Fenwal, Inc.

Alaina Schlinker

Christopher J Wegener

Bret M Olson

Steven C Binninger

Avnie A Kadakia

Kyle Wolok

Melanie Hamilton

Kyle Thompson

Tanima Jahan Abedin

Steven Binninger

Jacintha Sales

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.

Systems and methods for processing large volumes of biological fluid

A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.

Cell processing methods with process parameter control

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

System and method for selecting and culturing cells

A method is provided for removing red blood cells from a suspension comprising red blood cells, white blood cells, platelets and plasma using a spinning membrane separator. The method comprises: a) flowing whole blood into the gap of the spinning membrane separator; b) collecting red blood cells and white blood cells in the gap and passing plasma and platelets through the membrane; c) introducing a first quantity of lysing buffer into the gap; d) incubating the red blood cells, white blood cells and lysing buffer in the gap for a period of time to cause a lysis reaction with the red blood cells; e) introducing a second quantity of lysing buffer into the gap to displace the first quantity of lysing buffer and a first quantity of red blood cell debris out of the gap; f) introducing a first quantity of wash buffer into the gap to quench the lysis reaction and displace the second quantity of lysing buffer and a second quantity of red blood cell debris out of the gap; and g) introducing a second quantity of wash buffer into the gap to flow washed white blood cells out of the housing.

System and method to lyse and remove red blood cells from a cell product

Methods and systems for priming a disposable fluid circuit for the processing of a biological fluid are disclosed. The methods and systems allow for variable and configurable priming of the flow path(s) leading to one or more biological fluid source containers.

Systems and methods for priming a fluid circuit

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.

Cell washing system with process parameter control

A cell washing system includes a fluid circuit, a source container, a source of wash solution, a pump, and a separator device. The system also includes a touch screen configured to receive user input and to display data to a user, and a controller coupled to the touch screen and configured to control the separator device and pump to operate a wash procedure, wherein the controller is configured to receive from the touch screen user input data for at least one protocol, the at least one protocol including values for a set of process parameters for a wash procedure, to store the at least one protocol in a memory, to receive an identifier associated with a user, to apply the at least one protocol based at least in part on the identifier, and to operate the wash procedure using the applied protocol.

Cell processing system and method with process parameter control

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.

Cell processing system and method with centralized data management, monitoring and/or control

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.

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. The apparatus and disposable sterile circuit are configured to remove platelets from the cellular product to form a platelet-depleted cellular product, resuspend the platelet-depleted cellular product in media to form a resuspended platelet-depleted cellular product, receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product, incubate the agent with the target substrate cells over a period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells, and remove unbound/unassociated agent to form a second mixture comprising the agent-target substrate cell complexes and non-target substrate cells.

System and method for processing, incubating, and/or selecting biological cells

A cell processing system includes a processor connectable to a source container filled with a biological fluid and one or more wash media containers. The processor includes a separator connectable to the source container and a product container, the separator configured to separate the biological fluid from the source container into at least two streams. In addition, a controller is coupled to the processor and configured to: cause the separator to separate the biological fluid into at least two streams, direct one of the at least two streams into the product container, subsequently pause processing of the biological fluid, after pausing, determine a measured cell count in the product container, and add fluid to the product container from the wash media containers as a function of the measured cell count in the product container while the product container is connected to the wash media containers.

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Chicago, IL, United States of America

Alaina Schlinker