellulose membrane, regenerated cellulose membrane, nylon membrane, polyethylene membrane, etc.

[0012] The method of using this utility model is as follows: separate the upper plate 1 and the lower plate 2, cut one or more filter membranes to be tested into circular pieces that match the inner diameter of the outer expansion groove 5, place them in the outer expansion groove 5 of the lower plate 2, then carefully place the upper plate 1 on top of the lower plate 2 so that the holes of the two plates correspond, fasten the buckle device 6 and lock it, place the assembled screening plate on the fully automatic liquid workstation (or automatic liquid transfer system), add the solution containing macromolecular biopharmaceuticals to each hole, then cover it with the cover plate 10, place it on a centrifuge for centrifugation, after centrifugation, open the buckle device 6, analyze the solution in each hole of the lower plate 2, and evaluate the filtration effect of the filter membrane to be tested.

[0013] The beneficial effects of this invention are that it enables multi-channel, high-throughput testing of the filtration effects of different filter membranes on biopharmaceutical drugs, and only requires a small amount of macromolecular drug sample for testing and analysis, thereby greatly improving the efficiency of filter membrane screening and saving raw materials. Attached Figure Description

[0014] Figure 1 A longitudinal sectional view of a high-throughput filter membrane screening plate before assembly.

[0015] Figure 2A longitudinal cross-sectional view of a high-throughput filter membrane screening plate after assembly.

[0016] Reference numerals: 1-Upper plate, 2-Lower plate, 3-Filter membrane, 4-Annular hole protrusion, 5-Outer expansion groove, 6-Snap fastener, 10-Cover plate. Detailed Implementation

[0017] Example 1: Structure of a high-throughput filter membrane screening plate

[0018] A high-throughput filter membrane screening plate, such as Figure 1 , Figure 2 As shown, it includes an upper plate 1, a lower plate 2, and a cover plate 10. A filter membrane 3 can be sandwiched between the upper plate 1 and the lower plate 2.

[0019] The upper plate 1 is a thin plastic sheet with through holes, made of polystyrene, with 24 through holes in the middle, each hole having a diameter of 10 mm. The lower outer edge of the holes has an annular protrusion 4, made of elastic silicone, with a height of 2 mm and a ring width of 1.5 mm.

[0020] The lower plate 2 is a porous, bottomed plastic sheet made of polystyrene, polypropylene, or polyethylene. The inner diameter, number, and position of the holes correspond to the through holes in the upper plate 1. The upper edge of the holes has an outer expansion groove 5. The inner diameter of the outer expansion groove 5 is the same as the outer diameter of the annular protrusion 4, and the height of the outer expansion groove 5 is 1 mm lower than the height of the annular protrusion 4.

[0021] The upper panel 1 and the lower panel 2 have fastening devices 6 on their sides. After the upper panel 1 and the lower panel 2 are tightly attached, they can be fixed by fastening devices 6.

[0022] The filter membrane 3 is sandwiched between the upper plate 1 and the lower plate 2. The material can be a thin film filter membrane of various pore sizes or molecular weight cutoffs, such as cellulose membrane, regenerated cellulose membrane, nylon membrane, polyethylene membrane, etc.

[0023] Example 2: A method for using a high-throughput filter membrane screening plate

[0024] The method of using this utility model is as follows:

[0025] Separate the upper plate 1 and the lower plate 2. Cut one or more filter membranes to be tested into circular pieces that match the inner diameter of the outer expansion groove 5. Place them in the outer expansion groove 5 of the lower plate 2. Then carefully place the upper plate 1 on top of the lower plate 2 so that the holes of the two plates correspond. Fasten the buckle device 6 and lock it.

[0026] Place the assembled screening plate onto a fully automated liquid workstation (or automated pipetting system), add the solution containing macromolecular biopharmaceuticals to each well, then cover with the cover plate 10 and place on a centrifuge for centrifugation.

[0027] After centrifugation, open the latch device 6 and analyze the solution in each hole of the lower plate 2 to evaluate the filtration effect of the filter membrane under test.

Claims

1. A high-throughput filter membrane screening plate, characterized in that, It consists of an upper plate (1), a lower plate (2) and a cover plate (10). The upper plate (1) is a thin plate with through holes, with 1 to 100 through holes in the middle. The lower outer edge of the through holes has an annular hole protrusion (4), and the material of the annular hole protrusion (4) is elastic. The lower plate (2) is a porous thin plate with a bottom. The inner diameter, number and position of the holes correspond to the through holes of the upper plate (1). The upper edge of the holes has an outer expansion groove (5). The inner diameter of the outer expansion groove (5) is the same as the outer diameter of the annular hole protrusion (4). The height of the outer expansion groove (5) is lower than the height of the annular protrusion (4). The filter membrane (3) can be clamped between the annular hole protrusion (4) and the outer expansion groove (5).

2. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The diameter of the penetration hole is between 5 mm and 15 mm (inclusive).

3. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The height of the annular protrusion (4) is between 1.5 mm and 3 mm (inclusive), and the width of the ring is between 0.5 mm and 2 mm (inclusive).

4. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The height of the outer expansion groove (5) is 0.5 mm to 1.5 mm lower than the height of the annular protrusion (4).

5. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The upper plate (1) and the lower plate (2) are made of polystyrene, polypropylene or polyethylene.

6. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The material of the annular protrusion (4) is silicone, rubber or plastic.

7. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The upper plate (1) and the lower plate (2) have fastening devices (6) on their sides to fix the upper plate (1) and the lower plate (2) tightly together.

8. The high-throughput filter membrane screening plate according to claim 1, characterized in that, The filter membrane (3) is a cellulose membrane, a regenerated cellulose membrane, a nylon membrane, or a polyethylene membrane.

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