Pharmarceutical & Biology
Biological products refer to drugs prepared for the prevention, treatment and diagnosis of human diseases, and they are prepared from biological materials such as microorganisms, cells, tissues and liquid of various animals and human origin, which are obtained through genetic engineering, cell engineering, protein engineering, fermentation engineering and other biotechnology. Because biological products need go through multiple biological processes, purification processes for impurities removal, etc. to obtain the target products, biological products have extremely complex uncertainties in each link, and there are strict requirements for the quality control of biological products throughout the process, so filtration is very important to its process control.
1.Vaccine Filtration Solution
Vaccines refer to vaccine-based preventive biological products used for human vaccination in order to prevent and control the occurrence and prevalence of infectious diseases and refer to an automatic immune preparation for the prevention of infectious diseases that is made by pathogenic microorganisms (such as bacteria, rickettsia, viruses, etc.) and their metabolites through artificial attenuation, inactivated or transgenic methods. At present, most of the vaccines in use are used to prevent viral or bacterial infections, and they are mainly divided into inactivated vaccines, live attenuated vaccines, endotoxins, subunit vaccines, polysaccharide vaccines, nucleic acid vaccines (DNA vaccines and RNA vaccines) and so on.
In sterile pharmaceuticals, filtration technology plays a pivotal role in the quality of drugs as a means of reducing or removing microorganisms (bacteria, mycoplasmas, bacteriophages, endotoxins, etc.). It has a wide range of applications in different process stages of vaccine filtration, mainly including sterilizing filtration of culture medium, sterilization filtration of gas, sterilizing filtration of buffer fluid, clarification filtration of dead cells and cell debris, ultrafiltration concentration, chromatography purification, sterilizing filtration of terminal products, etc.
The main filtration sites are:
1. Filtration of medium: remove bacteria and microorganisms from cell culture medium
2. Gas filtration: remove microorganisms such as bacteria from gas
3. Filtration of buffer fluid: sterilizing filtration of buffer fluid, extend the service life of chromatography column and ultra-filtration membrane
4. Clarification filtration: removal of dead cells and cell debris as well as impurities such as lipids, colloids, particles
5. Security filtration: prefiltration before ultrafiltration to protect the ultrafiltration module
6. Terminal sterilizing filtration: remove bacteria and microorganisms from terminal filtrate
The process of traditional vaccine production and filtration is roughly as follows:
After understanding the process needs of customers, Membrane Solutions provides customers with stable and reliable products for a long time, and can provide perfect filter cartridge process validation. Membrane Solutions has a complete process Validation Service Center with complete management procedures, standard test procedures and standard operating specification, which is divided into core validation service center/process validation service center. It provides a variety of testing and validation services for pharmaceutical companies and filter manufacturers. Its validation support services simplify the validation process for customers in terms of filter regulations, making the entire vaccine preparation process more cost-effective and reliable. Its recommendations for the filtration and applications of the main sites in the production process of vaccine are as follows:
| Station | Membrane Solutions Recommended Filter Cartridge Series |
|---|---|
| ①Filtration of medium | Clarification filtration: |
| CRDS Series Depth Filter Sheets and Modules | |
| PolyPure-Classic Series（PPC Series）PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| PolyPure-AB Series（PPA Series） PP Pleated Filter Cartridge with Higher Removal Efficiency | |
| MedCap-UTC PPA Series PP High Flow-Rate Capsule Filter | |
| Bacteria reduction filtration: | |
| SteriPure Series（SP Series） PES Pleated Filter Cartridge with High Flow Rate and Long Service Life | |
| SteriPure-B Series（SPB Series） Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| PolymidPure Series（PN Series） Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance | |
| KynarPure-L Series（PVL Series） Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility | |
| MedCap-UTC PES Series PES Capsule Filter with High Flow Rate and Long Service Life | |
| Sterilization filtration: | |
| SteriPure-B Series（SPB Series） Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| SteriPure-P Series（SPP Series） Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
| PolymidPure Series（PN Series） Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance | |
| KynarPure-L Series（PVL Series） Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility | |
| MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency | |
| ②Gas, respirator | FluorPure-BG Series（FBG Series） Cost-effective PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements |
| FluorPure-SG Series（FSG Series） PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements | |
| FluorPure-DG Series（FDG Series） Double-layer PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements | |
| MedCap-UTC PTFESG Series PTFE Sterile-grade Capsule Filter with High Retention Efficiency and High Flux | |
| ③Filtration of buffer fluid | Prefiltration: |
| PolyPure-Classic Series（PPC Series）PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| PolyPure-AB Series（PPA Series） PP Pleated Filter Cartridge with Higher Removal Efficiency | |
| SteriPure Series（SP Series） PES Pleated Filter Cartridge with High Flow Rate and Long Service Life | |
| MedCap-UTC PES Series PES Capsule Filter with High Flow Rate and Long Service Life | |
| Sterilization filtration: | |
| SteriPure-B Series（SPB Series）Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| SteriPure-P Series（SPP Series）Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
| PolymidPure Series（PN Series） Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance | |
| KynarPure-L Series（PVL Series）Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility | |
| MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency | |
| ④Clarification filtration | CRDS Series Depth Filter Sheets and Modules |
| PolyPure-Classic Series（PPC Series）PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| PolyPure-AB Series（PPA Series）PP Pleated Filter Cartridge with Higher Removal Efficiency | |
| MedCap-UTC PPA Series PP High Flow-Rate Capsule Filter | |
| ⑤Security filtration | NMO Series Nylon Monofilament Filter Bag |
| Needle Felt Filter Bag（PP/PE/PTFE Series） | |
| MicroPure Classic Series PP Melt Blown Filter Cartridge | |
| PolyPure-Classic Series（PPC Series）PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| MS 600 FlowPure-HF Pleated Filter Cartridge with High Flow | |
| ⑥Terminal sterilization filtration | SteriPure-B Series（SPB Series）Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency |
| SteriPure-P Series（SPP Series）Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
| PolymidPure Series（PN Series）Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance | |
| KynarPure-L Series（PVL Series）Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility | |
| MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency |
For detailed technical solutions, please contact your MS sales engineer.
2.Monoclonal Antibody Filtration Solution
Monoclonal antibody (mAb) is a highly homogeneous antibody produced by B cells that only targets a specific antigenic epitope. It is a “Y” shaped immunoglobulin used to identify and eliminate foreign substances such as bacteria, viruses, etc. The main applications of mAb are laboratory medical diagnostic reagents, protein purification, targeted treatment of tumors and radioimmunoassay techniques.
In 1975, British scientists Kohler and Milstein first fused mouse myeloma cells with long life but unable to produce specific antibodies with plasma cells with short life but able to produce specific antibodies after immunization (mouse spleen cells immunized with sheep red blood cells) in vitro, and created the hybridoma technology. Thanks to this technology, mAbs have achieved a large number of preparation for basic research and have the capability of clinical transformation, opening a new era in the development of monoclonal antibody drugs. The classic preparation method of monoclonal antibodies is to inject specific antigens into mice to induce immune response, and obtain corresponding B lymphocytes, which are fused with mouse myeloma cells. After screening, the obtained hybridoma cells are cultured on a large scale in vitro to amplify monoclonal antibody.
The production process of monoclonal antibodies mainly includes the cultivation process of upstream cells, the harvesting and clarification process of cell culture medium, and the downstream separation and purification process. Filtration has a wide range of applications in different process stages, mainly including sterilizing filtration of culture media, gas, buffer, clarification filtration of dead cells and cell fragments, ultrafiltration concentration, chromatography purification, sterilizing filtration of terminal product, and virus removal filtration.
The main filtration sites are:
1. Filtration of medium: remove bacteria and microorganisms from cell culture medium
2. Respirator/Gas filtration: the sterilizing filtration of gas is mainly applied to the intake and exhaust filtration of bioreactors, as well as the respirators of various storage tanks and ingredient tanks, mainly to remove bacteria and other microorganisms in the gas
3. ATF: tangential flow filtration to remove dead cells and cell fragments, as well as impurities such as lipids, colloids, and particles
4. Buffer filtration: sterilizing filtration of buffer, extending the service life of the chromatography column and ultrafiltration membrane
5. Security filtration: prefiltration before ultrafiltration to protect the ultrafiltration module
6. Terminal sterilizing filtration: remove bacteria and microorganisms from terminal filtrate
The process and production flow of monoclonal antibody is roughly as follows:
After understanding the process needs of customers, Membrane Solutions provides customers with stable and reliable products for a long time, and can provide perfect filter cartridge process validation. Membrane Solutions has a complete process Validation Service Center with complete management procedures, standard test procedures and standard operating specification. It provides a variety of testing and validation services for pharmaceutical companies and filter manufacturers. Its validation support services simplify the validation process for customers in terms of filter regulations. Its recommendations for the filtration and applications of the main sites in the production process of monoclonal antibody are as follows:
|
Station |
Membrane Solutions Recommended Filter Cartridge Series |
|
①Filtration of culture medium |
Clarification filtration： |
| MicroPure Classic Series PP Melt Blown Filter Cartridge | |
| PolyPure-Classic Series (PPC Series) PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| Bacteria reduction filtration： | |
| SteriPure Series (SP Series) PES Pleated Filter Cartridge with High Flow Rate and Long Service Life | |
| SteriPure-B Series (SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| SteriPure-P Series (SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
| MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency | |
| MedCap-UTC PVL Series Sterile-grade Capsule Filter with Low Precipitation and Low Protein Binding | |
|
②Gas/Respirator |
FluorPure-BG Series (FBG Series) Cost-effective PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements |
| FluorPure-SG Series (FSG Series) PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements | |
| MedCap-UTC PTFESG Series PTFE Sterile-grade Capsule Filter with High Retention Efficiency and High Flux | |
|
③ATF |
Hydrophilic modified PES hollow fiber membrane |
|
④Filtration of buffer |
Prefiltration： |
| PolyPure-Classic Series (PPC Series) PP Pleated Filter Cartridge with High Flux and High Flow Rate | |
| SteriPure Series (SP Series) PES Pleated Filter Cartridge with High Flow Rate and Long Service Life | |
| Sterilizing filtration: | |
| SteriPure-B Series (SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| SteriPure-P Series (SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series (SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
|
⑤Pre-column security filtration |
SteriPure Series (SP Series) PES Pleated Filter Cartridge with High Flow Rate and Long Service Life |
| SteriPure-B Series (SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency | |
| SteriPure-P Series (SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series (SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
|
⑥Sterilizing filtration |
SteriPure-B Series (SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency |
| SteriPure-P Series (SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency | |
| SteriPure-D Series (SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency | |
|
MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency |
|
| MedCap-UTC PVL Series Sterile-grade Capsule Filter with Low Precipitation and Low Protein Binding |
Products About Pharmarceutical & Biology
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FluorPure-DG Series Double-layer PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FDG series PTFE pleated filter cartridge is made of double-layer sterile-grade PTFE membrane, which has higher retention efficiency and can meet the requirements of phage retention and other harsh conditions to provide extremely reliable sterility guarantee for gases.
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FluorPure-SG Series PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FSG series PTFE pleated filter cartridge is made of strong hydrophobic and uniformly distributed pore size PTFE membrane. Its proven sterilization ability and stable chemical properties enable the filter to provide excellent sterility protection for high humidity gas and low surface tension liquid even after 150 times of moist heat sterilization at 121℃.
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PPA High Flow-rate Capsule Filter
PPA series PP pleated capsule filter is made of polypropylene microfiber. It has a gradient pore size and a high strength support, which makes the filter has the characteristics of high retention efficiency and high flow rates, and is especially suitable for clarification filtration of liquid and pre-filtration of gas. PPA series capsule filter is available in a wide range of removal ratings and in a wide range of cages and connections to meet the needs of different applications, widely used in bio-pharmacy and food and beverage.
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MicroPure Classic Series PP Melt Blown Filter Cartridge
PP melt blown filter cartridge is made of 100% pure PP particles without any adhesive, and is made by fiber hot-melt entanglement. The unique three-layer gradient pore size design forms a three-dimensional slag filtering effect, which has the characteristics of high porosity, high retention efficiency, high dirt holding capacity and low pressure difference. The pure PP structure makes it have extensive chemical compatibility and is suitable for the filtration of strong acid, strong alkali and organic solvents. The advanced fiber hot-melt technology can meet the various needs of customers for this product.
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New Product Express | Membrane Solutions Prism TM 50 Tangential Flow Cassette
Tangential flow filtration is one of the key separation and purification technologies in the biopharmaceutical process. It is widely used in the fields of antibody, vaccine, gene and cell therapy and nucleic acid drugs, and is the main means of drug molecular concentration and buffer replacement. In this article, we will take you to have a brief understanding of the relevant knowledge of tangential flow filtration, and introduce the company's latest product Prism TM 50 tangential flow cassette.
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NMO Series Nylon Monofilament Filter Bag
Nylon monofilament filter bag is made of filter material woven by a single nylon fiber, and the structure is welded and fused or wire stitched. It has good compressive strength, smooth surface and is not easy to deform, easy to clean and can be used repeatedly. It is suitable for the fields with low removal rating requirements such as coarse filtration or prefiltration as well as liquid filtration with high impurity content.
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PolymidPure Series Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance
PolymidPure Nylon 6,6 membrane pleated filter cartridge uses a controlled porosity and naturally hydrophilic Nylon 6,6 membrane, which contains any wetting agents, has excellent chemical compatibility and mechanical strength. After special cleaning steps, the filter membrane has low precipitation and no shedding. It can be widely used in the filtration of strong alkali, weak acid and organic solvents. High quality all-polypropylene components and high strength Nylon 6,6 membrane with polyester support layer have excellent heat and pressure resistance and meet the requirements of most applications. PolymidPure can provide a sterilizing-grade filter cartridge with double layer 0.2μm membrane. A validation guide for compliance with regulatory requirements is available.
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KynarPure-L Series Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility
PVL series PVDF pleated filter cartridge is made of unlined hydrophilic PVDF membrane. The filter membrane has the characteristics of symmetrical pore type, uniform hydrophilicity, high porosity and extremely low protein binding, which make the filter cartridge is easy to use without pre-wetting. The filter cartridge is suitable for the sterilization filtration of various biological products.