Hybrid system of culture and purification process for manufacturing antibody pharmaceuticals

A hybrid system of culture and purification processes for manufacturing antibody pharmaceuticals, comprising:

• one or more cultivation units including, as components for a culture process, a media preparation tank for preparing a medium in advance, a media hold tank for receiving the media from the media preparation tank and storing the medium, a feed line through which a feeding stream including thawed cells and a culture medium is introduced to a bioreactor, one or more bioreactors including a stirring system, which receives the thawed cells and the medium from the feeding stream and increases the number of cells through cell division, and a discharge line which discharges the medium containing the cells cultured in the bioreactor as an effluent stream;
• and
• one or more purification units including, as components for a purification process, a buffer preparation tank for preparing a buffer in advance, a buffer storage tank for receiving the buffer from the buffer preparation tank and storing the buffer, a chromatograph for removing impurities mixed in the medium using the medium received from the cultivation unit and the buffer transferred from the buffer storage tank to increase the purity of a target protein, and one or more filtration systems which are disposed before or after the chromatograph to perform buffer exchange and concentration,
• wherein among the components of the cultivation and purification units, one or more devices selected from the bioreactor, chromatograph and the filtration systems are formed of single-use (SU) disposable bags and stainless steel (SS), and one or more systems selected from the media preparation tank and the buffer storage tank are formed of a stainless steel (SS) material,
• wherein one cultivation unit and one purification unit, disposed on the same line, are configured as one suite unit, in which the cultivation unit and the purification unit are independently operated, and
• the cultivation unit in one suite unit is connected with two or more purification units selected from the same suite unit and another suite unit to prevent a downstream bottleneck phenomenon.