Importance

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Abstract

A method including: connecting, through a coupling line, a culture section where a culture step, in which cells are cultured in a culture liquid and the cells are removed from the culture liquid using a cell separation filter to obtain a culture supernatant liquid containing a product of the cells, is performed and a purification section where a purification step, in which the product is purified from the culture supernatant liquid to obtain an active pharmaceutical ingredient of a biopharmaceutical, is performed, the purification step including a purification step using a purification filter of a single pass tangential flow filtration method; providing, in the coupling line, a sterile filter having a pore diameter larger than a pore diameter of the cell separation filter; and filtering, with the sterile filter, the culture supernatant liquid flowing from the culture section to the purification section through the coupling line.

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First Claim