Abstract: Methods and apparatus for scaling in bioprocess systems are disclosed. An example apparatus for bioprocess scaling includes at least one memory to store instructions, and processor circuitry to execute the instructions to identify an operating parameter of a target bioreactor, determine an upper boundary or a lower boundary defining a design space for at least one bioreactor process parameter to match at least one of a first target parameter range or a second target parameter range based on the operating parameter, simulate changes in the first target parameter range or a second target parameter range based on an adjustment to the upper boundary or the lower boundary in the design space, and configure the target bioreactor using output obtained from the adjustment to the upper boundary or the lower boundary to identify a match between the first target parameter range or the second target parameter range.

Abstract: Cell culture apparatus is disclosed comprising: a cell culture container comprising a flexible tube; a support table; and a pair of opposed holders for holding opposed portions of the tube in a fluid tight manner such that fluid cannot pass through the respective portion inside the tube, the spacing between the said pair being adjustable to provide an adjustable sealed volume in the tube between the holder pair.

Abstract: A microfluidic device (100) is disclosed for in-process monitoring of cell culture conditions including for example one or more of: cell density; cell viability; secreted proteins; protein analysis; epitope markers; concentrations of metabolites or nutrients and antigenic determinations; the device comprising: a cell inlet path (120); plural fluid reservoirs (130) in fluid communication with the cell input path, a cell analysis area (160) in fluid communication with the path and reservoirs, and a waste storage volume (166) also in fluid communication with the cell analysis area, the device being operable to cause a primary fluid flow along the inlet path to the analysis area, and to selectively cause secondary fluid flow(s) into the path from none, one or more of the selected reservoirs to combine, if one or more of the reservoirs are selected, with the primary fluid flow from the cell inlet path, in each case for analysis at the cell analysis area, the device being further operable to cause a fluid flow of t

Abstract: The present invention relates to a method for predicting outcome of a process used for manufacturing a sample in a bioreactor, the process belonging to a category. The method comprises selecting (51) a process model based on the category; accessing (53) historic data related to past process runs for manufacturing the sample; accessing (53) current data obtained (54) from a current process run of the process. The obtained current data, which is based on the selected process model, comprises: process strategy data, bioreactor instrument data, data from online sensors and/or data from offline sensors. The method further comprises predicting (62) an outcome of at least one selected parameter of the current process run for manufacturing the sample based on the accessed historic data and current data. The present invention also relates to a method for modelling a process and a control system (10) for controlling a process.

Abstract: Cell culture apparatus is disclosed comprising: a cell culture container comprising a flexible tube; a support table; and a pair of opposed holders for holding opposed portions of the tube in a fluid tight manner such that fluid cannot pass through the respective portion inside the tube, the spacing between the said pair being adjustable to provide an adjustable sealed volume in the tube between the holder pair.