CN115261193A - Biological product concentration system and process thereof - Google Patents
Biological product concentration system and process thereof Download PDFInfo
- Publication number
- CN115261193A CN115261193A CN202210613503.0A CN202210613503A CN115261193A CN 115261193 A CN115261193 A CN 115261193A CN 202210613503 A CN202210613503 A CN 202210613503A CN 115261193 A CN115261193 A CN 115261193A
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- Prior art keywords
- sample tank
- filtering membrane
- product
- container
- concentration system
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Links
- 238000000034 method Methods 0.000 title claims abstract description 12
- 238000001914 filtration Methods 0.000 claims abstract description 69
- 239000012528 membrane Substances 0.000 claims abstract description 61
- 239000007853 buffer solution Substances 0.000 claims abstract description 24
- 238000007664 blowing Methods 0.000 claims abstract description 10
- 239000002699 waste material Substances 0.000 claims description 16
- 150000003384 small molecules Chemical class 0.000 claims description 14
- 239000000243 solution Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 238000010790 dilution Methods 0.000 claims description 8
- 239000012895 dilution Substances 0.000 claims description 8
- 238000005273 aeration Methods 0.000 claims description 5
- 238000007865 diluting Methods 0.000 claims description 3
- 238000011016 integrity testing Methods 0.000 claims description 3
- 239000010836 blood and blood product Substances 0.000 abstract description 3
- 229940125691 blood product Drugs 0.000 abstract description 3
- 229960005486 vaccine Drugs 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000005406 washing Methods 0.000 abstract 1
- 239000000047 product Substances 0.000 description 38
- 230000000694 effects Effects 0.000 description 7
- 238000012360 testing method Methods 0.000 description 6
- 238000010586 diagram Methods 0.000 description 3
- 239000012465 retentate Substances 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 238000007599 discharging Methods 0.000 description 2
- 239000000872 buffer Substances 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012263 liquid product Substances 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005374 membrane filtration Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
- -1 vaccines Substances 0.000 description 1
Images
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
- C12M33/14—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus with filters, sieves or membranes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
- C12M29/18—External loop; Means for reintroduction of fermented biomass or liquid percolate
Abstract
The invention discloses a biological product concentration system and a biological product concentration process. The system comprises a sample tank, a filtering membrane component, a circulating pipeline, a buffer solution container, a WFI container and an air blowing device; the outlet of the sample tank is connected with the inlet end of the filtering membrane component through a circulating pump, and the inlet of the sample tank is connected with the interception end of the filtering membrane component; two ends of the circulating pipeline are respectively connected with the outlet and the inlet of the sample tank through two valves, and the circulating pipeline is connected with the filtering membrane component in parallel; the inlet of the sample tank is respectively connected with the buffer solution container, the WFI container and the blowing device. The biological product concentration system and the process thereof are used for concentrating vaccines and blood products, and can be used for performing washing, filtering and replacement on concentrated products, so that the production requirements are met.
Description
Technical Field
The invention relates to the field of concentration equipment, in particular to a biological product concentration system and a biological product concentration process.
Background
The concentration and liquid change of biological products such as vaccines, blood products and the like are generally realized through cross-flow membrane filtration, in the filtration, small molecules (including water) permeate, macromolecular substances in stock solution are intercepted to realize the concentration effect, and materials are continuously circulated and filtered in a closed system formed by a sample tank, a pump, a membrane and a connecting pipeline, so that the removal effect of the small molecules is finally realized, and the target concentration is reached.
In the prior art, an outlet at the bottom of a sample tank is generally connected with an inlet of a filtering membrane component through a circulating pump, and a return end of the filtering membrane component is connected with an inlet of the sample tank, so that the concentrating equipment has some disadvantages in the application scene of high-multiple concentration, for example, the concentration of a buffer solution in a concentrated product is not changed, and therefore, the requirements on the dilution of the buffer solution and the replacement of the buffer solution after concentration cannot be met.
Also, to avoid introducing large amounts of air bubbles into the flow path during the recirculation filtration, the ultrafiltration sample tank will have a minimum working volume, wherein the larger the tank, the larger the minimum working volume, thereby limiting the number of times the sample is concentrated. The common solution in the prior art is to use two stages of concentration, one large and one small, but this adds significantly to the cost of the process. In addition, when the sample volume is reduced to the limit working volume, bubbles are easily drawn into the filtration flow path, and the shear force generated by bubble collapse easily causes structural change of biomolecules, thereby affecting the activity.
Disclosure of Invention
In order to solve the problems, the invention provides a biological product concentration system and a biological product concentration process.
According to one aspect of the invention, a biological product concentration system is provided, which comprises a sample tank, a filtration membrane module, a circulation pipeline, a buffer solution container, a WFI container and an air blowing device; the outlet of the sample tank is connected with the inlet end of the filtering membrane component through a circulating pump, and the inlet of the sample tank is connected with the interception end of the filtering membrane component; two ends of the circulating pipeline are respectively connected with the outlet and the inlet of the sample tank through two valves, and the circulating pipeline is connected with the filtering membrane component in parallel; the inlet of the sample tank is respectively connected with the buffer solution container, the WFI container and the blowing device.
In some embodiments, the filtration membrane module has a plurality of filtration membranes, and the circulation line is connected in parallel with one of the filtration membrane modules. Therefore, multiple times of filtration can be carried out on the product at a time by arranging a plurality of filtration membrane modules.
In some embodiments, the permeation section of the filtering membrane assembly is respectively connected with a small molecule collecting container and a waste discharge pipeline, and an ultraviolet sensor, a pH sensor and a pressure sensor are arranged on the small molecule collecting container. Therefore, the filtered micromolecules and the filtered waste can be respectively collected through the micromolecule collecting container and the waste discharge pipeline.
In some embodiments, the outlet of the sample tank is further connected to a concentrated solution collection container and a waste line through two valves. Thus, the concentrated solution and the remaining waste can be collected through the concentrated solution collecting container and the waste discharge pipeline, respectively.
In some embodiments, a transfer pump and a pressure sensor are provided on both the buffer container and the line connecting the WFI container to the sample tank. Thus, the delivery pump is used to provide the power for delivery and the pressure sensor is used to test the line pressure.
In some embodiments, the retentate end of the filtration membrane module is connected to an integrity test module via a valve. Thus, the integrity of the system pipeline can be tested by the integrity testing module.
According to one aspect of the present invention, there is provided a process of the above-mentioned bioproduct concentration system, comprising the steps of:
1) Circulating the product between the sample tank and the filtering membrane component for filtering, wherein small molecules in the product continuously flow out through the filtering membrane component until the volume of the product is concentrated to reach a set volume;
2) Continuously adding buffer solution and water into the sample tank through the buffer solution container and the WFI container, continuously replacing small molecules flowing out of the product and diluting until a target dilution factor is reached;
3) Collecting the product in the sample tank and the filtration membrane module.
In some embodiments, after step 1), the line between the inlet of the sample tank and the retentate end of the filtration membrane module is closed, the valve at both ends of the circulation line is opened, and product is circulated through flow filtration between the circulation line and the filtration membrane module in parallel therewith until the product is concentrated in volume to a target volume. Thus, the product can be further concentrated when desired using a recycle line.
In some embodiments, in step 3), the sample tank, the filtration membrane module and the product in the circulation line are collected by aeration through the aeration device. Thus, a specific manner of collecting the articles is described.
In some embodiments, the set volume in step 1) is 5% to 20% of the total volume of the product and the dilution factor in step 3) is 2 to 100. Thus, the set volume at which concentration is performed and the fold of dilution are described.
Drawings
FIG. 1 is a schematic diagram of a biological product concentration system according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a portion of the first bioproduct concentration system shown in FIG. 1;
FIG. 3 is a schematic diagram of a second partial configuration of the bioproduct concentration system shown in FIG. 1.
In the figure: the device comprises a sample tank 1, a filtering membrane component 2, a circulating pipeline 3, a buffer solution container 4, a WFI container 5, a blowing device 6, a concentrated solution collecting container 7, a waste discharge pipeline 8, an integrity testing module 9, a valve 10, a circulating pump 11, a small molecule collecting container 12 and a waste discharge pipeline 13.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings.
Fig. 1 schematically shows a structure of a biological product concentration system according to an embodiment of the present invention, fig. 2 shows a part of the structure of a biological product concentration system of fig. 1, and fig. 3 shows another part of the structure of a biological product concentration system of fig. 1. As shown in fig. 1-3, the system mainly comprises a sample tank 1, a filter membrane module 2, a circulation pipeline 3, a buffer solution container 4, a WFI container 5, and a blowing device 6, which are used for concentrating and replacing liquid products such as vaccines and blood products. In the present embodiment, the volume of the sample tank 1 is 3000L, and the membrane area of the filtration membrane module 2 is 80 square meters.
The sample tank 1 is vertically arranged, the inlet of the sample tank is positioned at the top, the outlet of the sample tank is positioned at the bottom, one end of the filtering membrane component 2 is an inlet end, the other end of the filtering membrane component is a trapping end, and the middle of the filtering membrane component is provided with a permeation section. Wherein, the bottom outlet of the sample tank 1 is connected with the inlet end of the filtering membrane component 2 through a circulating pump 11, while the inlet of the sample tank 1 is connected with the interception end of the filtering membrane component 2, and the connection can be closed according to the requirement.
The two ends of the circulation pipeline 3 are respectively connected with the outlet and the inlet of the sample tank 1 through two valves 10, and the circulation pipeline 3 is connected with the filtering membrane component 2 in parallel in terms of the sample tank 1. Specifically, one end of the circulating pipeline 3 is connected with a pipeline between the sample tank 1 and the circulating pump 11, the other end of the circulating pipeline is connected with a pipeline between the inlet of the sample tank 1 and the interception end of the filtering membrane component 2, and two valves 10 are respectively arranged at two ends of the circulating pipeline 3.
Preferably, in order to improve the single filtration effect, a plurality of filtration membrane modules 2 (two filtration membrane modules in the present embodiment) may be provided in series, and the circulation line 3 may be connected in parallel to only one of the filtration membrane modules 2.
The permeation section of the filtering membrane component 2 is respectively connected with a micromolecule collection container 12 and a waste discharge pipeline 13, the micromolecule collection container 12 is used for collecting filtered micromolecules (such as water, naCl and the like), and the waste discharge pipeline 13 is used for discharging filtered waste. Wherein, the small molecule collecting container 12 is further provided with an ultraviolet sensor, a pH sensor and a pressure sensor to detect the condition of collecting small molecules.
The top inlet of the sample tank 1 is connected with a buffer solution container 4 and a WFI container 5 respectively, wherein the buffer solution container 4 is used for containing buffer solution, the WFI container 5 is used for containing redistilled water, and a delivery pump and a pressure sensor are arranged on pipelines connected with the sample tank 1 and the buffer solution container 4 and the WFI container 5 respectively, so that the buffer solution and the water can be introduced into the sample tank 1 according to requirements.
The top inlet of the sample tank 1 is also connected to a gas blowing device 6, and the sample tank 1 can be ventilated by means of the gas blowing device 6.
Preferably, the bottom outlet of the sample tank 1 is further connected to a concentrated solution collecting container 7 and a waste discharge line 8 through two valves 10, respectively, the concentrated solution collecting container 7 collects concentrated solution, and the waste discharge line 8 is used for discharging concentrated waste.
Preferably, the retentate end of the filtration membrane module 2 is connected to an integrity test module 9 via a valve 10, and the integrity test module 9 can be used to test the dilution effect.
The use of the system comprises a number of steps, mainly as follows.
In the first step, the product is filtered and concentrated.
First, a set volume is set as the target volume of the product (e.g., 3 MNacl) after concentration, preferably 5% to 20% of the total volume of the product. The product is then introduced into the sample tank 1 and then sequentially passes through the filter membrane modules 2 and back into the sample tank 1 under the action of the circulation pump 11 (so that the product is filtered cyclically between the sample tank 1 and the filter membrane modules 2, wherein each cycle may be referred to as a single filtration.
During filtration, small molecules (such as water, nacl, etc.) in the product continuously flow out through the filtering membrane module 2 and are collected in the small molecule collecting container 12, and the volume of the product is continuously concentrated until the set volume is reached.
In addition, if the target volume of the concentrated product is too small, the target volume is difficult to reach only through the steps, a set volume which can be reached can be set, when the set volume is reached through the steps, a pipeline between an inlet at the top of the sample tank 1 and the filtering membrane component 2 is closed, valves 10 at two ends of the circulating pipeline 3 are opened, the product can circulate between the circulating pipeline 3 and the filtering membrane component 2 connected with the circulating pipeline in parallel under the action of the circulating pump 11, the product is repeatedly filtered and concentrated, and meanwhile, negative pressure is formed at the positions of the circulating pipeline 3 and the filtering membrane component 2, so that the product in the sample tank 1 is also drawn out for filtering and concentration.
And secondly, diluting the product.
Under the action of each delivery pump, buffer solution and water in the buffer solution container 4 and the WFI container 5 are continuously added into the sample tank 1, and with the progress of circulation filtration, small molecules in a product are continuously replaced by the buffer solution while being filtered and collected, and are diluted by the water, and finally a target dilution multiple (which can be selected to be 2-100) is achieved, so that a replacement effect is realized. The specific effect can be tested by the integrity test module 9.
And thirdly, collecting the product.
The aeration means 6 is opened to aerate the sample tank 1, thereby causing the product located in the sample tank 1, the filtration membrane module 2 and the circulation line 3 to flow and finally to be collected in the concentrate collection container 7.
What has been described above are merely some embodiments of the present invention. It will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention.
Claims (10)
1. A bioproduct concentration system characterized by: comprises a sample tank (1), a filtering membrane component (2), a circulating pipeline (3), a buffer solution container (4), a WFI container (5) and a blowing device (6);
the outlet of the sample tank (1) is connected with the inlet end of the filtering membrane component (2) through a circulating pump (11), and the inlet of the sample tank (1) is connected with the interception end of the filtering membrane component (2);
two ends of the circulating pipeline (3) are respectively connected with an outlet and an inlet of the sample tank (1) through two valves (10), and the circulating pipeline (3) is connected with the filtering membrane component (2) in parallel;
the inlet of the sample tank (1) is connected with the buffer solution container (4), the WFI container (5) and the air blowing device (6) respectively.
2. The bioproduct concentration system of claim 1, wherein: the filtering membrane module (2) is provided with a plurality of filtering membrane modules, and the circulating pipeline (3) is connected with one filtering membrane module (2) in parallel.
3. The bioproduct concentration system of claim 1, wherein: the permeation section of the filtering membrane component (2) is respectively connected with a micromolecule collection container (12) and a waste discharge pipeline (13), and the micromolecule collection container (12) is provided with an ultraviolet sensor, a PH sensor and a pressure sensor.
4. The bioproduct concentration system of claim 1, wherein: the outlet of the sample tank (1) is also connected with a concentrated solution collecting container (7) and a waste discharge pipeline (8) through two valves (10).
5. The bioproduct concentration system of claim 1, wherein: and a conveying pump and a pressure sensor are arranged on pipelines connected with the buffer solution container (4) and the WFI container (5) and the sample tank (1).
6. The bioproduct concentration system of claim 1, wherein: the interception end of the filtering membrane component (2) is connected with an integrity testing module (9) through a valve (10).
7. A process of a bioproduct concentration system of any one of claims 1 to 6, characterized by: comprises the following steps
1) Circularly filtering the product between the sample tank (1) and the filtering membrane component (2), wherein small molecules in the product continuously flow out through the filtering membrane component (2) until the volume of the product is concentrated to reach a set volume;
2) Continuously adding buffer solution and water into the sample tank (1) through the buffer solution container (4) and the WFI container (5), continuously replacing small molecules flowing out of a product and diluting until a target dilution multiple is reached;
3) Collecting the product in the sample tank (1) and the filter membrane module (2).
8. The process of claim 7, wherein the biological product concentration system comprises: after step 1), closing a pipeline between an inlet of the sample tank (1) and a cut-off end of the filtering membrane module (2), opening the valves (10) at two ends of the circulating pipeline (3), and circulating and filtering the product between the circulating pipeline (3) and the filtering membrane module (2) connected with the circulating pipeline in parallel until the volume of the product is concentrated to reach a target volume.
9. The process of claim 8, wherein the biological product concentration system comprises: in step 3), the sample tank (1), the filtration membrane module (2) and the product in the circulation line (3) are collected by aeration through the aeration device (6).
10. The process of claim 7, wherein the biological product concentration system comprises: the set volume in the step 1) is 5% -20% of the total volume of the product, and the dilution multiple in the step 3) is 2-100.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210613503.0A CN115261193A (en) | 2022-05-31 | 2022-05-31 | Biological product concentration system and process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210613503.0A CN115261193A (en) | 2022-05-31 | 2022-05-31 | Biological product concentration system and process thereof |
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| Publication Number | Publication Date |
|---|---|
| CN115261193A true CN115261193A (en) | 2022-11-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202210613503.0A Pending CN115261193A (en) | 2022-05-31 | 2022-05-31 | Biological product concentration system and process thereof |
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Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04293522A (en) * | 1991-03-20 | 1992-10-19 | Ngk Insulators Ltd | Cross flow filtration |
| CN101982222A (en) * | 2010-11-03 | 2011-03-02 | 合肥风云膜分离技术有限公司 | Device for continuously concentrating gelatin by membrane technology |
| CN102580534A (en) * | 2012-03-28 | 2012-07-18 | 于水利 | Concentrated solution backflow circulating type membrane separation equipment and method thereof |
| CN103657415A (en) * | 2013-12-26 | 2014-03-26 | 利穗科技(苏州)有限公司 | Ultrafiltration method for automatic ultra-filtering system under linear trans-membrane pressure |
| CN204294118U (en) * | 2014-12-12 | 2015-04-29 | 成都和诚过滤技术有限公司 | Film concentrates integral system equipment |
| CN104961797A (en) * | 2004-09-09 | 2015-10-07 | 健泰科生物技术公司 | Process for concentration of antibodies and therapeutic products thereof |
| CN107532122A (en) * | 2015-05-28 | 2018-01-02 | 株式会社日立制作所 | Liquid reflux vessel, cell concentration device and cell concentration system |
| CN113637586A (en) * | 2021-08-09 | 2021-11-12 | 上海纳米技术及应用国家工程研究中心有限公司 | Portable exosome preparation, enrichment, purification collection system of cultured cells |
| CN218579951U (en) * | 2022-05-31 | 2023-03-07 | 利穗科技(苏州)有限公司 | Biological product concentration system |
-
2022
- 2022-05-31 CN CN202210613503.0A patent/CN115261193A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04293522A (en) * | 1991-03-20 | 1992-10-19 | Ngk Insulators Ltd | Cross flow filtration |
| CN104961797A (en) * | 2004-09-09 | 2015-10-07 | 健泰科生物技术公司 | Process for concentration of antibodies and therapeutic products thereof |
| CN101982222A (en) * | 2010-11-03 | 2011-03-02 | 合肥风云膜分离技术有限公司 | Device for continuously concentrating gelatin by membrane technology |
| CN102580534A (en) * | 2012-03-28 | 2012-07-18 | 于水利 | Concentrated solution backflow circulating type membrane separation equipment and method thereof |
| CN103657415A (en) * | 2013-12-26 | 2014-03-26 | 利穗科技(苏州)有限公司 | Ultrafiltration method for automatic ultra-filtering system under linear trans-membrane pressure |
| CN204294118U (en) * | 2014-12-12 | 2015-04-29 | 成都和诚过滤技术有限公司 | Film concentrates integral system equipment |
| CN107532122A (en) * | 2015-05-28 | 2018-01-02 | 株式会社日立制作所 | Liquid reflux vessel, cell concentration device and cell concentration system |
| CN113637586A (en) * | 2021-08-09 | 2021-11-12 | 上海纳米技术及应用国家工程研究中心有限公司 | Portable exosome preparation, enrichment, purification collection system of cultured cells |
| CN218579951U (en) * | 2022-05-31 | 2023-03-07 | 利穗科技(苏州)有限公司 | Biological product concentration system |
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