Abstract: A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product.

Abstract: Automated systems and methods for processing a biological cell suspension are disclosed. The systems and methods allow for the processing of large volumes of a biological cell suspension contained in or more source containers.

Abstract: An irradiation device for photopheresis, comprising an exposure chamber configured to receive an illumination container holding a target cell suspension; an irradiation source configured to irradiate the illumination container and target cell suspension for a certain exposure time period; an irradiation sensor configured to detect the intensity of irradiation emitted by the irradiation source; and a processing circuit coupled to the irradiation sensor and configured to treat the target cell suspension with a predetermined treatment dosage of radiation, wherein the processing circuit adjusts the exposure time period based on the intensity of irradiation in order to achieve the predetermined treatment dosage.

Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: An irradiation device for photopheresis, comprising an exposure chamber configured to receive an illumination container holding a target cell suspension, an irradiation transmitter configured to irradiate the illumination container and target cell suspension, an irradiation receiver configured to detect absorption of radiation from the irradiation transmitter, and a processing circuit coupled to the irradiation receiver and configured to determine whether a hematocrit of the target cell suspension exceeds a predetermined threshold hematocrit and to treat the target cell suspension with a treatment dosage of radiation if the predetermined threshold is exceeded.

Abstract: A system for washing red blood cells, comprising a separator configured to separate a quantity of blood into concentrated red blood cells having a hematocrit of at least 60% and a volume of 150-250 mL, and a supernatant component. The system comprises a flow controller configured to remove the supernatant component to provide an initial red blood cell concentrate; combine 50-500 mL of an additive solution with the red blood cell concentrate to provide an intermediate red blood cell product intended for storage for 42 days or less, wherein the intermediate red blood cell product at the end of storage has an osmolarity value between 202-479 mOsm/L; and wash the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L with a washing solution having an osmolarity value higher than that of the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L.

Abstract: A cell processing system includes a first processor connectable to a source container filled with a biological fluid, a second processor, and a controller coupled to the processors. The first processor includes a separator configured to separate the biological fluid into at least two streams of material, and a first container configured to receive one of the streams. The second processor includes a magnetic separator configured to select target cells, the target cells being associated with magnetic particles, a second, pass-through container associated with the magnetic separator, the second container connected at a first end to the first container, and a third container connected to a second end of the pass-through container. One of the processors includes at least one pump configured to transfer material between the separator and the first container, and between the first container and the second container.

Abstract: A device for pooling a blood component stored in source containers includes a pump or pumps configured to pump a fluid in a first direction and a second direction and receive a pump line having a first end connected to the source containers. A pool clamp is configured to receive a pool line having a first end connected to a second end of the pump line and a second end connected to a pool container. A wash clamp is configured to receive a wash line having a first end connected to the second end of the pump line and a second end connected to a wash media container. A controller is configured to open the pool clamp, close the wash clamp and operate the pump in the first direction and to alternatively close the pool clamp, open the wash clamp and operate the pump in the second direction.

Abstract: A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.

Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: A network of cell processing systems including a plurality of cell processing instruments and a server computer. Each cell processing instrument includes a control circuit configured to operate the cell processing instrument according to a modifiable process parameter, a component of the cell processing instrument and a sensor configured to measure a characteristic of the component. The server computer is disposed remotely from the cell processing instruments, and is configured to transmit a request message for a value measured by the sensor, receive a response message based on the request message, and generate a notification message based on the response message.

Abstract: A disposable fluid pump is provided with a housing including first and second faces, with a sidewall extending between the first and second faces. The housing defines a chamber, with an inlet and an outlet in fluid communication with the chamber. An impeller is rotatably mounted within the chamber and includes a plurality of flexible vanes. Such a pump may be incorporated into a disposable fluid flow circuit that is adapted to be mounted on a durable hardware for processing a fluid. In such a fluid flow circuit, the fluid pump may be integrated into a cassette of the circuit or, alternatively, the inlet and outlet of the fluid pump may be directly connected to fluid flow conduits of the circuit.

Abstract: A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.

Abstract: A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product.

Abstract: A cell processing system includes at least one processor connectable to a source container filled with a biological fluid, the at least one processor including a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet, one or more containers selectively connected to the first outlet; and, and a magnet. The system also includes a controller coupled to the at least one processor and configured to operate the spinning membrane to receive biological fluid from the source container and to direct the target cells to one of the one or more containers, to pause to permit magnetic particles to be associated with the target cells, and to operate the spinning membrane to receive the contents of one of the one or more containers with the magnet applied to the target cells associated with the magnetic particles.

Abstract: A cell processing system includes a processor to receive a biological fluid to be processed, a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter, and at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied. The controller is configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

Abstract: A device for connecting first and second medical fluid flow systems includes a linear movement carriage system that is positioned within a housing. The carriage system includes first and second connector holders configured to hold first and second connectors of the first and second medical fluid flow systems, respectively. A coupler holder is configured to hold a coupler and is positioned substantially between the first and second connector holders. The first and second connector holders and the coupler holder are relatively moveable between a separated configuration, where the first and second connectors and the coupler are located in relatively spaced apart positions, and a joined configuration, where the first and second connectors engage the coupler. An ultraviolet light source is positioned in the housing so as to irradiate first and second connectors and the coupler.

Abstract: A fluid circuit for cell washing is provided that comprises a spinning membrane separator and a fluid management system comprising a cassette that defines the fluid pathways, and including internally mechanical valving, pressure sensing and air sensing for controlling flow through the fluid pathways, thus minimizing the volume of the fluid circuit. Additionally, the fluid circuit comprises syringes that are acted on by syringe pumps associated with the hardware component of the system to provide pressure for moving fluid through the circuit. Preferably, the syringes are connected directly to the cassette, or formed integrally within the cassette housing, thus further minimizing the volume of the fluid circuit.

Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching.