Continuous production pharmaceutical technology is an emerging technology, although still facing many regulatory issues and technical challenges, but the superiority of continuous production is obvious, but also the general trend of the development of the biopharmaceutical process, can improve the robustness and reliability of the production process, reduce production and fixed asset expenditures, reduce the time to build the plant, and reduce the time required for product replacement in production. At the same time, domestic biopharmaceuticals started late, the application of continuous production process technology will be a breakthrough for China's biopharmaceuticals to gain a competitive advantage. At this stage, domestic and foreign countries are basically in the same starting line, such as seizing the opportunity to prioritize the development and use of continuous production process, will be able to play the advantage of latecomer, improve production efficiency and reduce production costs.

Perfusion culture technology belongs to continuous culture, is to enhance the efficiency of the cell culture process, to improve the recombinant protein, especially monoclonal antibody products, the unit volume of production and quality of an important means of its development over a considerable period of time, has been widely adopted by biopharmaceutical companies. Cell perfusion culture is considered to be the "only" upstream bioprocess can be realized continuous technology, so with the promotion of continuous process, the use of perfusion is also the inevitable path of the future.

Clarification of the culture after completion of the process is commonly used in this stage, such as centrifugation and deep filtration. etc. The traditional centrifugation method operates in a batch mode and requires periodic slag removal, which leads to an increase in manpower and material resources, as well as interruption of the process. Deep filtration is achieved by using disposable membrane stacks, which are single-use and do not allow for process continuity.

The retention of cells and bacteria by tangential flow filtration to achieve the purpose of clarification can realize the continuous automated production of the process, reduce human error, and avoid problems caused by personnel operation. At the same time this program can reduce manpower and material resources, and reduce operating costs.

The realization of the above processes, all using tangential flow filtration process instead of the traditional process, the use of hollow fiber membrane to achieve continuous production of biopharmaceutical processes.

Asahi Kasei Hollow Fiber Membrane has uniform pore size, good chemical resistance and can be backflushed. Reverse flushing, and some models can realize SIP, so it is very suitable as the core component of tangential flow filtration to replace the traditional process.

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