Abstract: The present invention relates to the field of radiopharmaceuticals for in vivo imaging, in particular to a method of labelling a biological targeting molecule with the radioisotope 18F. The invention provides a method of preparation of lyophilised compositions of aminooxy-functionalised biomolecules, as well as radiolabelling methods using the purified materials. Also provided are lyophilised compositions and cassettes comprising such purified compositions. The invention is particularly suitable for use with an automated synthesizer apparatus.

Abstract: The present invention discloses a flow cell optical detection system comprising a light source, a flow cell and a light detector, wherein the light detector is arranged in a separate detector unit that is arranged to be releasably attached to a detector interface, the detector interface being in optical communication with the light source and comprises optical connectors for optically connecting the flow cell and the detector unit in the light path from the light source, and wherein the flow cell is an interchangeable unit arranged to be held in position by the detector unit when attached to the detector interface.

Abstract: Methods and systems for chromatography are disclosed that employ a flexible container configured to fit within a support structure and adapted to receive a filtration or absorptive medium. The flexible container can include at least one inlet, at least one outlet, and a separation barrier peripherally sealed within the container to separate the container into a resin containing portion and a drainage portion. The barrier can be configured to exclude the resin material from the drainage portion while allowing fluids to pass therethrough. The disposable chromatography system can further include one or more agitators disposed within the flexible container and adjustably configured to be raised or lowered in the flexible container. When the agitator is in the raised position, the resin packing material can operate in a settled, packed-bed configuration. Alternatively, the agitator in the lowered position permits the chromatography resin packing material to operate in a mixed, slurry configuration.

Abstract: A method of determining one or more interaction parameters for the interaction between an analyte and a ligand using a biosensor, which comprises the steps of: A: providing a sensor surface having the ligand immobilized thereto, B: contacting the sensor surface with a control analyte, C: registering the sensor response from binding of the control analyte to binding sites of the ligand, D: determining the control saturation response (RmaxC) for the interaction between the control analyte and the ligand, E: transforming the control saturation response (RmaxC) to an analyte saturation response (RmaxA) using the relative molar response contribution of the analyte and the control analyte.

Abstract: The present invention relates to a novel chromatography media, more closely a novel IMAC (Immobilized Metal Affinity Chromatography) media. The novel chromatography media comprises a pentaligand and provides high dynamic binding capacity as well as high purity of the sample proteins purified on the media of the invention.

Abstract: The present invention relates to systems and methods to facilitate replacement between runs of a kit or cassette from an automated radiosynthesis device located in a hot cell. The method and apparatus of the invention enable automated disconnection of the outlet line by sealing the tubing hermetically by means of heat and by cutting the tubing where it is sealed in such a way that there is no risk of environmental contamination with radioactive material. The invention enables disconnection of the outlet line without manual intervention before opening the shielded enclosure.

Abstract: The invention relates to valve system for controlling a process fluid within a liquid processing system. The valve system comprises a valve arrangement, a pneumatic control system, and a connector unit. When the valve arrangement is connected to the connector unit, two or more valves are formed, such that the pneumatic control system controls an open/close or pressure control mode of the valves. A pump diaphragm system is disclosed, as well as a system for purifying a biological material that comprises the valve system or the pump diaphragm system. Also discloses are methods of using the valve system or the pump diaphragm system in a process for the purification of a biological material.

Abstract: The present invention provides a system for the production of a radiopharmaceutical including a radiosynthesis apparatus and a disposable cassette. The system of the invention includes a device that enables a position on the cassette to be freed for inclusion of an additional reagent vial. With the system of the invention a broader range of radiochemical syntheses can be envisaged using the cassette.

Abstract: Methods, systems, and apparatus to monitor component status in a bioprocessing environment are disclosed and described. Certain examples provide a sensor device for a disposable bioprocessing component. The example sensor device includes a first portion affixed to the component, the first portion configured to provide an identifier associated with the component. The example sensor device also includes a second portion configured to provide a status indication based on a state of the component. The example sensor device is configured to transmit the identifier and status indication to a control computer associated with a bioprocessing platform including the component.

Abstract: A fluid transfer assembly for single use bioreactors includes a fluid transfer housing that can be mounted to the impeller shaft using a bearing that places the fluid transfer assembly directly below the lowest impeller but allows the impeller shaft to spin inside independently of the fluid transfer assembly. A fluid conduit connects the fluid transfer housing to a port in the single use bag wall which allows fluids to be introduced into the sparger and which also helps prevent the fluid transfer assembly from rotating with the impeller shaft.

Abstract: A method for packing a media bed in a column (3). According to the invention the method comprises the steps of: providing data to a control unit (15) connected to the column (3), said data comprising at least a measured slurry concentration, a target bed height, a target packing factor or compression factor and minimum and maximum acceptable values for at least one of target bed height and target packing or compression factor; forcing a movable adapter (9) along a longitudinal axis of the column (3) in order to pack the media; detecting when the media bed is consolidated; the control unit (15) processing the provided data and the information about the consolidated bed height in order to present to the user acceptable bed heights, if there are any, giving acceptable packing or compression factors.

Abstract: The invention relates to a separation matrix comprising at least 11 mg/ml Fc-binding ligands covalently coupled to a porous support, wherein: a) the ligands comprise multimers of alkali-stabilized Protein A domains, and b) the porous support comprises cross-linked polymer particles having a volume-weighted median diameter (d50,v) of 56-70 micrometers and a dry solids weight of 55-80 mg/ml.

Abstract: An Fc-binding polypeptide of improved alkali stability, comprising a mutant of an Fc-binding domain of Staphylococcus Protein A (SpA), as defined by SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO:3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:22, SEQ ID NO 51 or SEQ ID NO 52 wherein at least the asparagine or serine residue at the position corresponding to position 11 in SEQ ID NO:4-7 has been mutated to an amino acid selected from the group consisting of glutamic acid, lysine, tyrosine, threonine, phenylalanine, leucine, isoleucine, tryptophan, methionine, valine, alanine, histidine and arginine.

Abstract: The present invention relates to a method for storage and subsequent lysis of a sample in which the sample is immobilized on a solid support. The solid matrix is embedded with a low concentration of both a chaotropic salt and a surfactant which act synergistically to efficiently store and lyse a biological sample.

Abstract: Methods, apparatus, systems and articles of manufacture are disclosed herein to implement flexible bioreactor control systems. An example apparatus disclosed herein includes a processor coupled to a memory, the processor programmed to determine whether the map value included in the process task object is a valid map value, the process task object to correspond to a task executed by a bioreactor, a control device or a measurement device of the bioreactor control system configuration, in response to determining the map value is a valid map value, decode the map value to identify the source location of a first input of the process task object, pull a value from the source location to update the input value of the process task object, and facilitate execution of the process task with the input value.

Abstract: A bioreactor system includes a vessel having a bottom floor, a flexible bioprocessing bag disposed within the vessel, and a flexible bladder positioned intermediate the bottom floor of the vessel and the bioprocessing bag. The flexible bladder is selectively inflatable to vary at least one of a geometry or configuration of the bioprocessing bag to provide for improved drainability or an increased turndown ratio for the bioreactor system.

Abstract: A method for regulating parameters of at least two bioreactor bags individually, which bioreactor bags are provided on one and the same rocking part of a bioreactor system. The method includes the steps of: determining an individual weight of the content in each bioreactor bag at different points in time during processing; regulating one or more parameters in each bioreactor bag in dependence of the individual weights.

Abstract: The present invention is within the field of chromatography. More precisely, it relates to a novel chromatography medium, namely a hydrophobic medium provided with different lids excluding molecules over a certain size due to the porosity of the hydrophobic medium and/or the porosity of the lid. The invention also relates to use of the separation medium for purification of large molecules, which do not enter the separation medium, as well as small molecules, which enter the separation medium and are eluted from there.