| abstract |
The invention relates to a method for continuously producing and/or preparing a biopharmaceutical biological macromolecular product from a heterogeneous cell culture/fluid mixture in a disinfected manner, having the following steps: (a) providing a particle-free fluid from a heterogeneous cell culture/fluid mixture, said fluid containing the product, in the form of a product flow, (b) carrying out at least one filtering process, whereby a filtrate is obtained, (c) carrying out at least two chromatography steps for cleaning the product, (d) carrying out at least one virus-removing process, and (e) carrying out at least one ultrafiltration process and/or at least one diafiltration process on the product flow from step (b), (c), and/or (d), said method being characterized in that the at least two chromatography steps from step (c) include a cleaning process using at least two respective chromatography columns and/or membrane adsorbers and in that the method is carried out in a closed and modular manner. The invention further relates to a corresponding modular system for carrying out the method. |