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          Solutions of Monoclonal Antibody Process Filtration

          Solutions of Monoclonal Antibody Process Filtration.jpg

          Membrane filtration is an indispensable step in the production of antibody drugs. It is used in a wide range of applications such as sterilization of culture media and buffers, rapid separation of cells from supernatant after culture media has been discharged from the tank and gas filtration in fermentation processes. For the production of antibodies, combinations of efficient and fast membrane filtration products, TFF systems and safe & reliable disposable solutions are available from Cobetter.


          Antibody is a Y-shaped protein produced by the body to stimulate effector B cells due to the invasion of foreign substances such as bacteria and viruses, etc. It consists of two heavy chains and two light chains, which are used by the immune system to identify and neutralize foreign substances. It also consists of two heavy chains and two light chains, which are used by the immune system to identify and neutralize foreign substances and are only found in body fluids such as blood of vertebrates and on the surface of the cell membrane of B cells.


          The monoclonal antibody technique was invented in 1975 by British scientists Milstein and Kohler, and won the 1984 Nobel Prize in Medicine. The development of monoclonal antibody drugs is only 45 years old and has become a global driver of biologic drug development due to its efficiency, targeting and low side effects. Seven of the top ten drugs sold worldwide are antibody drugs, with Chinese antibody drug sales reaching RMB 18 billion in 2019 and expected to reach RMB 30 billion in 2020.


          The monoclonal antibody drug process has also undergone rapid development in cell culture technology and downstream purification technology. In particular, upstream cell culture has developed from tens of mg/litre in the 1980s to more than 5g/litre today, which has greatly reduced the cost of cell culture. Downstream purification and capture stage of Protein A affinity packing not only greatly increased the load and flow rate, packing also developed from not resistant to alkali cleaning, to today can withstand 1mol NaOH. At the same time, in order to improve production efficiency, to ensure safety, pollution-free, disposable products are widely used in the production of many antibody processes.



          Solutions of Monoclonal Antibody Process Filtration-cbt.jpg

          ① Media Filtration       

          Bioburden Reduction and Particle Control

          Greclary CHV -Glass Fiber

          Safetect PME -PES

          Purcise PLE -Double Layer PES


          Sterilizing-grade Filtration

          Purcise SLE -Double Layer PES

          Purcise SPS -PES

          Corevital SMD -PVDF



          Mycoplasma Removal

          Purcise MLE -Double Layer PES



          ② Vent and Gas Filtration

          Safesure AFM -Hydrophobic PTFE

          Aegivast ACE -Hydrophobic PTFE

          Corevital APB -Hydrophobic PVDF



          ③ Buffer Filtration

          Purcise PLE -Double Layer PES

          Purcise PAF -PES

          Safetect PME -PES

          Corevital SAF -Double Layer PES

          Purcise SLE -Double Layer PES

          Purcise SPS -PES

          Corevital SMD -PVDF



          ④ Clarification Filtration

          Roheap CSD



          ⑤ Column / TFF Protection

          Clarification

          Greclary CHV -Glass Fiber

          Excesal CHE -PP

          Excesal CHC -PP
          Excesal CHT -PP


          Bioburden Reduction & Particle Control

          Purcise PLE -Double Layer PES

          Safetect PME -PES


          Sterilizing-grade Filtration

          Purcise SLE -Double Layer PES


          ⑥ Concentration and Purification

          Consieve?UET TFF 



          ⑦ Viral Remove Prefiltration

          Purcise SLE -Double Layer PES

          Purcise SPS -PES

          Purcise MLE -Double Layer PES



          ⑧ Virus Clearance

          Viruclear? -PES* (*Being Developed)



          ⑨ Sterile Filtration

          Purcise SLE -Double Layer PES

          Purcise SPS -PES




          • Corevital APB Filters Corevital APB capsule filters incorporated with hydrophobic PVDF membrane are especially designed for the sterile filtration of air and gas. These filter capsules provide high air flows and 100 % removal of bacteria from air and gases, even in the presence of high humidity and moisture. CorevitalTM APB Gas filter capsules could be integrated within gamma-irradiatable or gamma-sterilized complex systems such as biorectors, or transfer sets where venting is required.
          • Aegivast AFL filters Aegivast? AFL gas filters are made of 0.2μm-rated hydrophobic PTFE membrane, offering highest removal efficiency for bacteria and particulates from air and gas. Also the strong construction of Aegivast AFL gas filters offers enhanced steam resistance. Consequently, they are highly recommended for sterile filtration of gas, air in pharmaceutical, biological liquids and fermentation industries.
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