| 摘要 |
Batch method (M1) for preparing antibodies (Ab) by suspension culture of Ab-expressing cells, in a nutrient medium, in a reactor fitted with a material-exchange device having an exclusion limit below the molecular weight of Ab, with supply of exchange medium and removal of metabolic waste products, is new. Batch method for preparing antibodies (Ab) by suspension culture of Ab-expressing cells, in a nutrient medium, in a reactor fitted with a material-exchange device having an exclusion limit below the molecular weight of Ab, with supply of exchange medium and removal of metabolic waste products. In a start-up phase, the reactor is inoculated and exponential growth of the cells is initiated by stepwise addition of nutrient medium, to maintain cell density 0.1-5 million/ml. In a build-up phase, a defined volume of exchange medium is supplied to a circuit, so that the cell density does not fall below 0.1 million/ml (of suspension and medium in the circuit), and this phase is continued until cell density is at least 5/*10<6> /ml. Once this cell density is reached, the stationary phase is imposed by applying, and reversing in a rhythmic manner, a pressure gradient between the circuit and the reactor to cause material transport along this gradient. This results in transfer of nutrients into the reactor and of metabolic waste products into the circuit, from the reactor, with the volume exchange being 0.05-1 of suspension volume/day.
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