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