Abstract: A single-use device for filtration of a large volume of medium including a plurality of single-use filter units, at least some of which, preferably all of which, are connected to each other by rigid pipes. The filter units include at least one prefilter and at least one main filter for virus filtration which is configured as a hollow fiber capsule.

Abstract: An organizer assembly including a belt and a ribbon. The ribbon has a first clamp member, a second clamp member, and a first carrier portion. The first clamp member is configured to receive a conduit or a support to fix the conduit or the support relative to the ribbon. The belt includes an elongated body that is slidably received in the first carrier portion. The organizer assembly may include one or more adapters that are received in a respective clamp member of the ribbon and configured to receive a conduit or a support to fix the conduit or support relative to the ribbon.

Abstract: Method for open-loop or closed-loop control of a process, in particular a downstream bioprocess, based on the projection of an unknown concentration of at least one substance in a sample using spectroscopy, in particular UV/vis spectroscopy, comprising the steps: Detect spectrums of a plurality of concentration samples, wherein at least two concentration samples have differing concentrations of the substance; generate several quantitative models based on the spectrums of the concentration samples, wherein the models each have a mapping of at least one spectral measurand of the spectrums to concentrations in concentration ranges, wherein the concentration ranges of two models are not identical; detect at least one sample spectrum of the sample; map the sample spectrum to at least one quantitative model of the generated quantitative models; apply the at least one quantitative model that was mapped to the sample spectrum against the sample spectrum to determine a projected value for the unknown concentration; an

Abstract: A crossflow filtration unit for continuous diafiltration of a feed fluid for obtaining a retentate and a permeate, a corresponding method for diafiltration and the use of the crossflow filtration unit are provided. The crossflow filtration unit includes a diafiltration channel, a flat first filter material, a retentate channel, a flat second filter material, and a permeate collection channel, arranged such that the flat first filter material delimits the diafiltration channel and the retentate channel from one another, and the flat second filter material delimits the retentate channel and the permeate collection channel from one another. The diafiltration channel is fluidly connected to at least one inlet for the diafiltration medium, the retentate channel is fluidly connected to at least one inlet for the feed fluid and to at least one outlet for the retentate. The permeate collection channel is fluidly connected to at least one outlet for the permeate.

Abstract: Techniques for predicting an amount of at least one biomaterial produced or consumed by a biological system in a bioreactor are provided. Process conditions and metabolite concentrations are measured for the biological system as a function of time. Metabolic rates for the biological system, including specific consumption rates of metabolites and specific production rates of metabolites are determined. The process conditions and the metabolic rates are provided to a hybrid system model configured to predict production of the biomaterial. The hybrid system model includes a kinetic growth model configured to estimate cell growth as a function of time and a metabolic condition model based on metabolite specific consumption or secretion rates and select process conditions, wherein the metabolic condition model is configured to classify the biological system into a metabolic state. An amount of the biomaterial based on the hybrid system model is predicted.

Abstract: An assembly is provided that comprises at least one valve unit (20, 30) comprising a plurality of valves (25), the at least one valve unit (20, 30) having a plurality of valve unit protrusions (32) extending in a first direction and at least one valve unit fastener-engaging component (36); a valve control block (10) configured to open and close the plurality of valves (25), the valve control block (10) comprising a plurality of pins (15) extending in the first direction (A); and at least one thrust plate (40) comprising a plurality of thrust plate protrusions (42), a plurality of thrust plate apertures (44) configured to receive the plurality of pins (15) and at least one thrust plate fastener-engaging component (46); wherein: the at least one valve unit (20, 30) further comprises a plurality of fitted through-holes configured to receive the plurality of pins (15) and the at least one valve unit (20, 30) is positioned adjacent to the valve control block (10) in the first direction (A); the at least one t

Abstract: Methods for monitoring, controlling and simulating a bioprocess comprising a cell culture in a bioreactor are provided. The methods comprise obtaining values of one or more process conditions for the bioprocess at one or more maturities, and determining the specific transport rates of one or more metabolites in the cell culture using the values obtained as input to a machine learning model trained to predict the specific transport rates of the one or more metabolites at a latest maturity of the one or more maturities or a later maturity based at least in part on the values of one or more process conditions for the bioprocess at the one or more preceding maturities. The methods further comprise predicting one or more features of the bioprocess based at least in part on the determined specific transport rates. Systems, computer readable media and methods for providing tools to implement such methods are also provided.

Abstract: A computer-implemented method for simulating a cell culture process is provided.

Abstract: A protecting device is provided, having two plates forming a rectangular protecting body for sandwiching, constraining and protecting a flexible pouch. The two plates are attached together at a peripheral margin. Each plate has an outer surface with ribs provided in a peripheral annular region of a covering part receiving the pouch, along the peripheral margin. The peripheral margin is mounted in supporting parts of a frame and sliding positioning members may be secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar, at least at panel parts surrounded by the ribs. This allows for progressive conformational change of the protecting body when filling the pouch with biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

Abstract: A freeze/thaw containment system is provided, having a protecting body and a flexible pouch, of a first capacity, protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in a stationary frame and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch. One amongst the stationary frame and the protecting body includes fastening members for attachment of a casing configured for storing the bag, in order to have the bag fastened parallel to the protecting body. Two fasteners for cooperating with the fastening members are distributed around a bag containing part of a second capacity at least ten times inferior to the first capacity. Same biopharmaceutical composition is contained in the pouch and in the bag.

Abstract: A sterile packaging unit includes a disposable bioprocessing component (20) and a packaging (30). The disposable bioprocessing component (20) has a component wall that encloses a processing space and on which is secured a sensor system (40) with at least one sensor head (T, P, I, L, D) and with attached sensor electronics (42) that include a memory unit (44). The packaging (30) hermetically encloses the disposable bioprocessing component (20) and has a flexible packaging wall. The disposable bioprocessing component (20) and the packaging (30). are sterilized by being jointly irradiated with ionizing radiation. The sensor electronics (42) are connected electrically to a contact unit (34) extending through the packaging wall.

Abstract: A method of aseptically distributing fluid to a plurality of vessels includes securing the plurality of vessels relative to a hub and flowing fluid through an input tube into a plenum of the hub such that a substantially equal amount of fluid flows from the plenum into each of the vessels simultaneously. The vessels are positioned in the same plane relative to one another with each vessel having an inflow conduit extending from the hub to the vessel such that an arc segment is formed between the hub and the vessel.

Abstract: A freeze/thaw containment system is provided, having a protecting body and a flexible pouch protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in supporting parts of a stationary frame and sliding positioning members are secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch in empty state of the pouch. This way of holding and retaining the protecting body allows for progressive conformational change of the protecting body due to the change in volume of the pouch when filled with a biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

Abstract: A filter module for sterile filtration and virus filtration of fluid media. The filter module includes a filter membrane with a porous edge structure arranged thereon and at least one anchoring element. The filter membrane with the porous edge structure is embedded in the anchoring element and serves as edge reinforcement to improve the connection of the filter membrane to the anchoring element. The texturing or surface roughness of the edge reinforcement provides an interlocking effect between the filter membrane and the anchoring element. The embedding of the filter membrane in the anchoring element provides a fluid-tight connection of the membrane to the anchoring element which prevents the occurrence of leaks in the end region of the filter module. A method for producing the filter module is also described.

Abstract: A thermal capacitor includes a shell and a PCM. The shell includes a first major surface that is configured to contact a container including media to be frozen. The shell defines a cavity in which the PCM is disposed. The PCM has a transition temperature in a range of ?80 degrees Celsius to ?50 degrees Celsius and is configured to rapidly freeze media from room temperature to ?60 degrees Celsius with the container including the media in contact with the shell in an enclosed space.

Abstract: A carrier for receiving a vessel includes a body that defines a well. The well is sized and dimensioned to receive a vessel including media. The body is configured to urge the vessel received in the well towards an external wall of the body to enhance thermal energy transfer into or out of the media within the vessel. A box assembly for supporting media during thermal changes includes a box, a vessel, and a carrier is also disclosed.

Abstract: The present invention relates to a method of changing culture medium of a suspension culture, the suspension culture comprising cells suspended in the culture medium, the method comprising: (i) transferring a fraction of the suspension culture into a container, wherein the container comprises at least one opening at the bottom; (ii) allowing the cells comprised in the fraction of the suspension to settle at the at least one opening at the bottom of the container by gravitation, thereby forming a supernatant; (iii) dispensing the cells settled at the bottom of the container (back) into the suspension culture; (iv) discarding the supernatant.

Abstract: The invention relates to a modular processing system for biopharmaceutical and/or chemical processes, comprising: at least one processing unit; at least one adapter plate, which can be directly or indirectly fluidically connected to the processing unit, wherein the adapter plate has at least one adapter channel, through which at least one fluid flow can flow to the processing unit, wherein the adapter plate also has at least one deflection element and/or a pump and/or at least one valve; and an external control device. The adapter plate is designed in such a way that the fluid flow to the processing unit can be at least partially deflected with the at least one deflection element in the adapter channel and/or the fluid flow, preferably its pressure, is controllable with the at least one valve and/or the pump in the adapter channel.

Abstract: A computer implemented and a system for adapting control of a cell culture in a production-scale vessel with regard to a starting medium are provided. The method comprises providing multiple production-scale process trajectories, receiving a media lot for the cell culture, and sampling first media from the media lot for possible use in the production-scale vessel. The method also comprises starting a seed train using the first media to achieve inoculation of the production-scale vessel, providing a plurality of micro-scale vessels in a process control device, and sampling second media from the media lot for the micro-scale vessels. Cells from the seed train can be introduced into the micro-scale vessels to start cell cultures in each of the micro-scale vessels.

Abstract: A filter module (10) has a housing (12) which is subdivided by a membrane filter (14) into an inlet chamber (16), which is connected to an inlet connecting piece (22) arranged rigidly on the housing (12), and an outlet chamber (18), which has a filtrate outlet (20). The inlet connecting piece has two connectors, specifically a first connector (26) and a second connector (28), which connect selectively and fluidically to the inlet chamber with a 3-way valve (24) integrated into the inlet connecting piece. The valve has a first entry, which is connected to the first connector, a second entry, which is connected to the second connector, and an exit, which is connected to the inlet chamber. The first connector is configured as an adapter for outwardly sealed coupling of a culture medium bottle (30), which coupling permits a gravity-driven exchange of liquid with the first entry of the valve.