Abstract: The present invention relates to a computer implemented method for determining a weld integrity test result performed by a system configured to aseptically transferring cells to a container (BR), the method comprising welding (710) a vial to a connector to obtain a fluid-tight seal between the vial (V) and a connector (C), the connector being provided with a pair of conduits each having one end protruding through the connector and into the vial, sealing (720) an opposite end of one of the conduits, generating (730) a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit, measuring (740) a fluid pressure within at least one of the conduits, determining (750) a fluid pressure change based on the ambient pressure and the measured fluid pressure, determining (760) the weld integrity test result as pass or as fail based on the fluid pressure change.

Abstract: The present invention relates to an improved method for cell line development (CLD) which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site-directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI) and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts using SDI from that point on.

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: The present invention relates to an improved method for cell line development (CLD) which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site-directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI) and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts using SDI from that point on.

Abstract: The invention discloses a bioreactor with a vessel defining an inner volume, agitation means and at least one addition tube, wherein a delivery orifice in the addition tube is located within the inner volume and a check valve is arranged in proximity of the delivery orifice for allowing flow of a fluid in the direction from the addition tube into the inner volume of the vessel and blocking flow in the reverse direction.

Abstract: The invention discloses a bioreactor with a vessel defining an inner volume, agitation means and at least one addition tube, wherein a delivery orifice in the addition tube is located within the inner volume and a check valve is arranged in proximity of the delivery orifice for allowing flow of a fluid in the direction from the addition tube into the inner volume of the vessel and blocking flow in the reverse direction.

Abstract: The invention discloses a flexible bag assembly for cultivation of cells, comprising one or more bags forming a plurality of cultivation compartments, wherein a drain port in at least a first cultivation compartment is adapted to be fluidically connected with a second cultivation compartment upon opening of a valve means. It also discloses a bioreactor with the bag assembly mounted on a rocking tray and a method of cultivating cells in the assembly.

Abstract: The present disclosure is directed to method (100) for separating a biomolecule from a fluid (2), wherein the biomolecule is produced by biological cells in a perfusion bioreactor (3), the method comprising: forwarding (110) a product fluid comprising the biomolecule and biological cells from the perfusion bioreactor (3) during a bioreactor product output time period; loading (210) a first separation device (4) with the product fluid obtained in step (110) during a first separation loading time period, which constitutes a first part of a first separation cycle time period; pausing (130) the forwarding of the product fluid from the perfusion bioreactor during a bioreactor non-product output time period; and pausing (220) the loading of the first separation device (4) during a second part of the first separation cycle time period.

Abstract: A sparger assembly for a bioprocessing system includes a first layer having a plurality of pores of a first size, and a second layer disposed above the first layer and having a plurality of holes of a second size, the second size being greater than the first size. The pores of the first layer and the holes of the second layer allow for the passage of a sparge gas through the first layer and the second layer.

Abstract: A bioreactor system for culturing cells, comprising: —at least one bioreactor (3); and —at least one hydrocyclone (5a; 5b; 5c; 5d, 5d?; 5e) comprising: —a cell culture inlet (7) which is connected to a cell culture outlet (9) of the bioreactor (3) via a pump (11), whereby a cell culture from the bioreactor can be transferred to the hydrocyclone (5a: 5b; 5c; 5d, 5d?; 5e) when a cell culture is provided in the bioreactor, —a hydrocyclone separation part (13) into which cell culture can be introduced from the cell culture inlet (7), —a top outlet (15) through which a part of the cell culture with decreased cell concentration can be transferred after separation in the hydrocyclone separation pan (13); and —a bottom outlet (17) through which a pan of the cell culture with increased cell concentration can be transferred after separation in the hydrocyclone separation part (13), wherein said bottom outlet (17) of the hydrocyclone (5a; 5b; 5c; 5d, 5d?; 5e) is provided in a position such that when the bioreactor syste

Abstract: The present invention relates to a computer implemented method for determining a weld integrity test result performed by a system configured to aseptically transferring cells to a container (BR), the method comprising welding (710) a vial to a connector to obtain a fluid-tight seal between the vial (V) and a connector (C), the connector being provided with a pair of conduits each having one end protruding through the connector and into the vial, sealing (720) an opposite end of one of the conduits, generating (730) a fluid pressure different to an ambient fluid pressure at an opposite end of the other conduit, measuring (740) a fluid pressure within at least one of the conduits, determining (750) a fluid pressure change based on the ambient pressure and the measured fluid pressure, determining (760) the weld integrity test result as pass or as fail based on the fluid pressure change.

Abstract: The present invention relates to an improved method for cell line development which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI), novel design of the GO genome target location and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts from that point on.

Abstract: The invention discloses a method for virus clearance of a cell culture medium, comprising the steps of: i) providing a bulk medium portion, comprising amino acids and glucose, and a first additive portion, comprising vitamins in aqueous solution; ii) subjecting the bulk medium portion to a high temperature short time treatment (HTST); iii) passing the first additive portion through a virus retentive filter or an ultrafilter; and iv) after steps ii) and iii), mixing the bulk medium portion with the first additive portion to obtain a cell culture medium.

Abstract: The invention discloses a flexible bag for cell cultivation, comprising a cultivation compartment and at least one dialysis compartment, wherein the dialysis compartment(s) is/are delimited from the cultivation compartment by one or more dialysis membranes and is/are fluidically connected to a first and a second port in the bag.

Abstract: Provided is a bioreactor assembly that includes a plurality of cultivation bags at least one flexible temperature control bag having a thermostating fluid, and a tray adapted to rock back and forth around at least one axis. The flexible temperature control bag is mounted on the tray and the cultivation bags are located on the flexible temperature control bag.

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: The invention discloses a flexible bag assembly for cultivation of cells, comprising one or more bags forming a plurality of cultivation compartments, wherein a drain port in at least a first cultivation compartment is adapted to be fluidically connected with a second cultivation compartment upon opening of a valve means. It also discloses a bioreactor with the bag assembly mounted on a rocking tray and a method of cultivating cells in the assembly.

Abstract: The present invention relates to an improved method for cell line development (CLD) which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site-directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI) and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts using SDI from that point on.

Abstract: The invention discloses a flexible bag assembly for cultivation of cells, comprising one or more bags forming a plurality of cultivation compartments, wherein a drain port in at least a first cultivation compartment is adapted to be fluidically connected with a second cultivation compartment upon opening of a valve means. It also discloses a bioreactor with the bag assembly mounted on a rocking tray and a method of cultivating cells in the assembly.

Abstract: The present invention relates to an improved method for cell line development which is generally applicable to production of any therapeutic protein that can be produced using mammalian Cell lines and in particular Chinese Hamster Ovary (CHO) cells. The method combines site directed integration (SDI), expression construct components improving the post-transcriptional processing of the gene of interest (GOI), novel design of the GOI genome target location and the introduction of a onetime pre-CLD host cell line selection workflow to generate a production competent cell line that can then be used in multiple CLD efforts from that point on.