Abstract: A method of predicting a parameter of a medium to be observed in a bioprocess based on Raman spectroscopy including the steps of acquiring a first series of preparatory Raman spectra of an aqueous medium using a first measuring assembly; normalizing the first series of preparatory Raman spectra based on a characteristic band of water from at least one Raman spectrum acquired with the first measuring assembly; building a multivariate model for the parameter based on the normalized preparatory Raman spectra; acquiring predictive Raman spectra of the medium to be observed during the bioprocess with another measuring assembly; normalizing the predictive Raman spectra based on a characteristic band of water from at least one Raman spectrum acquired with the other measuring assembly; and applying the built model to the predictive Raman spectra for predicting the parameter.

Abstract: The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

Abstract: The sealing arrangement includes a connecting device and one or more housing parts of a housing unit for enclosing of a component, typically an attachment component forming a head of the connecting device. The gas permeable end formed in such component can be isolated, so that the sealing arrangement is adapted for use in detecting a detectable gas in a hermetically sealed detection chamber. Thanks to a sealing structure configured at a passageway for the fastening of the connecting device, a housing unit is obtained with a tight radial contact around an intermediate portion of the connecting device. The device is fitted with a flexible hose end, preferably at a barbed nozzle forming the end at the opposite from the gas permeable end. With such arrangement, the hose mounting can be tested for its integrity.

Abstract: A disposable port device for connecting a functional unit to a flexible wall of a disposable container includes a flange to be connected to the flexible wall of the disposable container and an insert providing or receiving the functional unit. The flange and the insert are separate parts made from different materials with different material characteristics. A method of manufacturing such a disposable port device includes the steps of producing the flange from a first material, producing the insert from a different second material, the first and second materials having different material characteristics, and connecting the insert to the flange.

Abstract: Systems and methods for characterizing a plurality of particles suspended in a solution are described. In some embodiments, an ultrasonic interrogation signal may be emitted into a solution including a plurality of particles suspended in the solution. A resulting ultrasonic spectrum may be sensed and provided to a trained statistical model of the solution. The trained statistical model may then determine one or more properties of the plurality of particles.

Abstract: A bioreactor for use on a moving platform including a bag. According to a first aspect, the bag defines a three-dimensional geometrical shape including at least one lower collecting vertex in which at least two edges of the geometrical shape meet at an angle not greater than 90°. The bioreactor further includes at least one port or sensor arranged in the vicinity of the collecting vertex. According to a second aspect, the bag defines a two-dimensional geometrical shape or a three-dimensional geometrical shape. The geometrical shape includes at least one edge, in which at least two faces of the geometrical shape meet at an angle not greater than 90°. A longitudinal port/sensor element is arranged along the edge and includes several ports and/or sensors. A bioreactor motion system including a moving platform and a bioreactor according to the first or second aspect. A method of performing a bioprocess.

Abstract: A computer-implemented method for analysis of cell images comprises obtaining a deep neural network and a training dataset, the deep neural network comprising a plurality of hidden layers; obtaining first sets of intermediate output values that are output from at least one of the plurality of hidden layers; constructing a latent variable model using the first sets of intermediate output values, the latent variable model mapping the first sets of intermediate output values to first sets of projected values in a sub-space that has a dimension lower than the sets of the intermediate outputs; obtaining a second set of intermediate output values by inputting a received new cell image to the deep neural network; mapping, using the latent variable model, the second set of intermediate output values to a second set of projected values; and determining whether the received new cell image is an outlier.

Abstract: A bioreactor for culturing of microorganisms or cells comprising: a casing defining an interior space of the bioreactor, wherein said interior space is configured to receive and hold a culture medium with microbial or cellular liquid cultures; and at least one coupling element provided on the casing for coupling with a foam mitigation device for mitigation of foam built-up in the interior space of the bioreactor during use of the bioreactor for culturing of microorganisms or cells; wherein the coupling element is configured to allow ultrasonic waves generated by the foam mitigation device act upon foam built-up in the interior space of the bioreactor.

Abstract: A computer-implemented method for data analysis is provided.

Abstract: A configurable device for the flexible provision of connections and/or functions in a biopharmaceutical process includes a body in which predefined pipe sections and plug-in locations are formed by recesses in the material of the body. The configurable device further includes a plurality of functional elements which are adapted to be inserted into the plug-in locations.

Abstract: A protective container for a biopharmaceutical liquid bag comprises: a lower shell comprising a bottom and side walls; and an upper shell, said upper shell comprising a recess capable of covering the bag and being insertable in the lower shell, so that the upper shell is retained in the upper part of the side walls of the lower shell by resting on support elements located in the lower shell.

Abstract: The present invention relates to an adsorption medium including polymeric space elements which have been bonded to the surface of the chromatography matrix, and polymer chains containing chromatographically active centers, wherein the polymer chains have been bonded to the polymeric spacer elements, as well as to a method for the production thereof, and to the use of the adsorption medium for the purification of biomolecules.

Abstract: A modular processing system (100) for biopharmaceutical processes includes (i) at least one first and at least one second processing unit (30, 32), which can be fluidically connected to each other; and (ii) at least one adapter plate (200), through which at least one fluid flow (14), flowing from the first processing unit (30) to the second processing unit (32), can flow. The adapter plate deflects the fluid flow between the first processing unit and the second processing unit at least partially; and/or controls the fluid flow, preferably, the pressure thereof, in an open loop or closed loop manner. A method for the modular construction of a processing system (100) for biopharmaceutical processes is also disclosed.

Abstract: The invention relates to a filtration device and to a method for characterizing a filter medium or a medium to be filtered. The filtration device comprises a plurality of filtration units. Each filtration unit comprises a first container, which is designed to receive a medium to be filtered, a second container, which is designed to receive a filtrate, at least one connecting line, which connects the first container to the second container, and a filter medium between the first container and the second container in order to filter the medium to be filtered. The first container is designed for the application of positive pressure thereto, and the second container is designed to receive a measurement instrument at ambient pressure.

Abstract: A device for emptying a flexible bag comprising a fluid product, comprising a tray including a base having at least a top flat surface and two side members rigidly mounted on the base, perpendicularly to the base, the base being arranged substantially horizontally, namely along a front-rear direction and a left-right direction, a pressure element having at least a flat bottom face, for pressing downwards on a flexible bag under the influence of gravity. The tray includes guiding means for guiding the pressure element, as it goes downwards when the bag is emptying. The pressure element exhibits a gravity center and a geometric center, the gravity center being away from the geometric center.

Abstract: Computer-implemented monitoring of monoclonal quality of cell growth is specifically applicable to development of cell lines for the manufacturing of biopharmaceuticals. In one aspect, a computer-implemented method comprises: acquiring a sequence of images of a cell culture taken at different times during cell growth; processing each image in the sequence of images to identify cell locations of cells in the cell culture; determining for at least some of the images in the sequence of images the number of cells from the identified cell locations; determining for at least one image in the sequence of images a spatial distribution of cells from the identified cell locations; evaluating compliance of the determined numbers of cells and the determined spatial distribution of cells with predetermined evaluation conditions being characteristic of monoclonal growth; and assessing and outputting a monoclonal quality indicator based on the evaluated compliance with the predetermined evaluation conditions.

Abstract: The invention relates to an apparatus 10 for storing and/or processing at least one medium 11, in particular a bioprocessing device, comprising at least one disposable container 1, which is designed to accommodate at least some of the at least one medium 11, and at least one overpressure protection means 5, which is fluid-connected to the at least one disposable container 1. The at least one overpressure protection means is designed, when triggered, to conduct at least some of the at least one medium 11 into an apparatus region 3a? in front of the overpressure protection means 5 in relation to a flow direction F, in particular into the at least one disposable container 1 and/or into at least one further, second container 1a.

Abstract: A packaging for a flexible container, in particular for a disposable bag for use in a bioreactor, including a bottom part for fixing a first portion of the container, a ceiling part for fixing an opposite second portion of the container, a receiving space which on a first side is defined by the bottom part and on an opposite second side is defined by the ceiling part, and struts arranged between the bottom part and the ceiling part, which fix a defined distance between the bottom part and the ceiling part.

Abstract: The present invention relates to a method of expanding stem cells cultured as cell aggregates in a suspension culture changing culture medium and a method of medium exchange for the same cells characterized in the use of a rotating mesh such as a spinfilter device. The present invention further relates to a use of a rotating mesh for medium exchange in a suspension culture of stem cells.

Abstract: A device and a method for repeatedly modifying the composition of a fluid. The device includes a first module (19) modifying the composition of the fluid, a second module (21) modifying the composition of the fluid and a dwell module (20) with an inlet (8) and an outlet (10). The first module is connected in a fluid-conducting manner to the dwell module inlet and the dwell module outlet is connected in a fluid-conducting manner to the second module. Either the first or the second module is a filter unit, or the first module is a first filter unit and the second module is a second filter unit. The filter unit(s) include(s) at least one first filter medium (4, 14) delimiting a supply channel (2, 12) and a retentate channel (1, 11) and at least one second filter medium (5, 15) delimiting the retentate channel and a permeate channel (3, 13).