Cell therapy protocol system and cell therapy method

Abstract

Disclosed are systems and methods for cell therapy treatment or training in a cell therapy suite. The suite is capable of receiving information including a library of cell therapy protocols for multiple combinations of multiple patient indications and multiple genes of interest (GOIs). The suite is capable of receiving a request to treat a patient with a cell therapy based on the combination of the patient indication and GOI, and responsive to receiving the request, performing steps of a respective cell therapy patient protocol from the library of cell therapy protocols that corresponds to the combination of the patient indication and GOI.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 306,711, filed February 4, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present application relates generally to systems and methods for delivering cell therapy to a patient, and more specifically to systems, methods and suites for providing, implementing and maintaining state-of-the-art operating conditions and protocols for cell therapy. [Background technology]

[0003] There are many challenges to bringing cell therapy to the mass market. First, unless the therapy is an indication with a large or near-universal market size, there is not enough potential business volume to build a single-indication cell therapy treatment system, which may reduce market size, especially if the therapy is approved for a subset of the initial targets. Second, the high level of specialization and specificity of each therapy, and the high level of skill required by engineers to plan, manage, and execute a commercial cell therapy deployment, inhibit the creation and use of a common platform. Finally, the fields of cell and gene therapy are still in their infancy, so even if a common platform were created (which would require a huge initial investment), it may be quickly superseded by ongoing developments in new technologies. Summary of the Invention [Problem to be solved by the invention]

[0004] To enable widespread use and adoption of cell therapy, it is desirable for the therapeutic system to be based on a platform with large market size, be usable as a common platform for multiple indications, be scalable in deployment and management, and be an adaptable platform that can incorporate new technologies while retaining original or existing features. Applicant has discovered systems and methods that can employ a suite to facilitate cell therapy for patients. Additionally, Applicant has discovered systems and methods for training technical personnel involved in the delivery of cell therapy to patients. Effect of the Invention

[0005] Each cell therapy is different; that is, current cell therapies may have different protocols, often tailored to allow for scalable production. For example, protocols for CAR-T cell therapy are optimized to send a patient's cells to a centralized location, process them, and send them back for infusion. However, the systems and methods disclosed herein can employ a local-only approach, avoiding some of the customization required for such workflows. In addition, because treatment and culture can be automated and software-based within the suite, new protocols and changes to protocols can be updated and "patched" in real time via a network connection. Such updates can also incorporate new knowledge, new technologies, and protocol optimizations, ensuring that cell therapies are kept up to date.

[0006] The suite disclosed herein can be a common platform for cell therapy that is compact, modular, standalone, and / or scalable with the flexibility to be applicable to virtually any cell therapy and do so quickly. Because the suite disclosed herein is compact, modular, and standalone, it can be deployed in a very small footprint in a hospital or clinic. Thus, a small Good Manufacturing Practice (GMP) suite can be installed in virtually any room with enough floor space (and external power in some cases). It can be installed in hard-to-reach locations, as long as the initial supply of drugs and consumables (such as tubing, sterile bags, and other plastic products) is sufficient. In addition, data collected by the entire system during cell therapy procedures in the suite can be used to improve or customize the therapy. Finally, the systems and methods (and suites) disclosed herein can lead to overall cost reductions in all cell therapies due to economies of scale and efficiencies gained from a local-only strategy. [Means for solving the problem]

[0007] In some embodiments, the cell therapy suite comprises one or more processors configured to receive information comprising a library of cell therapy protocols for a plurality of combinations of a patient indication and a gene of interest (GOI); receive a request to treat a patient with a cell therapy based on the combination of the patient indication and the GOI; and in response to receiving the request to treat the patient with a cell therapy, perform steps of a respective cell therapy patient protocol from the library of cell therapy protocols corresponding to the combination of the patient indication and the GOI. In some embodiments, the received information is from a remote server location external to the suite. In some embodiments, the suite comprises a cell processing device. In some embodiments, the information comprising the library of cell therapy protocols comprises a plurality of operating conditions of the cell processing device for a plurality of combinations of the patient indication and the GOI. In some embodiments, receiving the request to treat a patient with a cell therapy based on the combination of the patient indication and the GOI comprises receiving a request for operating conditions of the cell processing device based on the combination of the patient indication and the GOI. In some embodiments, in response to receiving the request for operating conditions, the one or more processors are configured to process the patient's cells having RNA carrying the GOI in the cell processing device according to the respective operating conditions corresponding to the combination of the patient indication and the GOI. In some embodiments, the RNA is c-srRNA. In some embodiments, the one or more processors are configured to receive a library of modifications of cell therapy protocols for multiple combinations of patient indications and GOIs. In some embodiments, the cell therapy suite is an ISO5, ISO7 or ISO8 clean room. In some embodiments, the suite comprises an RNA generation unit configured to load the GOI into an RNA vehicle.In some embodiments, the one or more processors are configured to receive a patient's GOI identified by the sequencer, and in response to receiving the patient's identified GOI, load the identified GOI into an RNA vehicle in the RNA generation unit, or the one or more processors are configured to transmit the identified GOI information to a remote server location outside the suite. In some embodiments, the suite includes a sequencer for identifying the patient's GOI. In some embodiments, the suite includes an apheresis device for extracting the patient's cells.

[0008] In some embodiments, a system for cell therapy treatment comprises a cell therapy suite; one or more processors configured to receive information including a library of cell therapy protocols for multiple combinations of patient indications and genes of interest (GOIs); receive a request to treat a patient with a cell therapy based on the combination of the patient indication and GOI; and in response to receiving the request to treat the patient with a cell therapy, perform steps of a respective cell therapy patient protocol from the library of cell therapy protocols that corresponds to the combination of the patient indication and GOI.

[0009] In some embodiments, a method is performed in a system including a cell therapy suite and one or more processors, the method including receiving information including a library of cell therapy protocols for multiple combinations of patient indications and genes of interest (GOIs), receiving a request to treat a patient with a cell therapy based on the combination of the patient indication and GOI, and in response to receiving the request to treat the patient with a cell therapy, performing steps of a respective cell therapy patient protocol from the library of cell therapy protocols that corresponds to the combination of the patient indication and GOI.

[0010] In some embodiments, a non-transitory computer readable medium storing cell therapy instructions, the instructions configured to be executed by one or more processors of a system comprising a cell therapy suite, the instructions configured to cause the system to receive information including a library of cell therapy protocols for a plurality of combinations of patient indications and genes of interest (GOIs); receive a request to treat a patient with a cell therapy based on the combination of the patient indication and the GOI; and in response to receiving the request to treat the patient with a cell therapy, perform steps of a respective cell therapy patient protocol from the library of cell therapy protocols corresponding to the combination of the patient indication and the GOI.

[0011] In some embodiments, a cell therapy treatment system comprises one or more processors configured to receive a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); in response to receiving the cell therapy protocol, display instructions on how to perform a first step of the cell therapy protocol; determine whether the steps of the cell therapy protocol are complete; and in response to determining whether the steps of the cell therapy protocol are complete, display instructions on how to perform a second step of the cell therapy protocol. In some embodiments, the system comprises a heads-up display (HUD), and the instructions on how to perform the first step of the cell therapy protocol are displayed on the HUD. In some embodiments, the HUD is an augmented reality HUD, and the instructions on how to perform the first step of the cell therapy protocol are overlaid on components of the cell therapy suite. In some embodiments, the instructions on how to perform the first step of the cell therapy protocol identify components of the cell therapy suite used in the step of the cell therapy protocol. In some embodiments, the HUD is a virtual reality HUD, and the instructions on how to perform the first step of the cell therapy protocol comprise a simulated cell therapy suite. In some embodiments, the HUD comprises an image capture device, and in response to receiving the cell therapy protocol, the image capture device captures an image of the cell therapy suite. In some embodiments, determining whether the first step of the cell therapy protocol is completed includes receiving a user input indicating that the step of the cell therapy protocol is completed. In some embodiments, determining whether the first step of the cell therapy protocol is completed includes determining whether a user performs a gesture corresponding to the first step of the cell therapy protocol. In some embodiments, in response to receiving the cell therapy protocol, an audio indication of how to perform the first step of the cell therapy protocol is provided. In some embodiments, in response to determining whether the step of the cell therapy protocol is completed, an audio or tactile feedback is provided.

[0012] In some embodiments, a method of cell therapy performed on a system including one or more processors comprises receiving information including a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); in response to receiving the cell therapy protocol, displaying instructions on how to perform a first step of the cell therapy protocol; determining whether the steps of the cell therapy protocol are complete; and in response to determining whether the steps of the cell therapy protocol are complete, displaying instructions on how to perform a second step of the cell therapy protocol.

[0013] In some embodiments, a non-transitory computer readable medium storing cell therapy instructions comprises instructions configured to be executed by one or more processors, where execution of the instructions is configured to cause the system to receive a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); in response to receiving the cell therapy protocol, display instructions on how to perform a first step of the cell therapy protocol; determine whether the steps of the cell therapy protocol are complete; and in response to determining whether the steps of the cell therapy protocol are complete, display instructions on how to perform a second step of the cell therapy protocol.

[0014] In some embodiments, a system for cell therapy treatment comprises a cell therapy suite; one or more processors configured to receive a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); capture an image of the cell therapy suite and / or the patient in response to receiving the cell therapy protocol; transmit the image of the cell therapy suite and / or the patient from the cell therapy suite to a remote location, and receive instructions on how to perform the steps of the cell therapy protocol in response to transmitting the image of the cell therapy suite. In some embodiments, the instructions on how to perform the steps of the cell therapy protocol are from a location outside the cell therapy suite. In some embodiments, the instructions on how to perform the steps of the cell therapy protocol are from a remote operator viewing the image of the cell therapy suite and / or the patient at a location outside the cell therapy suite. In some embodiments, the image of the cell therapy suite includes an image of a component identifier of a component of the cell therapy suite, and the instructions on how to perform the steps of the cell therapy protocol include instructions on how to operate the component of the cell therapy suite. In some embodiments, the component identifier is a QR code or a barcode corresponding to the component of the cell therapy suite. In some embodiments, the image of the cell therapy suite and / or patient is a video image of the cell therapy suite. In some embodiments, the one or more processors are configured to, in response to receiving the instructions on how to perform the steps of the cell therapy protocol, display the instructions on how to perform the steps of the cell therapy protocol. In some embodiments, the system includes a heads-up display (HUD), and the instructions on how to perform the first step of the cell therapy protocol are displayed on the HUD. In some embodiments, the HUD is an augmented reality HUD, and the instructions on how to perform the steps of the cell therapy protocol are overlaid on components of the cell therapy suite.

[0015] In some embodiments, a method of cell therapy performed in a system comprising a cell therapy suite and one or more processors includes receiving a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); capturing an image of the cell therapy suite and / or the patient in response to receiving the cell therapy protocol; transmitting the image of the cell therapy suite and / or the patient from the cell therapy suite to a remote location; and receiving instructions on how to perform the steps of the cell therapy protocol in response to transmitting the image of the cell therapy suite.

[0016] A non-transitory computer readable medium storing cell therapy instructions, the instructions configured to be executed by one or more processors of a system having a cell therapy suite, where execution of the instructions configures the system to: receive a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI); in response to receiving the cell therapy protocol, capture images of the cell therapy suite and / or the patient; transmit the images of the cell therapy suite and / or the patient from the cell therapy suite to a remote location; and in response to transmitting the images of the cell therapy suite, receive instructions on how to perform the steps of the cell therapy protocol.

[0017] In some embodiments, any one or more of the features of any one or more of the systems, methods, suites, and / or computer-readable storage media described above can be combined, in whole or in part, with each other and / or with other features or features described elsewhere herein.

[0018] Exemplary embodiments will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a schematic diagram of a system for cell therapy guidance, according to some embodiments.

[0020] [Diagram 2] FIG. 2 is a flow chart illustrating a method of providing cell therapy guidance, according to some embodiments.

[0021] [Diagram 3] FIG. 3 is a second flowchart illustrating a method for providing cell therapy guidance, according to some embodiments.

[0022] [Figure 4] FIG. 4 is a diagram illustrating an example of an augmented reality or virtual reality HUD according to some embodiments.

[0023] [Diagram 5] FIG. 5 is a diagram illustrating a computer according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Reference will now be made in detail to implementations and embodiments of the various aspects and variations of the systems and methods described herein. Although several exemplary variations of the systems and methods have been described herein, other variations of the systems and methods may include aspects of the systems and methods described herein combined in any suitable manner having a combination of all or a portion of the described aspects.

[0025] Disclosed herein are systems, methods, computer readable media, and techniques that may address one or more of the above-mentioned needs. Described herein are exemplary embodiments of a system for providing cell therapy in a suite that may address the problems and shortcomings of the known systems and methods described above.

[0026] FIG. 1 illustrates a system 100 for communicating information (e.g., data, commands, etc.) between a cell therapy provider system 101 and a cell therapy suite 102, according to some embodiments. As illustrated, the system 100 may include a cell therapy suite or multiple cell therapy suites where cell therapy procedures may be performed on a patient. In some embodiments, the system may not include a cell therapy suite. The suite may be a suite used in a hospital or other medical facility to treat patients with cell therapy. In some embodiments, the suite may be a standalone suite for treating patients with cell therapy, independent of a hospital or other medical facility. For example, it may be a modular, standalone mini-clinic for cell therapy. In some embodiments, the cell therapy suite may be located in any facility as a standalone suite for providing cell therapy services. For example, the cell therapy suite may be located in a pharmacy or may be built as a mobile unit that can visit hospitals and other medical facilities as needed for cell therapy services. Such a suite may be a clean room that meets ISO5, ISO7, and / or ISO8.

[0027] Some or each of the components in FIG. 1 may be communicatively coupled to one another to send and receive electronic information via network communications with one another. As shown in the example of FIG. 1, a cell therapy provider system 101 may be communicatively coupled to a cell therapy suite 102. Information may be transmitted from the cell therapy provider system 101 to the cell therapy suite 102 and vice versa to provide components within and outside the cell therapy suite (e.g., cell processing devices, computers, displays, apheresis devices, sequencers, RNA generation units, etc.) with up-to-date information (i.e., instructions, protocols, settings, data, etc.) for performing or training a cell therapy for a patient for a given session / day. In some embodiments, the cell therapy provider system may also send information (e.g., maintenance / update pings, commands, etc.) to any and all components within and outside the suite (refrigerators, freezers, incubators, apheresis devices, etc.). In some embodiments, the cell therapy provider may push updates of electronic information sent from the cell therapy provider system to components within and outside the cell therapy suite. This is done automatically or manually by cell therapy provider personnel or a remote operator 120 (e.g., a supervisor of operators in or outside the suite or a supervisory system). In some embodiments, the cell therapy provider system can include a remote operator 120 (e.g., a supervisor of operators in or outside the suite). In some embodiments, the remote operator can be at a location outside the suite or remote from the suite and / or operator. In some embodiments, the remote operator can be part of a separate system 120 that is communicatively coupled to the cell therapy provider system and / or the cell therapy suite 102.Information may be transferred from the remote operator 120 to the cell therapy provider system 101 and / or cell therapy suite 102, or vice versa, to provide components located within or outside the suite (e.g., cell processing devices, computers, displays, apheresis devices, sequencers, RNA generation units, etc.) with up-to-date information (i.e., instructions, protocols, settings, data, etc.) for performing or training a cell therapy within or outside the suite for a given session / day. In some embodiments, the remote operator may also send information (e.g., maintenance / update pings, commands, etc.) to any and all components (refrigerator(s), freezer(s), incubator(s), apheresis devices, etc.) through the cell therapy provider system and / or through the remote operator itself within or outside the suite. In some embodiments, the remote operator may push updates to the electronic information sent to components within or outside the cell therapy suite through the cell therapy provider system and / or through the remote operator itself.

[0028] In some embodiments, some or each of the components of FIG. 1 may be communicatively coupled to one another such that they can send and receive electronic information to one another via network communications without the need for a cell therapy suite. For example, the cell therapy provider system 101 (and / or remote operator) may be communicatively coupled to computer(s) or other components outside of the cell therapy suite. Information may be transferred from the cell therapy provider system 101 (and / or remote operator) to such computer(s) or other components to provide the components outside of the suite with up-to-date information (i.e., instructions, protocols, settings, data, etc.) for administering cell therapy to a patient, and vice versa. In some embodiments, the cell therapy provider system (and / or remote operator) may also send information (e.g., maintenance / update pings, commands, etc.) to any and all components outside of the suite. In some embodiments, the cell therapy provider (and / or remote operator) may push updates to electronic information sent from the cell therapy provider system (and / or remote operator) to the component(s) outside of the cell therapy suite. This may be done automatically or manually by cell therapy provider personnel.

[0029] In some embodiments, the cell therapy suite may include at least one of a number of other components, such as a cell processing device 103, an apheresis device 104, a computer 105, a refrigerator 106, a freezer 107, an incubator 108, a sequencer 109, an RNA generation unit 110, a biosafety hood 111, a display 118, an imaging device 119, a storage rack 112, etc. In some embodiments, any and all of these components may be outside the suite. Any and all of the components in the suite may be communicatively coupled to each other such that they may send and receive electronic information via network communications with each other. In some embodiments, only a portion of the components in the suite may be communicatively coupled to each other such that they may send and receive electronic information via network communications with each other. For example, the following information may be communicated between various components within and outside the suite: patient-specific associated data; suite environmental data; technician training information and materials; timing data; and / or "where in the procedure" data is shared between components or distributed by a computer in the suite to synchronize components of the patient's treatment. Additionally, treatments can be staggered (one patient's cells are in an incubator while another patient is being treated in another device, such as a cell processing or apheresis device), so that procedure and patient data can also be tracked and organized between the various components in the suite. Any and all such information can be put into a library of cell therapy protocols. These cell therapy protocols can be for multiple combinations of patient indications and genes of interest (GOIs). In some embodiments, the library can include at least one cell therapy protocol. In some embodiments, the cell therapy protocol can be for at least one combination of patient indication(s) and GOI(s). In some embodiments, the GOI can correspond to cell therapy protocols for one or more patient indications. In some embodiments, a cell therapy protocol for a given patient indication can correspond to one or more GOIs.In some embodiments, any and all components within or outside the suite can have a display, such as a graphical user interface, for displaying any information received by or transmitted from the component, in some embodiments, an operator within or outside the suite can interact with any of these displays, such as by touch if it is a touch screen.

[0030] In some embodiments, any and all components may be external to the suite and communicatively coupled to each other to send and receive electronic information via network communications. In some embodiments, only a portion of the components outside the suite may be communicatively coupled to each other to send and receive electronic information via network communications. For example, the following information may be communicated between the various components outside the suite: patient specific associated data; suite environmental data; technician training information and materials; timing data; and / or "where in the procedure" data is shared between components or distributed by a computer within the suite to synchronize components of the patient's treatment. In addition, since treatments can be staggered (one patient's cells are in the incubator while another patient is being treated on another device, such as a cell processing device or apheresis device), tracking and organization of procedure and patient data can also be communicated between the various components outside the suite. Any and all such information can be put into a library of cell therapy protocols. These cell therapy protocols can be for multiple combinations of patient indications and genes of interest (GOI). In some embodiments, any and all components outside the suite can have a display, such as a graphical user interface, for displaying any information received by or transmitted from the component, and in some embodiments, an operator or technician outside the suite can interact with any of these displays, such as by touch if it is a touch screen.

[0031] In some embodiments, any and all components within and outside the suite may be communicatively coupled to the cell therapy provider system 101 (and / or remote operator) to send and receive electronic information via network communications with each other. In some embodiments, only a portion of the components within and outside the suite are communicatively coupled to the cell therapy provider system 101 (and / or remote operator) to send and receive electronic information via network communications with each other. For example, a computer within or outside the suite may be communicatively coupled to the cell therapy provider system (and / or remote operator) and communicatively coupled to other components within and outside the suite, such as cell processing devices, such that only the computer can communicate with the cell therapy provider system (and / or remote operator) and communicate with other components within and outside the suite. In this manner, other components within and outside the suite may communicate with the cell therapy provider system (and / or remote operator) via the computer. Any and all components within and outside the cell therapy suite may include one or more computer processors configured to send and receive electronic information.

[0032] In some embodiments, any and all components within and outside the suite may forward the following information to the cell therapy provider system (and / or remote operator): information used for learning and analysis (such as machine learning or artificial intelligence); information to assist and / or guide the operator or technician (e.g., real-time assistance); information used to train or monitor the operator or technician; offloaded data processing, live streamed data, or programs to operate the suite (including "where in the procedure," any errors, live data, or data about the patient sent from a computer in the suite room); maintenance or update pings or commands for networked equipment such as refrigerators, incubators, apheresis machines, patient data based on appointment times / confirmations, augmented reality training programs / running programs; validation keys for subscriptions; network timing protocol information; and information regarding shipping, consumables, and timing based on usage in the suite.

[0033] 2 shows a flow chart depicting an exemplary method 200 of providing cell therapy guidance, according to some embodiments. As described in more detail below, method 200 can enable a system (such as system 100) to receive information including a library of cell therapy protocols for a plurality of combinations of a patient indication and a gene of interest (GOI), peptide, or small molecule; receive a request to treat a patient with a cell therapy based on the combination of the patient indication and the GOI, peptide, or small molecule, and / or receive a request to train an operator based on the combination of the patient indication and the GOI, peptide, or small molecule; and, in response to receiving the request to treat the patient with a cell therapy, perform steps of a respective cell therapy patient protocol corresponding to the combination of the patient indication and the GOI, peptide, or small molecule from the library of cell therapy protocols.

[0034] In some embodiments, method 200 may be performed, in whole or in part, by one or more of the components of a system, such as system 100, described in Figure 1 and the corresponding description. In some embodiments, any one or more of the aspects of method 200 may be combined, in whole or in part, with any one or more of the components of Figure 1, and / or any one or more of the systems, methods, devices, and / or techniques described elsewhere herein.

[0035] At block 201, in some embodiments, the system may receive information including a library (or a portion thereof) of cell therapy protocols for multiple combinations of patient indications and genes of interest (GOIs), peptides, or small molecules. In some embodiments, the library of cell therapy protocols may include at least one combination of patient indications and GOIs, peptides, or small molecules. In some embodiments, the library of cell therapy protocols may be a single cell therapy protocol for a particular combination of patient indications and GOIs, peptides, or small molecules. In some embodiments, the library of cell therapy protocols may include at least a portion or step of a cell therapy protocol, or an update to at least a portion / step of a cell therapy protocol. For example, when the library of cell protocols is updated, one or more cell protocols (or steps thereof) are transmitted / received to update the library. In other words, the entire library does not always need to be transmitted / received. Instead, only a portion of it may be transmitted / received. In some embodiments, the cell therapy protocol may be a training cell therapy protocol used to teach an operator how to perform cell therapy on a patient. In this manner, the cell therapy protocol may be a training version of an actual cell therapy protocol. For example, a cell therapy protocol may not include all steps of an actual cell therapy patient protocol because the patient may not be present when an operator is training to use the cell therapy suite:

[0036] In some embodiments, the cell therapy provider system can transmit information to any and all separate components within and outside the suite regarding the following as further detailed herein: cell processing device protocols; maintenance or update pings or commands for network connected devices such as refrigerators, incubators and / or apheresis machines; patient data based on appointment times / verification; training programs (e.g., augmented or virtual reality training / execution programs); real-time assistance / guidance including real-time record keeping (e.g., video recordings, barcode (QR) scanning, digitized checklists) subscription verification keys; network timing protocol information; plasmid DNA sequences and RNA sequences for production; information to regulate smart UPS power usage; shipment, consumables, and timing information based on suite usage, which may be tracked by weight changes in storage racks, scanning of barcodes by cell processing devices or using embedded computers, or cameras or other sensors that detect reagent or material usage. Any and all such information can be included in the library of cell therapy protocols. Any and all such information may be stored on a computer within or outside the suite, in memory of individual components within or outside the suite, or in the cell therapy provider system (and / or at a remote operator).

[0037] In some embodiments, cell therapy provider system 101 and remote operator 120 may be devices or systems including one or more computer processors configured to transmit and receive electronic information. In some embodiments, all or a portion of cell therapy provider system 101 and remote operator 120 may be provided as a desktop computing device, laptop, tablet, mobile electronic device, computing module, processor, server, cloud computing system, distributed computing system, etc. In some embodiments, cell therapy provider system 101 and remote operator 120 may be provided locally with respect to cell therapy suite 102 (e.g., within the suite), while in some embodiments, cell therapy provider system 101 and remote operator 120 may be provided remotely from suite 102 (e.g., outside the suite, at a remote server location, etc.).

[0038] In the example system 100, at least one of the components within or outside of suite 102 can be configured to communicate (e.g., by any suitable wired or wireless network communication protocol) with cell therapy provider system 101 (and / or a remote operator). In some embodiments, components within or outside suite 102 can be configured to communicate (e.g., by any suitable wired or wireless network communication protocol) with any or all other components within or outside suite 102. In some embodiments, components other than computer 105 within or outside suite 102 can be configured to communicate only with computer 105. In some embodiments, only computer 103 (which may be outside the suite) can be configured to communicate with cell therapy provider system 101 (and / or a remote operator). In some embodiments, components within or outside suite 102 can be configured to send or receive information directly to or from one or more other components within or outside suite 102 and / or to or from cell therapy provider system 101 (and / or a remote operator). In some embodiments, any or all components within or outside suite 102 can be communicatively coupled to receive or transmit information to any or all components within or outside another suite 102. Communicatively coupled may mean that components are capable of communicating by any wired or wireless electronic communications medium, including any suitable network communications protocol.

[0039] As explained above, the system can include an apheresis device 104 for extracting human cells (e.g., blood cells). The apheresis device can be a conventional apheresis device, such as Terumo Spectra Optia. In some embodiments, the apheresis device can be a computer-controlled and / or automated apheresis device for extracting patient cells. For example, the apheresis device can collect the patient's blood, separate some of the blood components, and / or package these components into blood bags or similar bags for use in the next component of the cell therapy suite. In this manner, the patient can go to the cell therapy suite disclosed herein to collect blood cells using the apheresis device. In some embodiments, the patient's apheresis can be performed in another suite or a remote location outside the suite and brought to the suite for cell processing.

[0040] As described, the suite or off-suite location can include one or more processors configured to receive and transmit electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information, including the library of cell therapy protocols, can include maintenance / update pings and commands to the apheresis device. For example, the apheresis device can receive apheresis procedure information regarding which treatment a patient is undergoing and / or settings for performing apheresis on a particular patient. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to transmit electronic information (e.g., a library of cell therapy protocols) to the apheresis device itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can transmit apheresis procedure information for the apheresis device to a computer in or outside the suite. The computer can then communicate this information to the apheresis device or the computer can store this information and thereby control a cell processing device. The cell therapy provider system (and / or remote operator) can update and / or maintain this information on the apheresis device. For example, using a network connection, the cell therapy provider can push updates to apheresis settings from the cell therapy provider system (and / or remote operator) to a computer in or outside the cell therapy suite (which can then send the information to the apheresis device) and / or to the apheresis device. This can be done automatically or manually by cell therapy provider personnel. Cell therapy system personnel may include physicians, nurses, technicians, etc., or their supervisors, or individuals who know how to perform cell therapy protocols, are trained in performing cell therapy protocols, or are employed by the cell therapy provider. In some embodiments, cell therapy system personnel may include individuals unrelated to the cell therapy provider. In some embodiments, the remote operator can be considered cell therapy provider personnel.

[0041] At block 202, in some embodiments, the system can receive a request to treat a patient with a cell therapy based on a combination of the patient's indication and a GOI, peptide, or small molecule, and / or the system can receive a request to train an operator of the cell therapy system. At block 203, in some embodiments, the system can execute steps of a respective cell therapy patient protocol from a library of cell therapy protocols corresponding to the combination of the patient's indication and a GOI, peptide, or small molecule in response to receiving the request to treat a patient with a cell therapy and / or the request to train an operator of the cell therapy system. For example, in response to receiving the apheresis procedure information and / or in response to receiving a request from an operator, the apheresis device can execute an apheresis procedure, such as extracting the patient's blood cells (from a library of cell therapy protocols).

[0042] After apheresis, an operator can load the patient's blood cells and vectors (such as adeno-associated virus, DNA plasmids, RNA, self-replicating or self-amplifying RNA, or c-srRNA) expressing a GOI, peptide, or small molecule to treat an indication into a cell processing device in the suite. The cell processing device can be a computer-controlled and / or automated cell processing device for processing the patient's cells (e.g., human cells). In an embodiment, the cell processing device can be a CliniMACS® Prodigy device. Examples and descriptions of such cell processing devices can be found in U.S. Pat. Nos. 10,828,333; 10,350,245; 10,705,091; 10,705,090; 10,620,212; 10,131,876; 10,119,970; 10,072,245; 9,714,945; 9,625,463; and 9,493,789, all of which are incorporated by reference in their entireties.

[0043] In some embodiments, the electronic information and / or library of cell therapy protocols can include at least one or more operating conditions of the cell treatment device for multiple combinations of multiple patient indications and multiple genes of interest (GOIs), peptides, or small molecules. The multiple operating conditions can be a library of operating conditions or protocols of the cell treatment device based on a particular indication and multiple GOIs, peptides, or small molecules. As described above, a patient indication can correspond to one or more GOIs, peptides, or small molecules in a given cell therapy protocol, and vice versa. For example, a cell therapy protocol for an indication may require the utilization of multiple GOIs, peptides, small molecules. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to transmit the electronic information (i.e., the library of cell therapy protocols including multiple operating conditions of the cell treatment device) to any component(s) of the system within or outside the suite. The cell therapy provider system (and / or remote operator) can update and / or maintain this library of cell therapy protocols (e.g., operating conditions of the cell treatment device). For example, using a network connection, a cell therapy provider can push updates to a library of cell therapy protocols (e.g., operating conditions from a cell therapy provider system) to computers and / or cell processing devices within or outside the cell therapy suite. This can be done automatically or manually by cell therapy provider personnel. In some embodiments, updates are made to modify operating conditions for existing combinations of GOIs, peptides, or small molecules and indications, or to add operating conditions for new combinations of GOIs, peptides, or small molecules and indications.

[0044] In some embodiments, when the cell therapy suite is installed, a library of cell therapy protocols (e.g., a plurality of operating conditions for the cell processing device) may also be installed on the cell processing device and / or computer, which may include all known operating conditions for cell therapies that are being developed or approved at the time of installation. However, upon development and approval of new cell therapies, or updates to existing cell therapies, operating conditions for the cell processing device when handling such new cell therapies may be created and added to the library of existing operating conditions. In some embodiments, the cell therapy provider system (and / or remote operator) may transmit these new operating conditions for the cell processing device. Furthermore, if the operating conditions of an existing combination of a GOI, peptide, or small molecule and an indication are changed to improve the corresponding cell therapy, the existing operating conditions of such GOI, peptide, small molecule, and indication combination may be replaced with the operating conditions of the improved therapy. In some embodiments, the cell therapy provider system (and / or remote operator) may transmit these new operating conditions for the cell processing device. In some embodiments, updating the library may be done in any conventional manner. For example, a technician can update the library of cell therapy protocols in the computer and / or cell processing device either within or outside the suite, or remotely from another computer (i.e., a remote operator and / or cell therapy provider system) connected to the suite by manually loading the update into the library and pushing it to the suite. In some embodiments, the computer and / or cell-cell processing device can be connected over a network to a server computer (i.e., a cell therapy provider system and / or a remote operator) that is located at a remote location away from where the suite is located. Under this configuration, the server computer can automatically or manually push updates to the library of cell therapy protocols (e.g., a library of operating conditions for the cell processing device).In some embodiments, the server computer can contain a library of cell therapy protocols, and the operator can access the library in the server computer via a network connection. In some embodiments, the operator may require a secure login or verification code to access the library in the server computer. In this configuration, the server computer itself can maintain a library of cell therapy protocols (e.g., a library of operating conditions) from which the operator selects operating conditions depending on the patient indication and the combination of GOI, peptide, small molecule.

[0045] In some embodiments, the cell treatment device can include a library of cell treatment device operating conditions or protocols. In some embodiments, the cell treatment provider system (and / or remote operator) can transmit a plurality of cell treatment device operating conditions to the cell treatment device itself. In some embodiments, a computer, such as computer 105, communicatively coupled to the cell treatment device can include a library of cell treatment device operating conditions or protocols. In some embodiments, the cell treatment provider system (and / or remote operator) can transmit a library of cell treatment protocols, including a plurality of cell treatment device operating conditions, to a computer within or outside the suite. The computer can communicate this library of operating conditions to the cell treatment device, or the computer can store the library of operating conditions and control the cell treatment device accordingly. Such cell treatment device operating conditions or protocols can be designed for a particular indication to be treated by cell therapy and for delivery of a gene of interest (GOI), peptide, or small molecule for such treatment. In other words, the cell treatment device operating conditions or protocols can correspond to a particular combination of an indication and a GOI, peptide, or small molecule. Examples of indications include, but are not limited to, bone marrow disorders such as those described in U.S. Pat. No. 10,335,456 ("Methods of Using ZSCAN4 for Rejuvenating Human Cells" by Minoru Ko) and cancers treatable by the methods described in U.S. Pat. No. 11,421,248 ("Temperature-based Transient Delivery of Nucleic Acids and Proteins to Cells and Tissue" by Minoru Ko), both of which are incorporated herein by reference in their entireties. An example of a GOI is ZSCAN4, which can be used to treat several indications, including telomere shortening, karyotypic abnormalities, and chromosomal abnormalities.Therefore, the operating conditions of the cell treatment device for such indications may be different and optimized for each of the same GOIs. Other examples of multiple GOIs include, but are not limited to, those used for genome editing, CAR T cell therapy, and PD1 therapy.

[0046] In this manner, the library of cell therapy protocols can include operating conditions for the cell processing device designed for each combination of GOI, peptide, or small molecule and indication. An operator of the cell processing device (e.g., a doctor, nurse, technician, etc.) can select an operating condition from the library (e.g., by selecting it from a touch screen display or other display) on the computer, the cell processing device, or both, depending on where the library is located. In other words, one or more processors (e.g., the cell processing device and / or computer) within or outside the suite can receive a request to treat a patient with a cell therapy based on the combination of the patient's indication and the GOI, peptide, or small molecule. The request can be a request for operating conditions for the cell processing device based on the combination of the patient's indication and the GOI, peptide, or small molecule. The request can be an input from an operator within the suite. For example, the operator can select an operating condition from the library of operating conditions designed for a particular GOI, peptide, or small molecule and patient's indication.

[0047] In response to receiving the request, the cell processing device can treat the patient's cells (e.g., blood cells) with the GOI, peptide, or small molecule according to the requested operating conditions. In some embodiments, in response to receiving a request for operating conditions, the cell processing device can treat the patient's cells with a vector (such as an adeno-associated virus, DNA plasmid, RNA, self-replicating or self-amplifying RNA, or c-srRNA) carrying the GOI, peptide, or small molecule in the cell processing device according to respective operating conditions corresponding to the combination of the patient's indication and the GOI, peptide, or small molecule. For example, the operating conditions of the cell processing device can transfer fluids between different bags for processing / processing the cells using pumps or other systems, employ centrifugation for cell separation, control (such as heating and / or cooling) the temperature of a centrifuge chamber or other storage vessel containing cells or other reagents / fluids (e.g., cell culture medium, cell separation beads, etc.), separate cells such as T cells, and / or fill the final product. In some embodiments, the cell processing device can perform any and all of these functions in a closed system.

[0048] Delivery of the GOI can be achieved using vectors (such as adeno-associated virus, DNA plasmids, RNA, self-replicating or self-amplifying RNA, c-srRNA, etc.). In some embodiments, RNA can be used, specifically temperature-controllable self-replicating RNA (c-srRNA), an example of which is disclosed in U.S. Pat. No. 11,421,248, which is incorporated herein by reference in its entirety. The unique feature of c-srRNA is that replication can occur at a specific temperature range, i.e., permissive temperature. Thus, the GOI, peptide, or small molecule is activated (i.e., produced) at the permissive temperature and inactivated (i.e., not produced) at a non-permissive temperature outside the permissive temperature range. Both activation and inactivation of the GOI, peptide, or small molecule can occur within the cell processing device. Alternatively, inactivation can occur by injecting the processed cells into the patient because the patient's body temperature is outside the permissive temperature range. Activation and inactivation can be part of the operating conditions or can be controlled independently of the operating conditions using a computer and / or the cell processing device itself. The advantages of using c-srRNA over conventional RNA in cell therapy offered in the suite are: The use of c-sRNA can support even larger genes, allowing any therapeutic gene, or even multiple genes, to be incorporated into treated cells for gene transfer. In addition, it is longer and has stronger expression than conventional RNA, but unlike self-replicating / self-amplifying RNA, it is controllable. Moreover, it is virus-free, so it can be used in non-BSL environments, such as minimal GMP suites, as opposed to centralized cell processing centers. Its temperature-controllable feature makes it suitable for precise control during culture in automated cell processing devices, in contrast to other control techniques that may require separate molecules or triggers for on-off switches. These features make c-srRNA flexible enough to be applied to almost any indication that can be addressed with cell therapy.

[0049] As explained above, the cell therapy suite can include a sequencer 109 for performing sequencing on samples taken from cell therapy patients. The sequencer can be a conventional sequencer, such as an Illumina NextSeq 550 or an Illumina iSeq 100. In some embodiments, the sequencer can be a computer-controlled and / or automated sequencer that can be used to identify sequences of GOIs or peptides for the treatment of an indication. In some embodiments, a patient can come to the cell therapy suite prior to apheresis to identify a specific GOI or peptide for cell therapy treatment. In some embodiments, when treating a cancer patient, sequencing can be performed to identify the patient's neo-antigens. The results of the sequencing can be stored in a sequencer and / or computer inside or outside the suite. In some embodiments, the results of the sequencing are sent (either by the sequencer itself or by the computer) to the cell therapy provider system and stored. If multiple cell therapy facilities are installed in a particular area, it is not necessarily the case that only one or all of the facilities are equipped with a sequencer. Instead, facilities without a sequencer can receive the sequencing results via any network communication. In this scenario, a patient may visit a facility for sequencing and another facility to undergo other treatments / processes such as apheresis and / or reinfusion of processed blood cells.

[0050] In some embodiments, the suite, sequencer, and / or computer can include one or more processors configured to receive / send electronic information (e.g., a library of cell therapy protocols). In some embodiments, the electronic information and / or library of cell therapy protocols can include maintenance / update pings or commands for the sequencer. For example, the sequencer can receive a library of cell therapy protocols that includes sequence procedure information for sequencing a particular patient's specimen. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the sequencer itself, either within or outside the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can send the library of cell therapy protocols, including sequencing information for the sequencer, to a computer, either within or outside the suite. The computer can communicate this information to the sequencer or store this information to control the sequencer. The cell therapy provider system (and / or remote operator) can update and / or maintain this information for the sequencer. For example, the cell therapy provider can use the network connection to push updates to sequencer settings from the cell therapy provider's system (and / or a remote operator) to the cell therapy suite's computer and / or sequencer (which can then transmit that information to the apheresis device). This can be done automatically or manually by the cell therapy provider's personnel. In response to receiving the sequencing procedure information and / or receiving a request from the operator, the sequencer can perform a sequence to identify a GOI or peptide for treatment of the indication. Thus, a patient can visit the cell therapy suite for a biopsy for identification of a GOI or peptide.

[0051] As explained above, the cell therapy suite may include an RNA generation unit 110 for generating RNA carrying a GOI, peptide, or small molecule for the treatment of an indication. In some embodiments, the RNA generation unit can be a vector generation unit configured to generate vectors (such as adeno-associated virus, DNA plasmid, RNA, self-replicating or self-amplifying RNA, or c-srRNA) expressing the GOI, peptide, or small molecule for the treatment of an indication on a cell processing device in the suite. The RNA generation unit is a self-contained, standalone machine that, once supplied with reagents and sequence and protocol data, can perform all steps required to generate RNA in a packed format at research or GMP grade levels. In some embodiments, the RNA generation unit can be a computer-controlled and / or automated RNA generation unit. In some embodiments, the RNA generation unit can include one or more processors configured to receive / send electronic information. In some embodiments, the electronic information can include the GOI or peptide identified by the sequencer. In some embodiments, the electronic information can be sent from the sequencer itself, the computer, and / or the cell therapy provider system (and / or a remote operator). In response to receiving information regarding the GOI or peptide identified by the sequencer, the RNA generation unit can load the identified GOI or peptide into a vector or vehicle. In some embodiments, the RNA generation unit can load the identified GOI into a vector in response to an operator's input. In some embodiments, the RNA generation unit can be pre-configured to generate a backbone of a c-srRNA vehicle. The RNA generation unit can generate c-srRNA by loading the identified GOI, peptide, or small molecule into the backbone of a c-srRNA vehicle. Additionally, the RNA generation unit can include creating plasmid DNA and capping the final RNA product.

[0052] Once a GOI or peptide is identified by a sequencer in one suite, information about that GOI or peptide can be sent locally to an RNA generation unit in the same suite. In some embodiments, a suite may not have an RNA generation unit. Thus, a cell therapy suite with a sequencer (but no RNA generation unit) can send the sequence information of the GOI or peptide obtained by its sequencer to an RNA generation unit in another cell therapy suite for RNA generation. In some embodiments, the sequencer can send information to a computer within or outside the cell therapy suite, which sends the information to a cell therapy provider system (and / or a remote operator), which then sends the information to a therapy suite that includes an RNA generation unit.

[0053] In some embodiments, the electronic information and / or library of cell therapy protocols can include a maintain / update ping or command to the RNA generation unit. For example, the RNA generation unit can receive a library of cell therapy protocols including RNA generation procedure (or other vector generation procedure disclosed herein) information for a setup to generate RNA for a particular patient. In some embodiments, the cell therapy provider system is configured to send the electronic information to the RNA generation unit itself in the suite. In some embodiments, the cell therapy provider system can send the RNA information of the RNA generation unit to a computer in the suite. The computer can communicate this information to the RNA generation unit or store this information and control the RNA generation unit. In some embodiments, the cell therapy provider system (and / or remote operator) can update and / or maintain this information on the RNA generation unit. For example, using a network connection, the cell therapy provider can push updates of information including RNA generation settings from the cell therapy provider system (and / or remote operator) to a computer in or outside the cell therapy suite (which can then send the information to the RNA generation unit) and / or to the RNA generation unit. This can be done automatically or manually by cell therapy provider personnel.

[0054] As discussed above, the cell therapy suite can include a refrigerator 106 for storing reagents and / or samples used in the cell therapy procedures. The refrigerator can be a conventional refrigerator or a stackable refrigerator capable of reaching 4° C., −20° C., etc. In some embodiments, the refrigerator can be computer controlled and / or automated.

[0055] In some embodiments, the suite, refrigerator, and / or computer can include one or more processors configured to receive electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information and / or library of cell therapy protocols can include refrigerator maintenance / update / setting pings or commands. For example, the refrigerator can receive temperature setting information for storing patient samples. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the refrigerator itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can send the refrigerator information to a computer in or outside the suite. The computer can communicate this information to the refrigerator or store this information and control the refrigerator. The cell therapy provider system can update and / or maintain this information for the refrigerator. For example, using a network connection, the cell therapy provider can push updates to the refrigerator settings from the cell therapy provider system (and / or remote operator) to the computer (which can then send the information to the refrigerator). This can be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from the operator, the refrigerator can adjust its settings.

[0056] As discussed above, the cell therapy suite may include a freezer 107 for storing reagents and samples used in cell therapy procedures. The freezer may be a conventional freezer or multiple freezers, such as a freezer that can reach -80° C. In some embodiments, the freezer may be computer controlled and / or automated.

[0057] In some embodiments, the suite, freezer, and / or computer can include one or more processors configured to receive / send electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information and / or library of cell therapy protocols can include freezer maintenance / update / setting pings or commands. For example, the freezer can receive temperature setting information for storing patient samples. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the freezer itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can send freezer information to a computer in or outside the suite. The computer communicates this information to the freezer or the computer stores this information and controls the freezer. The cell therapy provider system (and / or remote operator) can update and / or maintain this information for the freezer. For example, using a network connection, the cell therapy provider can push updates to the refrigerator settings from the cell therapy provider system (and / or remote operator) to the computer and / or freezer(s) in the cell therapy suite (which can then send the information to the freezer). This can be done automatically or manually by the cell therapy provider's personnel. In response to receiving the information and / or in response to receiving a request from the operator, the freezer can adjust its settings.

[0058] As discussed above, the cell therapy suite may include a biosafety hood 111. The biosafety hood may be used during some parts of the cell therapy procedure, such as making sterile connections within the biosafety hood. In some embodiments, the biosafety hood may be a compact biosafety hood. The biosafety hood may be any conventional biosafety hood. In some embodiments, the biosafety hood may be a computer controlled and / or automated biosafety hood.

[0059] In some embodiments, the suite, biosafety hood, and / or computer may include one or more processors configured to receive / send electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information and / or library of cell therapy protocols may include biosafety hood maintenance / update / configuration pings or commands. For example, the biosafety hood may receive specific configuration information related to a patient's cell therapy procedure. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the biosafety hood itself within its suite. In some embodiments, the cell therapy provider system (and / or remote operator) may send information for the biosafety hood to a computer within or outside of its suite. The computer communicates this information to the biosafety hood or stores this information, thereby controlling the biosafety hood. The cell therapy provider system (and / or remote operator) may update and / or maintain this information regarding the biosafety hood. For example, using a network connection, the cell therapy provider can push updates to refrigerator settings from the cell therapy provider system (and / or a remote operator) to the computer and / or biosafety hood of the cell therapy suite (which can then send the information to the biosafety hood). This can be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from the operator, the biosafety hood can adjust its settings.

[0060] As described above, the cell therapy suite can include an incubator 108 to incubate cells for cell therapy treatment. The incubator can be a conventional incubator. In some embodiments, the incubator can be a computer-controlled and / or automated incubator. In some embodiments, the incubator can be used for long-term storage of cells. Additionally, the cells can be stored in an environment with a set temperature and / or CO2 percentage. For example, for a process of several days / weeks, such as CAR-T cell therapy, the cells can be incubated in an incubator at about 33° C. instead of incubating in a cell treatment device. In some embodiments, the cells can be incubated in a cell treatment device.

[0061] In some embodiments, the suite, incubator, and / or computer can include one or more processors configured to receive / send electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information and / or library of cell therapy protocols can include incubator maintenance / update / configuration pings or commands. For example, the incubator can receive information of the patient's cell culture settings. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the incubator itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can send the incubator information to a computer in or outside the suite. The computer communicates this information to the incubator or stores this information and controls the incubator. The cell therapy provider system (and / or remote operator) can update and / or maintain this information for the incubator. For example, using a network connection, the cell therapy provider can push updates to the incubator settings in the cell therapy suite from the cell therapy provider system (and / or remote operator) to a computer (which can then send the information to the incubator). This can be done automatically or manually by the cell therapy provider's personnel. In response to receiving the information and / or in response to receiving a request from an operator, the incubator can adjust its settings.

[0062] As described above, the cell therapy suite can include a storage rack 112 for storing reagents and various other materials for the cell therapy treatment process. The storage rack can be a conventional storage rack. In some embodiments, the storage rack can have sensors (e.g., weight sensors) for tracking the amount of various materials on the storage rack. In this manner, the storage rack can be configured to track the usage of various materials used in the cell therapy treatment process. In some embodiments, the storage rack can be a computer-controlled and / or automated storage rack.

[0063] In some embodiments, the suite, storage rack, and / or computer can include one or more processors configured to receive / send electronic information, such as a library of cell therapy protocols. In some embodiments, the storage rack can send information regarding the amount of material stored in the storage rack to the computer (and thus the cell therapy provider system) and / or the cell therapy provider system (and / or remote operator). In some embodiments, the electronic information and / or library of cell therapy protocols can include maintenance / update / configuration pings or commands to the storage rack. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the storage rack itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) can send information of the storage rack to a computer within or outside the suite. The computer can communicate this information to the storage rack or the computer can store this information and thereby control the storage rack. The cell therapy provider system (and / or remote operator) can update and / or maintain this information of the storage rack. For example, using a network connection, the cell therapy provider can push updates to the storage rack's settings from the cell therapy provider system (and / or a remote operator) to a computer in the cell therapy suite (which can then send the information to the storage rack) and / or to the storage rack. This can be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from the operator, the storage rack can adjust its settings and / or send additional information.

[0064] In some embodiments, the cell therapy suite can include a power source 113 to provide power to the suite and various components of the suite. The power source can be any conventional power source, such as a battery, a gas / diesel generator, a solar generator, a wind generator, or a generator powered by other energy sources. In some embodiments, the power source can be an uninterruptible power supply. In some embodiments, the power source can provide regulated power to ensure all components within the suite function properly. In some embodiments, the power source can be a computer controlled and / or automated storage power supply. Having a suite with its own power source allows the suite to be an independent unit.

[0065] In some embodiments, the suite, the power supply, and / or the computer may include one or more processors configured to receive and / or transmit electronic information, such as a library of cell therapy protocols. In some embodiments, the electronic information and / or library of cell therapy protocols may include power supply maintenance / update / configuration pings or commands. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to transmit electronic information to the power supply itself in the suite. In some embodiments, the cell therapy provider system (and / or remote operator) may send information of the power supply to a computer in or outside the suite. The computer may also communicate this information to the power supply or store this information and control the power supply. The cell therapy provider system (and / or remote operator) may update and / or maintain this information about the power supply. For example, using a network connection, the cell therapy provider may push updates to the power supply settings from the cell therapy provider system (and / or remote operator) to the computer and / or power supply in the cell therapy suite (the computer may then transmit the information to the power supply), such as information to adjust the power usage of a smart uninterruptible power supply. This may be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from an operator, the power supply may adjust its settings.

[0066] In some embodiments, the cell therapy suite can include a gas supply or gassing device, such as CO2 and / or nitrogen cylinders used for cell processing and / or incubation. In some embodiments, the gas supply can be provided outside the suite with a supply tube to the cell processing device and / or incubator. In some embodiments, gas can be supplied to the cell processing device and / or incubator based on information received from the cell processing device and / or incubator. In some embodiments, the gas supply or source can be part of the cell processing device and / or incubator. In some embodiments, the gas supply can be communicatively coupled to any and all components and / or cell therapy provider systems within or outside the suite for sending and receiving electronic information.

[0067] In some embodiments, the cell therapy suite includes a patient chair 115, a waste receptacle 116, and an operator chair 117. The patient chair can be where the patient sits during a cell therapy procedure. The operator chair can be where the operator sits during a cell therapy procedure. The waste receptacle can be where waste and / or biohazard waste is stored. In some embodiments, the patient chair, waste receptacle, and / or operator chair can be communicatively coupled to any and all components and / or cell therapy provider systems (and / or remote operators) within and outside the treatment suite to transmit and / or receive electronic information. In some embodiments, the cell therapy suite can include a sterile connection device (not shown), such as from Terumo Corporation. The sterile connection device can be used to connect tubing. In some embodiments, the sterile connection device can be used to connect tubing without the need for a biosafety hood / cabinet. In some embodiments, the sterile connection device can be communicatively coupled to any and all components and / or cell therapy provider systems within and outside the suite to transmit and / or receive electronic information.

[0068] In some embodiments, the cell therapy suite can include one or more displays 118 (e.g., graphical user interfaces) for displaying information received from or transmitted to components within or outside the suite. In some embodiments, the one or more displays can be located external to or remote from the cell therapy suite. As described in more detail herein, in some embodiments, the display can be a heads-up display (HUD). In some embodiments, at least one display can provide visual cues when performing steps of a cell therapy protocol. In some embodiments, at least one display can also provide audio cues when performing steps of a cell therapy protocol. In some embodiments, the suite, display, and / or computer can include one or more processors configured to receive / transmit electronic information, such as a library of cell therapy protocols. In some embodiments, the display can transmit information regarding where an operator is in the cell therapy process to the computer (and then to the cell therapy provider system) and / or the cell therapy provider system (and / or to a remote operator). In some embodiments, the electronic information and / or library of cell therapy protocols can include maintenance / update / configuration pings or commands to the display(s). In some embodiments, the cell therapy provider system (and / or remote operator) is configured to transmit electronic information to the display itself. In some embodiments, the cell therapy provider system (and / or remote operator) can transmit information for the display(s) to a computer within or outside the suite. The computer can communicate this information to the display or the computer can store this information and control the display. The cell therapy provider system (and / or remote operator) can update and / or maintain this information for the display.For example, using a network connection, the cell therapy provider can push display setting updates from the cell therapy provider system (and / or a remote operator) to the computer and / or displays within or outside the cell therapy suite (which can then send the information to the display). This can be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from the operator, the display can adjust its settings, display certain information, and / or send additional information.

[0069] In some embodiments, the information comprising the library of cell therapy protocols comprises instructions on how to execute at least one step or steps of a respective cell therapy protocol from the library of cell therapy protocols corresponding to a combination of a patient indication and a GOI. In some embodiments, in response to receiving a request to treat a patient with cell therapy, the system can display how to execute at least one step of a respective cell therapy protocol from the library of cell therapy protocols corresponding to a combination of a patient indication and a GOI.

[0070] In some embodiments, the cell therapy suite may include one or more image capture devices 119 (e.g., cameras) for taking images of anything in the cell therapy suite (e.g., components of the cell therapy suite, the patient, materials used by the components of the cell therapy suite). In some embodiments, the images may be video streams. In some embodiments, in response to receiving a request to treat a patient with cell therapy, the imaging device(s) may take images of the cell therapy suite. In some embodiments, the imaging device may be a component of a heads-up display (e.g., a front camera of a HUD). In some embodiments, the one or more image capture devices may be located at a location remote from the cell therapy suite. In some embodiments, the suite, image capture device(s), and / or computer may include one or more processors configured to receive / send electronic information, such as a library of cell therapy protocols. In some embodiments, at least one image capture device may capture an image of where an operator is in the cell therapy process and send it to the computer (and then to the cell therapy provider system) and / or the cell therapy provider system (and / or to a remote operator). In some embodiments, the electronic information and / or library of cell therapy protocols can include maintenance / update / configuration pings or commands for the at least one image capture device. In some embodiments, the cell therapy provider system (and / or remote operator) is configured to send electronic information to the at least one image capture device itself. In some embodiments, the cell therapy provider system (and / or remote operator) can send information about the at least one image capture device to a computer within the suite or outside the suite. The computer can communicate this information to the at least one image capture device or the computer can store this information and thereby control the at least one image capture device.The cell therapy provider system (and / or remote operator) can update and / or maintain this information for the at least one image capture device. For example, the cell therapy provider can use a network connection to push updates to the settings of the at least one image capture device from the cell therapy provider's system (and / or remote operator) to a computer (which can then transmit the information to the at least one image capture device) and / or to at least one image capture device inside or outside the cell therapy suite. This can be done automatically or manually by cell therapy provider personnel. In response to receiving the information and / or in response to receiving a request from the operator, the at least one image capture device can adjust its settings, capture an image, and / or transmit additional information.

[0071] As discussed above, the cell therapy suite can include a computer 105. In some embodiments, the computer 105 can be located at a location outside (e.g., remote) from the suite. In some embodiments, the computer 105 can serve as the brains of the suite in that it can send information (e.g., commands) to any and all other components in the suite. In some embodiments, an operator can use the computer for onboarding patients. In some embodiments, the computer can be the main connection point to the cell therapy provider system (and / or remote operator). As such, any information sent to the cell therapy suite from the cell therapy provider system (and / or remote operator), such as a library of cell therapy protocols, is sent to the computer, which then communicates to other components within and outside the cell therapy suite to perform the cell therapy treatment.

[0072] In some embodiments, the computer can include a display, such as a graphical user interface, for an operator to interact with the computer. In some embodiments, the computer can include the display 118 described above. In some embodiments, the display can be separate from the computer. Additionally, the display can provide the operator with instructions (which can be included in a library of cell therapy protocols) specific to any step in the therapeutic process of the cell therapy treatment, including instructions specific to the operating conditions the operator has selected for the cell treatment device. In some embodiments, the display can provide the operator with training instructions (which can be included in a library of cell therapy protocols) on how to operate any component of the process of the cell therapy treatment, such as various components in a suite.

[0073] In some embodiments, the computer can receive patient information directly from an operator or component of the cell therapy system, or from the cell therapy provider system (and / or remote operator) (library of cell therapy protocols). In some embodiments, the computer (or display) can execute an operator (e.g., technician, doctor, nurse, etc.) assistance or training program, such as an augmented reality or virtual reality assistance or training program. In some embodiments, the library of cell therapy protocols can include an operator assistance or training program. For example, when a request for training of an operator of the cell therapy system is received, the system can execute steps of each cell therapy patient protocol from the library of cell therapy protocols (including the operator training program) that correspond to a patient indication and a GOI, peptide, or small molecule combination. Thus, the operator can be trained on how to perform a cell therapy for a particular patient indication and a GOI, peptide, or small molecule combination.

[0074] 3 is a flow chart depicting an exemplary method 300 of providing cell therapy guidance, according to some embodiments. As described in detail below, method 300 may enable a system (such as system 100) to receive a cell therapy protocol for a combination of a patient indication and a gene of interest (GOI), peptide, or small molecule; in response to receiving the cell therapy protocol, display a method for performing a step of the cell therapy protocol; determine whether a step of the cell therapy protocol is complete; and in response to determining whether a step of the cell therapy protocol is complete, display a method for performing another step of the cell therapy protocol. Additionally, method 300 may enable the system to receive a cell therapy protocol for a combination of a patient indication and a GOI, peptide, or small molecule; in response to receiving the cell therapy protocol, capture an image of the cell therapy suite; transmit the image of the cell therapy suite to a location outside of the cell therapy suite; and in response to transmitting the image of the cell therapy suite, receive instructions on how to perform a step of the cell therapy protocol.

[0075] In some embodiments, method 300 may be performed, in whole or in part, by one or more of the components of a system, such as system 100, described in Figure 1 and the corresponding description. In some embodiments, any one or more of the aspects of method 300 may be combined, in whole or in part, with any one or more of the components of Figure 1 and / or with any one or more of the systems, methods, devices, and / or techniques described elsewhere herein.

[0076] At block 301, in some embodiments, the system may receive a cell therapy protocol for a combination of a patient indication and a GOI, peptide, or small molecule. In some embodiments, the cell therapy protocol may be a cell therapy protocol from a library of cell therapy protocols. In some embodiments, the cell therapy protocol may not be a cell therapy protocol from a library of cell therapy protocols. In some embodiments, the system may receive a cell therapy protocol in response to a request for treatment of a patient with cell therapy and / or a request for training of an operator on use of a cell therapy suite. In some embodiments, the system may receive a cell therapy protocol in response to a request for treatment of a patient with cell therapy and / or a request for training of an operator on use of a cell therapy suite by a remote monitor (e.g., an operator supervisor) or cell therapy provider personnel. At block 302, in some embodiments, in response to receiving the cell therapy protocol, the system may display instructions on how to perform the steps of the cell therapy protocol. The instructions on how to perform the steps of the cell therapy protocol may include instructions on how to operate any components of the cell therapy suite disclosed herein and / or what actions to take with respect to the patient. As discussed above, the system may include at least one display. In some embodiments, the system includes a heads-up display (HUD), where instructions on how to perform the first step of the cell therapy protocol are displayed on the HUD.

[0077] In some embodiments, the cell therapy protocol may include operator assistance or training programs. In some embodiments, these operator assistance or training programs may provide training / execution programs that provide step-by-step instructions to an operator in or outside the suite on how to perform a cell therapy for a given patient, including how to operate the various components in the suite and what procedures to perform on the patient. In some embodiments, these programs may be run similar to step-by-step video examples on a heads-up display (HUD) that the operator may wear while performing a cell therapy procedure on a patient or while learning how to perform a cell therapy procedure on a given patient.

[0078] In some embodiments, in response to receiving a cell therapy protocol, the system can audibly instruct how to perform the steps of the cell therapy protocol. For example, in some embodiments, the display can include a speaker that can provide audible instructions (e.g., audio cues) or other audio-related instructions (e.g., a remote supervisor can use the speaker to speak to the operator).

[0079] At block 305, in some embodiments, in response to receiving the cell therapy protocol, the system can capture an image of the cell therapy suite and / or the patient. In some embodiments, the HUD can have at least one image capture device (e.g., a front camera (as well as additional cameras for peripheral and other fields of view)) as previously described. In some embodiments, an operator unfamiliar with cell therapy procedures can use an augmented reality program with overlays (e.g., color highlighting overlays) and step-by-step instructions to navigate the entire suite for a cell therapy procedure.

[0080] At block 306, in some embodiments, the system can transmit images of the cell therapy suite and / or patient to a location outside the cell therapy suite (e.g., a cell therapy provider system). For example, the system can transmit images of the cell therapy suite and / or patient to the cell therapy provider system. In some embodiments, the location outside the cell therapy suite can be a display for a remote operator (e.g., a supervisor) or cell therapy provider personnel. In some embodiments, the images can be a video stream. In some embodiments, the images can be stored in any component of the systems disclosed herein, including the cell therapy provider system (and / or the remote operator). In some embodiments, the images can include everything an operator would see through the HUD, including any alerts, instructions, patient data, and / or suite data. In some embodiments, the images can be used for facial recognition to confirm patient identification. In some embodiments, the remote operator can confirm patient identification. In some embodiments, the facial recognition of the patient identification is confirmed by machine learning or AI-assisted algorithms.

[0081] At block 307, in some embodiments, in response to transmitting an image of the cell therapy suite (or patient), the system can receive instructions on how to perform the steps of the cell therapy protocol. In some embodiments, in response to receiving the instructions on how to perform the steps of the cell therapy protocol, the system can display the instructions on how to perform the steps of the cell therapy protocol. In some embodiments, the HUD can include at least one front camera, as described above. In some embodiments, the cell therapy suite can synchronize with the HUD and begin real-time monitoring and / or recording upon receiving the cell therapy protocol (or upon donning the HUD). In some embodiments, the HUD can be commercially available augmented reality or virtual reality glasses or goggles. In some embodiments, the at least one image capture device can record the actions of the operator so that the operator can be monitored in real-time to assist, coach, and guide the operator in any part of the cell therapy procedure. In some embodiments, a remote operator (e.g., an operator not wearing a HUD) can double-check the operator's cell therapy procedure / training steps. In some embodiments, instructions on how to perform the steps of the cell therapy protocol can be provided from a location outside the cell therapy suite, such as a remote operator (e.g., a supervisor) or cell therapy provider personnel viewing a video stream of the operator within the cell therapy suite. In some embodiments, at least one image capture device can record video for live or asynchronous remote assistance / training / monitoring. For example, in some embodiments, instructions on how to perform the steps of the cell therapy protocol can be from a person (e.g., a supervisor) viewing an image of the cell therapy suite (or patient) at a location outside the cell therapy suite. In some embodiments, the HUD includes a voice and / or video calling device so that the remote operator (e.g., a supervisor) or cell therapy provider personnel can provide instructions to the operator via voice and / or video calling.In some embodiments, these instructions may include technical assistance for operating components of the cell therapy suite. In some embodiments, video may be streamed bidirectionally between the operator and the HUD of a remote operator (e.g., a supervisor) or cell therapy provider personnel. Additionally, in some embodiments, the instructions may be streamed to the operator's HUD. In some embodiments, the remote operator (e.g., a supervisor) or cell therapy provider personnel may also use augmented reality to experience telepresence and / or cell therapy procedures through the eyes of the operator wearing the HUD. In some embodiments, the instructions on how to perform a step of a cell therapy protocol may include a video of an example of the execution of that step. At least one display may display a video of an example of the execution of that step.

[0082] In some embodiments, the HUD can be an augmented reality HUD, where the method of performing the steps of the cell therapy protocol is overlaid on the actual components of the cell therapy suite. In some embodiments, the images captured by the at least one image capture device can be sent to a processor of any component disclosed herein (including the cell therapy provider system) for processing to highlight, display, or identify the components of the cell therapy suite. For example, for a step of the cell therapy protocol, the HUD can display an outline around the component or components of the system that correspond to the step of the cell therapy protocol, or light or highlight the component of the system to inform the operator that the component is used in the step of the cell therapy protocol. Such highlighting, displaying, or identifying can be achieved by a computer algorithm, such as an AI-assisted algorithm or a machine learning algorithm. For example, the images captured by the at least one image capture device can be sent to a processor of any component disclosed herein (including the cell therapy provider system (and / or remote operator)) and compared to a common set of images or a training set of images to highlight, display, identify, or indicate errors for the components for each step.

[0083] For example, in some embodiments, the system may highlight, display, or identify a component of the cell therapy suite that the operator should use to perform a step of the cell therapy protocol. For example, the HUD may highlight a cell processing device in the cell therapy suite to perform a cell processing step of the cell therapy protocol. In some embodiments, the image of the cell therapy suite may include an image of a component identifier for a component of the cell therapy suite. These component identifiers may be on the component of the cell therapy suite. In some embodiments, the instructions for how to perform a step of the cell therapy protocol may include instructions for how to operate the component of the cell therapy suite. In some embodiments, the component identifier may be a QR code or barcode corresponding to the component of the cell therapy suite. Thus, by taking an image of the component identifier, the system may transmit the identification information of the component corresponding to the component identifier to the cell therapy suite (e.g., a display). In some embodiments, the captured image may be recorded for batch processing and / or treatment records. In some embodiments, the recorded image may be stored in any component disclosed herein (including the cell therapy provider system).

[0084] In some embodiments, augmented or virtual reality can be used to generate a simulated cell therapy suite for virtually simulated cell therapy training (e.g., gesture-based mock training) or simulated / virtual cell therapy protocols. In some embodiments, the HUD can be a virtual reality HUD and the instructions on how to perform the steps of the cell therapy protocol include a virtual or simulated cell therapy suite. In other words, in some embodiments, an operator who is new to cell therapy procedures or does not have access to a cell therapy suite can use a virtual reality program that can create a virtual or simulated cell therapy suite and step-by-step instructions for operating the entire virtual suite for a cell therapy procedure. In some embodiments, the HUD can match an actual treatment HUD, but all visual and audio aspects related to the treatment (e.g., environment, patient, materials, components) can be simulated computer graphics. In some embodiments, an operator can be trained, approved, certified, or registered to perform cell therapy in a cell therapy suite without being in the cell therapy suite. All components of the cell therapy suite can be simulated so that the operator in training can receive instructions on how to perform the cell therapy protocol as if they were actually in the cell therapy suite. In some embodiments, an operator can simulate performing steps of a cell therapy protocol in a virtual or simulated cell therapy suite by making gestures (either with their hands or other input devices such as a controller) that are associated with actual movements and operations if they were in the actual cell therapy suite. In some embodiments, appropriate completion records, metrics, and / or data of training steps can be monitored and / or recorded.

[0085] In some embodiments, any of the components disclosed herein, including the cell therapy provider system (and / or remote operator), can include a database of operators who have completed cell therapy training (e.g., registered operators) and / or potential operators. In some embodiments, this database can include, among other things, the procedures for which each operator is trained, the number of operations performed by each operator, and / or any evaluation, feedback, and / or review of the operator's performance (e.g., provided by a supervisor), etc. In some embodiments, the database can include evaluation and / or feedback for a given operator. In some embodiments, the evaluation, feedback, and / or review can be provided by cell therapy provider personnel, the operator, any supervisor, or any patient of the operator. In some embodiments, the database can be stored and / or maintained on any of the components disclosed herein, including the cell therapy provider system (and / or remote operator). In some embodiments, the database can be accessed via the internet / web, a smartphone (e.g., an application for the smartphone), any display (including the HUD (AR and VR) displays disclosed herein) of the cell therapy system (both those located within the cell therapy suite and those located outside the cell therapy suite). In some embodiments, the database can be accessed by cell therapy provider personnel, operators, supervisors, and / or patients. In some embodiments, cell therapy provider personnel, operators, supervisors, or patients can veto, veto, or accept procedures and / or operators through the database.

[0086] At block 303, in some embodiments, the system may determine whether a step of the cell therapy protocol is completed. In some embodiments, determining whether a step of the cell therapy protocol is completed includes receiving an operator input indicating that a step of the cell therapy protocol is completed. In some embodiments, the system may display a digitized checklist for the step of the cell therapy protocol. In some embodiments, as the operator completes a step, they may provide an input indicating that the step is completed (e.g., clicking a digital box, making a gesture, speaking a verbal command, or simply performing the step itself). In some embodiments, determining whether a step of the cell therapy protocol is completed includes determining whether the provider has made a gesture corresponding to the step of the cell therapy protocol. This applies to both the operator in the cell therapy suite and the operator in the virtual reality training environment. For example, in the virtual reality training environment, the HUD may indicate that the operator should turn on a component of the simulated cell therapy suite. Upon making a gesture to turn on a component of the simulated cell therapy suite, the system determines that the step of the cell therapy protocol is completed. In some embodiments, determining whether a cell therapy protocol step is complete can include a remote operator (e.g., a supervisor) or cell therapy provider personnel determining whether a cell therapy protocol step is complete. In some embodiments, the system can automatically determine whether a cell therapy protocol step is complete using images captured by an image capture device. For example, images received from the image capture device can be compared to a common set of images or a trained set of images to determine whether a cell therapy protocol step is complete. In some embodiments, determining whether a cell therapy protocol step is complete can be determined from feedback from one or more components of the system. In some embodiments, the feedback can be a change in a parameter of one or more components.For example, a sensor in one of the system's components may detect a change in a parameter (e.g., a change in weight of a storage rack, refrigerator, etc., or a change in electrical conductivity) that may be based on a change or manipulation made by an operator. The component that experiences the parameter change may communicate with the system to inform the system that the step of the cell therapy protocol corresponding to the parameter change has been completed.

[0087] In some embodiments, in response to determining that a step of the cell therapy protocol is completed, the system (e.g., display, computer, controller) can provide visual, auditory, or tactile feedback.

[0088] In some embodiments, in response to determining that a step of the cell therapy protocol is completed, the system can display instructions on how to perform another step of the cell therapy protocol, in block 304. In some embodiments, the other step can be a subsequent step of the cell therapy protocol, or a step that follows a previously completed step.

[0089] The cell therapy provider system can update and / or maintain various programs to assist the operator in performing or learning a given cell therapy procedure. For example, using a network connection, the cell therapy provider can push updates to computer programs (which can be in a library of cell therapy protocols) from the cell therapy provider system (and / or a remote operator) to computers or displays inside or outside the cell therapy suite. This can be done automatically or manually by cell therapy provider personnel. In some embodiments, the updates are for the modification of existing computer programs or the addition of new computer programs for cell therapy treatment or training. In some embodiments, an augmented reality program running on a headset or other device can communicate with other components (e.g., cell processing devices, computers, etc.) to appropriately display real-time information of steps in the cell therapy process.

[0090] In some embodiments, augmented reality or virtual reality can be used for physical training and monitoring in the actual cell therapy suite. The use of augmented reality or virtual reality may reduce regulatory requirements and human error issues associated with cell therapy. Augmented reality or virtual reality can improve training of workers or operators and / or improve the speed and efficiency of onboarding. In some embodiments, augmented reality or virtual reality can reduce human error.

[0091] In some embodiments, any data, instructions, and / or other types of information can be displayed on at least one display of the system. For example, in some embodiments, the at least one display can display environmental monitoring data from the cell therapy suite, patient health monitoring, and / or alerts of emergency situations related to the patient and / or cell therapy protocol. FIG. 4 illustrates an example of an augmented reality or virtual reality HUD 400 according to some embodiments disclosed herein. As shown in FIG. 4, the HUD can display patient health data 401. In some embodiments, the patient health data can be obtained from any component disclosed herein (including the cell therapy provider system) that measures data related to the patient's health. In some embodiments, the HUD can display a video call 402. In other words, the HUD can display footage of a remote operator (e.g., a supervisor) or cell therapy provider personnel monitoring / assisting the operator performing the cell therapy procedure. In some embodiments, the video can be a video of how to perform a certain step of the cell therapy protocol. In some embodiments, the HUD can display any warnings 403 or emergency situations related to the patient and / or cell therapy protocol. In some embodiments, the HUD can display the current time 404. In some embodiments, the HUD can display at least one step (e.g., the current step) 405 of the cell therapy protocol. In some embodiments, the HUD can display an estimated time remaining to complete at least one step (e.g., the current step).

[0092] To expand and accelerate access to cell therapy to the general public, cell therapy service providers may install various versions of the cell therapy suites described herein in various locations, including within hospitals, depending on the needs of a particular hospital. In some embodiments, the cell therapy provider may partially or fully cover the cost of installing the suites in a location to ease the financial burden in areas where resources may not be allocated to cell therapy. For example, the cell therapy provider may enter into a contract with another entity, such as a hospital or medical facility, city, state, etc., and the provider may charge the entity a fee for access to the cell therapy suite and / or a fee for the actual use of the cell therapy suite.

[0093] In some embodiments, such subscription services allow a subject to request a cell therapy provider to create a c-srRNA for a particular indication. The cell therapy provider can then find or select an appropriate GOI, peptide, or small molecule to treat the particular indication and generate the c-srRNA with that GOI, peptide, or small molecule. Generation of the carrier vector (e.g., adeno-associated virus, DNA plasmid, RNA, self-replicating RNA, self-amplifying RNA, c-srRNA, etc.) can be performed in the cell therapy suite, provided by the cell therapy provider, or at an off-site location.

[0094] The cell therapy provider system (and / or remote operator) can verify that the operator is indeed able to use not only the suite but also the various programs and instructions on how to provide the cell therapy to the patient by providing a validation key for the subscription on a display external to the computer and / or suite. For example, once a user logs into a computer in the suite, the suite computer has access to all of the functionality provided by the cell therapy provider system (and / or remote operator). This relationship is a client-server configuration.

[0095] Additionally, subscribers to the cell therapy provider system (and / or remote operator) may incur no additional cost as updates are sent directly to the suite as new therapies or indications are added, as well as improvements to cell therapy clinical protocols, changes required by regulators, and substitutions due to supply or logistics.

[0096] Example process of an operator performing cell therapy in the suite The following is an exemplary process for providing cell therapy to a patient. First, the patient arrives and may be onboarded by an operator (e.g., technician or physician). The operator may use the AR device with HUD for processing / training / tracking procedures. Next, the operator may set up apheresis for the patient while the patient is seated. The operator may receive patient data on a computer or AR device and perform treatment based on that data. In some embodiments, the apheresis device may receive information about which procedure the patient is undergoing and automatically retrieve the settings over the network. Apheresis may then be performed. Reagents and consumables may be retrieved from a storage rack where usage can be tracked, and waste / bio-waste containers hold associated waste. The apheresis device may perform cell separation by type, or the cell processing device may perform that function. In some embodiments, the patient may receive post-apheresis care from the operator and then leave. Next, the operator may attach reagents, tubing sets, etc. to the cell processing device (possibly prompted by augmented reality (AR)). The operator can then select the relevant program from a library on the cell processing device or computer, which is updated in real time by the computer or cell therapy provider system (and / or a remote operator). The operator can perform cell isolation, cell processing, etc., all of which can be done automatically by the cell processing device while the operator changes connections, adds or removes reagents and bags. If the processed cells require incubation or are stored at low temperatures, an incubator or refrigerator(s) and freezer can be used. The patient can then return within 24 hours or within a few weeks, all according to protocol. The operator can then set up the patient infusion and infuse the processed cells back into the patient. The operator then cares for the patient post-infusion, and the patient can leave while the operator cleans the suite and prepares for the next treatment.

[0097] Exemplary Computing System 5 illustrates an exemplary computing system, according to some embodiments. Computing system 2800 can be a component of any of the systems for cell therapy, such as system 100 and / or its subcomponents described above with respect to FIG. 1. For example, any and all of the components described in FIG. 1 can include their own computing system. In some embodiments, computing system 2800 can be configured to perform all or a portion of a method for providing cell therapy, such as all or a portion of method 200 or method 300 described above with respect to FIGs. 2 and 3.

[0098] The computing system 2800 may include a host computer connected to a network. The computing system 2800 may be a client computer or a server. As shown in Figure 5, the computing system 2800 may be any suitable type of microprocessor-based device, such as a personal computer, a workstation, a server, or a handheld computing device such as a mobile phone or tablet. The computing system may include, for example, one or more of a processor 2810, an input device 2820, an output device 2830, a storage 2840, and a communication device 2860.

[0099] The input devices 2820 may be any suitable device that provides input, such as a touch screen or monitor, a keyboard, a mouse, or a voice recognition device. The output devices 2830 may be any suitable device that provides output, such as a touch screen, a monitor, a printer, a disk drive, or speakers.

[0100] Storage 2840 may be any suitable device providing storage, such as electrical, magnetic, or optical memory, including RAM, cache, hard drive, CD-ROM drive, tape drive, or removable storage disk. Communication device 2860 may include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or card. The components of a computer may be connected in any suitable manner, such as via a physical bus or wirelessly. Storage 2840 may be a non-transitory computer-readable storage medium containing one or more programs that, when executed by one or more processors, such as processor 2810, cause the one or more processors to perform a method described herein, such as all or a portion of method 200 and method 300 described above with respect to FIGS. 2 and 3.

[0101] The software 2850 that may be stored in the storage 2840 and executed by the processor 2810 may include, for example, programming embodying functionality of the present disclosure (e.g., as embodied in the systems, computers, servers, and / or devices described above). In some embodiments, the software 2850 may be implemented and executed on a combination of servers, such as an application server and a database server. The software may also include artificial intelligence or machine learning features.

[0102] The software 2850 can also be stored and / or transferred within any computer-readable storage medium for use by or in association with an instruction execution system, apparatus, or device described above that can fetch and execute instructions associated with the software from the instruction execution system, apparatus, or device. In the context of the present disclosure, a computer-readable storage medium can be any medium, such as storage 2840, that can contain or store programming for use by or in association with an instruction execution system, apparatus, or device.

[0103] The software 2850 may also be propagated in any transport medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, that can fetch and execute instructions associated with the software from the instruction execution system, apparatus, or device. In the context of this disclosure, a transport medium may be any medium that can communicate, propagate, or transfer programming for use by or in connection with an instruction execution system, apparatus, or device. Transport-readable media may include, but are not limited to, electronic, magnetic, optical, electromagnetic, infrared wired or wireless transport media.

[0104] The computing system 2800 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be protected by any suitable security protocol. The network may be comprised of any suitable arrangement of network links capable of effecting transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0105] The computing system 2800 may implement any operating system suitable for operating on a network. The software 2850 may be written in any suitable programming language, such as C, C++, Java, Python, or blockchain. In various embodiments, application software embodying functionality of the present disclosure may be deployed in various configurations, such as, for example, in a client / server arrangement or via a web browser as a web-based application or web service.

[0106] Unless otherwise defined, all technical terms, designations, and other technical and scientific or specialized terms used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter belongs. In some cases, terms having a commonly understood meaning are defined herein for clarity and / or ready reference, and the inclusion of such definitions herein should not necessarily be construed as representing a substantial difference from what is commonly understood in the art.

[0107] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Also, as used herein, the term "and / or" is to be understood to refer to and encompass any and all possible combinations of one or more of the associated listed items. Furthermore, as used herein, the terms "includes," "including," "comprises," and / or "comprising" are to be understood to specify the presence of stated features, integers, steps, operations, elements, components, units, and / or units, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or combinations thereof.

[0108] The foregoing description has been described with reference to specific embodiments for purposes of illustration. However, the illustrative discussion above is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the above teachings. These embodiments have been chosen and described in order to best explain the principles of the technology and its practical application. In this way, those skilled in the art can best utilize the technology and various embodiments with various modifications as appropriate for the particular use contemplated.

[0109] Although the present disclosure and embodiments have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as falling within the scope of the present disclosure and embodiments as defined by the claims. Furthermore, those skilled in the art will understand that one or more (e.g., all) of the above-described components and features can be combined without departing from the scope of the present disclosure. Finally, the entire disclosures of the patents and publications mentioned in this application are incorporated herein by reference.

Claims

1. 1. A cell therapy suite comprising: receiving information comprising a library of cell therapy protocols for multiple combinations of multiple patient indications and multiple genes of interest (GOIs); receiving a request to treat a patient with a cell therapy based on a combination of the patient's indication and GOI; responsive to receiving the request to treat the patient with cell therapy, performing steps of a respective cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI. one or more processors configured to A cell therapy suite equipped with:

2. The cell therapy suite of claim 1 , wherein the received information is from a remote server location external to the cell therapy suite.

3. The cell therapy suite of claim 1 or 2, wherein the cell therapy suite comprises a cell processing device.

4. 4. The cell therapy suite of claim 3, wherein the information comprising the library of cell therapy protocols includes a plurality of operating conditions for the cell treatment device for the plurality of combinations of a plurality of patient indications and a plurality of GOIs.

5. Receiving the request to treat the patient with cell therapy based on the combination of the patient's indication and GOI includes receiving a request for operating conditions of the cell treatment device based on the combination of the patient's indication and GOI. The cell therapy suite of claim 4.

6. 6. The cell therapy suite of claim 5, wherein, upon receiving the request for the operating conditions, the one or more processors are configured to process the patient's cells having RNA carrying the GOI in the cell treatment device according to the respective operating conditions corresponding to the combination of the patient's indication and GOI.

7. The cell therapy suite of claim 6, wherein the RNA is c-srRNA.

8. 10. The cell therapy suite of claim 1, wherein the one or more processors are configured to receive modifications to the library of cell therapy protocols for multiple combinations of multiple patient indications and multiple GOIs.

9. 10. The cell therapy suite of claim 1, wherein the cell therapy suite is a clean room that meets ISO 5, ISO 7, or ISO 8 standards.

10. RNA generation unit configured to load multiple GOIs onto RNA vehicles The cell therapy suite of claim 1 further comprising:

11. 11. The cell therapy suite of claim 10, wherein the one or more processors are configured to receive the patient's GOI identified by a sequencer, and in response to receiving the patient's identified GOI, load the identified GOI onto an RNA vehicle in an RNA generation unit, or the one or more processors are configured to transmit the identified GOI information to a remote server location outside the cell therapy suite.

12. The cell therapy suite of claim 1 , further comprising a sequencer for identifying a GOI for the patient.

13. 10. The cell therapy suite of claim 1, further comprising an apheresis device for extracting cells from the patient.

14. 10. The cell therapy suite of claim 1, wherein the information comprising the library of cell therapy protocols includes instructions on how to perform steps of each cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient indication and GOI.

15. The cell therapy suite of claim 14, wherein, in response to receiving the request to treat the patient with cell therapy, the one or more processors are configured to display the instructions on how to perform steps of each cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI.

16. 16. The cell therapy suite of claim 15, wherein the instructions are displayed on a heads-up display.

17. The cell therapy suite of claim 1 , further comprising an imaging device configured to capture an image of the cell therapy suite.

18. A cell therapy suite as described in claim 17, wherein the imaging device captures an image of the cell therapy suite in response to receiving the request to treat the patient with cell therapy.

19. 20. The cell therapy suite of claim 18, wherein the imaging device is a component of a heads-up display.

20. 1. A system for cell therapy treatment, comprising: Cell therapy suite and; one or more processors, receiving information comprising a library of cell therapy protocols for multiple combinations of multiple patient indications and multiple genes of interest (GOIs); receiving a request to treat a patient with a cell therapy based on a combination of the patient's indication and GOI; In response to receiving the request to treat the patient with cell therapy, performing steps of a respective cell therapy protocol from a library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI. one or more processors configured to A system comprising:

21. A method of operating a cell therapy system, the method being performed in a system comprising a cell therapy suite and one or more processors; receiving information comprising a library of cell therapy protocols for multiple combinations of multiple patient indications and multiple genes of interest (GOIs); receiving a request to treat a patient with a cell therapy based on a combination of the patient's indication and GOI; responsive to receiving a request to treat the patient with a cell therapy, performing steps of a respective cell therapy protocol from the library of cell therapy protocols corresponding to the combination of indication and GOI for the patient; Including, how to operate.

22. a non-transitory computer-readable medium storing cell therapy instructions, the instructions configured to be executed by one or more processors of a system comprising a cell therapy suite; The instructions may be executed to cause the system to: receiving information comprising a library of cell therapy protocols for multiple combinations of multiple patient indications and multiple genes of interest (GOIs); receiving a request to treat a patient with a cell therapy based on a combination of the patient's indication and GOI; responsive to receiving the request to treat the patient with cell therapy, performing steps of a respective cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI.

1. A non-transitory computer-readable medium configured to:

23. 1. A system for cell therapy treatment, comprising: one or more processors, receiving cell therapy protocols for patient indications and multiple gene of interest (GOI) combinations; responsive to receiving the cell therapy protocol, displaying instructions on how to perform a first step of the cell therapy protocol; determining whether the first step of the cell therapy protocol is complete; and displaying instructions on how to perform a second step of the cell therapy protocol in response to determining whether the first step of the cell therapy protocol is complete. and one or more processors configured to:

24. 24. The system of claim 23, further comprising a heads-up display (HUD), wherein the instructions on how to perform the first step of the cell therapy protocol are displayed on the HUD.

25. 25. The system of claim 24, wherein the HUD is an augmented reality HUD and the instructions on how to perform the first step of the cell therapy protocol are overlaid on components of a cell therapy suite.

26. 26. The system of claim 25, wherein the instructions on how to perform the first step of the cell therapy protocol identify the components of the cell therapy suite to be used in the first step of the cell therapy protocol.

27. 25. The system of claim 24, wherein the HUD is a virtual reality HUD and the instructions on how to perform the first step of the cell therapy protocol comprise a simulated cell therapy suite.

28. 25. The system of claim 24, wherein the HUD comprises an image capture device, and in response to receiving the cell therapy protocol, the image capture device captures an image of a cell therapy suite.

29. 29. The system of any one of claims 23-28, wherein determining whether the first step of the cell therapy protocol is complete comprises receiving user input indicating that the first step of the cell therapy protocol is complete.

30. 24. The system of claim 23, wherein determining whether the first step of the cell therapy protocol is completed comprises determining whether a user performs a gesture corresponding to the first step of the cell therapy protocol.

31. 24. The system of claim 23, wherein, in response to receiving the cell therapy protocol, the system provides auditory instructions on how to perform the first step of the cell therapy protocol.

32. 24. The system of claim 23, wherein the system provides auditory or tactile feedback in response to determining whether the first step of the cell therapy protocol is complete.

33. A method of operating a cell therapy system, the method being performed in a system having one or more processors, receiving information including a cell therapy protocol for a patient indication and a gene of interest (GOI) combination; responsive to receiving the cell therapy protocol, displaying instructions on how to perform a first step of the cell therapy protocol; making a determination whether the first step of the cell therapy protocol is complete; and displaying instructions on how to perform a second step of the cell therapy protocol in response to determining whether the first step of the cell therapy protocol is complete.

34. 1. A non-transitory computer-readable medium storing cell therapy instructions, the instructions configured to be executed by one or more processors, the execution of the instructions causing a system to: receiving a cell therapy protocol for a patient indication and gene of interest (GOI) combination; responsive to receiving the cell therapy protocol, displaying instructions on how to perform a first step of the cell therapy protocol; determining whether the first step of the cell therapy protocol is complete; and displaying instructions on how to perform a second step of the cell therapy protocol in response to determining whether the first step of the cell therapy protocol is complete. It is configured as follows: Non-transitory computer-readable medium.

35. 1. A system for cell therapy treatment, comprising: Cell therapy suite and; one or more processors, receiving a cell therapy protocol for a patient indication and gene of interest (GOI) combination; capturing an image of the cell therapy suite and / or patient in response to receiving the cell therapy protocol; transmitting images of the cell therapy suite and / or patient from the cell therapy suite to a remote location; receiving instructions on how to perform steps of the cell therapy protocol in response to transmitting the image of the cell therapy suite; and one or more processors configured to:

36. 36. The system of claim 35, wherein the instructions on how to perform the steps of the cell therapy protocol are from the location outside the cell therapy suite.

37. 37. The system of claim 36, wherein the instructions on how to perform the steps of the cell therapy protocol come from a remote operator viewing the images of the cell therapy suite and / or patient at the location outside the cell therapy suite.

38. 38. The system of any one of claims 35-37, wherein the image of the cell therapy suite comprises component identifiers for components of the cell therapy suite, and the instructions on how to perform steps of the cell therapy protocol comprise instructions on how to operate the components of the cell therapy suite.

39. 39. The system of claim 38, wherein the component identifier is a QR code or a barcode corresponding to the component of the cell therapy suite.

40. 36. The system of claim 35, wherein the image of the cell therapy suite and / or patient is a video of the cell therapy suite.

41. 36. The system of claim 35, wherein the one or more processors are configured to, in response to receiving instructions on how to perform steps of the cell therapy protocol, cause the display of the instructions on how to perform the steps of the cell therapy protocol.

42. 42. The system of claim 41, further comprising a heads-up display (HUD), wherein the instructions on how to perform the first step of the cell therapy protocol are displayed on the HUD.

43. 43. The system of claim 42, wherein the HUD is an augmented reality HUD and the instructions on how to perform the steps of the cell therapy protocol are overlaid on components of the cell therapy suite.

44. A method of operating a cell therapy system, the method being performed in a system comprising a cell therapy suite and one or more processors, receiving a cell therapy protocol for a patient's indication and gene of interest (GOI) combination; In response to receiving the cell therapy protocol, the cell therapy suite and a patient image are Capturing and; transmitting the images of the cell therapy suite and the patient from the cell therapy suite to a remote location; receiving instructions on how to perform steps of the cell therapy protocol in response to transmitting the image of the cell therapy suite.

45. 1. A non-transitory computer-readable medium storing cell therapy instructions, the instructions configured to be executed by one or more processors of a system comprising a cell therapy suite, the execution of the instructions causing the system to: receiving a cell therapy protocol for a patient indication and gene of interest (GOI) combination; capturing an image of the cell therapy suite and the patient in response to receiving the cell therapy protocol; transmitting the images of the cell therapy suite and the patient from the cell therapy suite to a remote location; receiving instructions on how to perform steps of the cell therapy protocol in response to transmitting the image of the cell therapy suite; It is configured as follows: Non-transitory computer-readable medium.

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