Conference Dates

October 9 – 13, 2022


As downstream process (DSP) of monoclonal antibody (mAb) includes several batch chromatography steps, and other operations such as virus inactivation (VI), it is important to consider how each operation is carried out in order to make an efficient continuous or pseudo-continuous DSP. Our consortium* developed a continuous DSP (CDSP) of mAb under the AMED** project “Development of platform technologies for the continuous manufacturing of biopharmaceuticals”, and successfully carried out several runs at our GMP facility and laboratory. In this paper, we will present how our CDSP was developed based on the process analysis and understanding, and the purification results along with several important issues to be addressed in the future [1].

For the first “capture” step, a 2-column “periodic counter-current chromatography (PCCC)” with protein A chromatography columns was chosen. The efficiency of PCCC is strongly dependent on the operating conditions, which should be determined properly [2, 3].

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