Fenwal, Inc.

Steven C Binninger

Christopher J Wegener

Bret M Olson

Alaina Schlinker

Daniel R Boggs

James D Hosek

Avnie A Kadakia

Kyle Thompson

Kyle Wolok

Melanie Hamilton

Divya Patil Hangargekar

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.

Cell processing system and method with preliminary process evaluation

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 variety of fill options is provided for a cell processing system. Certain options relate to a syringe assembly that receives a product directly from a separator. Other 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 receive product from a product container associated with the cell processing system.

Cell processing system and method with fill options

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

Biomedical containers for sampling and mixing biological fluids are disclosed. The biomedical containers are at least substantially spherical and include access sites for accessing the container interior. The containers may be included as part of a disposable biological fluid processing kit.

Spherical biomedical sampling and mixing container

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

Devices and methods are provided for sterile transfer of flowable material between a syringe and one or more flowable material receptacles or between a pair of receptacles. A syringe assembly may include a tip enclosure having a flexible shroud surrounding a syringe tip, with a shroud membrane associated with the distal end of the shroud to enclose the syringe tip. The shroud is deformable to move the tip toward the shroud membrane, which may be traversed by the tip to expose the tip for material transfers. A rigid connector may be positioned at the distal end of the shroud to securely connect the syringe assembly to a receptacle. The plunger and piston of the syringe assembly may include membranes to allow material transfer at the proximal end of the syringe assembly. An adaptor may also be provided for sterilely connecting a receptacle to a syringe or to another receptacle.

Growing community of inventors

Evanston, IL, United States of America

Steven C Binninger