Method for controlling the treatment of biomaterial

Abstract

The invention discloses a method for controlling biological material treatment. The method comprises the steps of: receiving status information of a biological material and identification information identifying a smart contract associated with the biological material from a first device of a plurality of devices, an apparatus associated with a user interface for inputting data related to the biological material, or a biological material packaging apparatus; querying a distributed account book to retrieve a current state of the smart contract associated with the material; querying a data storage position of a non-secure distributed account book; retrieving an executable instruction; executing the instructions to process the state information, the processing including: verifying the state information and determining a portion of the state information to be stored on the distributed ledger; the determined partial state information is stored, and the state of the intelligent contract is updated.

Description

Technical Field

[0001] The present disclosure relates to a method for controlling the processing of biological materials. More particularly, the present disclosure relates to a method for controlling the processing of biological materials by a plurality of biological material processing devices. Background Art

[0002] Biological materials are collected for a variety of purposes, including but not limited to medical treatments, procedures, diagnostics, and research. Depending on the purpose for which the material was collected, the material may undergo multiple processing steps, which may include, among other things, shipping, handling, and preserving the biological material. For example, when the biological material includes cells (e.g., a blood sample), processing of the biological material may include isolation, differentiation, or expansion of the cells. Given this, it is important to identify the source of the biological material, e.g., human patient or animal subject, at each processing step.

[0003] For example, in the field of personalized and precision medicine (such as cell and gene therapy), biological materials can be collected from patients or donors, transported to processing facilities, where they are processed into therapeutic products and then shipped to patients. If it is not possible to handle or process them within a single facility, the biological materials may need to be transported between multiple facilities. In some application scenarios, due to factors such as sample characteristics and / or the geographical distance between the collection point, processing facility and administration point, the sample may need to be refrigerated or frozen to ensure that the activity of the biological material is not compromised during storage and transportation. In addition, due to the personalized nature of such treatments, a high degree of confidence in the chain of custody, identification and handling processes associated with the biological material may be important. While these goals may be easily achievable at a clinical scale, challenges may arise at a commercial scale because errors in identification and handling are more likely to occur and may go undetected.

[0004] It would be desirable to address or ameliorate one or more disadvantages or limitations associated with the prior art, or at least provide a useful alternative. Summary of the Invention

[0005] According to at least one embodiment of the present invention, a method for controlling the processing of biomaterials by a plurality of biomaterial processing devices is provided. The method is implemented by a processor executing computer program instructions stored in a memory, and includes the following steps: From one of the following: a first device of the plurality of devices, a device associated with a user interface for inputting data related to biological material, and Biomaterial packaging equipment, receiving status information of a biomaterial and identification information identifying a smart contract associated with the biomaterial; using the identification information to query a cryptographically secure distributed ledger to retrieve the smart contract associated with the biomaterial, including a current state of the smart contract; Based on the retrieved smart contract and the current state of the smart contract, querying a data storage location to retrieve executable instructions, wherein the data storage location is a non-secure distributed ledger; Execution of the executable instructions causes the processor to at least: processing the state information, wherein the processing comprises: verifying the status information, and determining a portion of the state information to be stored on the distributed ledger; and Writing to said distributed ledger to: storing the determined portion of the state information, and Updating the state of the smart contract.

[0006] According to at least a further embodiment of the present invention, there is also provided a method for controlling the processing of extracted biological material from its initial extraction to its final use, the processing involving multiple stages, the method comprising performing the above method at each of several of the multiple stages.

[0007] According to at least another embodiment of the present invention, a system for controlling biological material processing is provided, comprising a plurality of biological material processing devices, a coordination system, a cryptographically secure distributed ledger, and a data storage location. The coordination system comprises a processor for executing computer program instructions and a memory storing the computer program instructions executed by the processor. The cryptographically secure distributed ledger stores smart contracts associated with the biological material. The data storage location is a non-secure distributed ledger that stores retrievable computer-executable instructions. The computer program instructions stored in the memory include instructions that, when executed by the processor, cause the coordination system to: Receive status information of the biomaterial and identification information identifying the smart contract from one of the following: a first device of the plurality of devices, a device associated with a user interface for inputting data related to the biological material, and Biomaterial packaging equipment, querying a distributed ledger using the identification information to retrieve the smart contract and the current state of the smart contract; and A data storage location may be queried based on the smart contract and the current state to retrieve computer-executable instructions. The computer-executable instructions stored in the data storage location may include instructions that, when executed by the processor, cause the coordination system to: processing the state information by validating the state information and determining a portion of the state information to store on the distributed ledger; and Writing to the distributed ledger to store the determined portion of the state information and update the state of the smart contract.

[0008] According to at least another embodiment of the present invention, there is also provided a coordination system for controlling biological material processing, the coordination system comprising: at least one processor; and A memory storing computer program instructions which, when executed by at least one processor, cause the coordination system to perform the above method.

[0009] According to the present invention, there is also provided a non-transitory machine-readable storage medium having computer program instructions which, when executed by at least one processor of the coordination system, cause the coordination system to perform the above method. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Some embodiments of the invention are described below, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0011] Figure 1 is a schematic diagram illustrating an embodiment of a system for controlling processing of biomaterials by a plurality of biomaterial processing devices;

[0012] Figure 2 is a schematic diagram illustrating components of an embodiment of a biological material processing apparatus;

[0013] Figure 3 is a schematic diagram illustrating components of an embodiment of a packaging apparatus;

[0014] Figure 4 is a flow chart illustrating an embodiment of a method for controlling the processing of biomaterial by one or more biomaterial processing devices.

[0015] Figure 5 is a flow chart illustrating steps that may be included in some embodiments of a method involving receiving historical state information and historical identification information.

[0016] Figure 6 is a flow chart illustrating steps that may be included in some embodiments of a method involving receiving historical state information and historical identification information.

[0017] Figures 7 to 9 is a schematic diagram illustrating an example of a coordination system that receives and processes status information and identifies subsequent sub-processes to execute.

[0018] Figures 10 to 29is a flow chart illustrating the milestones and sub-processes of a smart contract for controlling the processing of biomaterials for CAR-T therapy. Detailed description

[0019] In at least some embodiments, the present invention may provide a system and method for controlling the processing of biological material by one or more of a plurality of biological material processing devices.

[0020] Figure 1 An embodiment of a system 100 for controlling the processing of biological material by a plurality of biological material processing devices 102 is shown. As shown, the devices 102 include a first device 104 and a second device 106. The system 100 includes a coordination system 108, a distributed ledger 110, an input device 112, a data storage location 114, and a data lake 128. Coordinated system

[0021] Coordination system 108 is a computing system that includes memory 118 and at least one processor 120. Coordination system 108 coordinates the processing of biological materials. To this end, coordination system 108 is configured to communicate with distributed ledger 110, input device 112, data storage location 114, data lake 128, each of the plurality of devices 102, and at least one packaging device 126. Input devices

[0022] Input device 112 is configured to receive data related to the biomaterial and transmit the data to coordination system 108. Input device 112 is associated with user interface 116 through which device 112 can receive user input of data related to the biomaterial, such as input from a medical professional. Distributed ledger

[0023] The distributed ledger 110 includes a plurality of distributed nodes 122. The nodes 122 are organized into a peer-to-peer network, wherein each node 122 can connect to one or more other nodes 122 using a peer-to-peer communication protocol. The connection configuration between the nodes 122 may change over time, and at any given point in time, the nodes forming part of the network communicate using the peer-to-peer protocol. At least one of the nodes 122 is connected to the coordination system 108. The distributed ledger 110 is preferably a secure distributed ledger, and more preferably a cryptographically secure distributed ledger. Preferably, the distributed ledger 110 is a decentralized distributed ledger. The distributed ledger 110 can be a public distributed ledger or a private distributed ledger. Using a private distributed ledger can allow one or more biological material processing devices to host at least one node 122 of the distributed ledger 110, as described herein. In embodiments, the distributed ledger 110 can be a blockchain network (also referred to as a "blockchain"), such as a private blockchain network. In embodiments, the distributed ledger 110 can include (at least in part) a public blockchain network.

[0024] Coordination system 108 is configured to write information to distributed ledger 110 to store information, including storing information representative of or derived from the information stored to distributed ledger 110. When this specification refers to writing information to a distributed ledger, it should be interpreted to include writing the information to the distributed ledger, or writing any information representative of or derived from the information to the distributed ledger. Smart Contracts

[0025] Among other things, the distributed ledger 110 stores one or more smart contract templates 123 related to processing biomaterials. Each smart contract template 123 defines executable logic that can be executed by the coordination system 108. The executable logic of a given smart contract template 123 defines a set of rules in the form of milestones and corresponding sub-processes related to biomaterials. Each smart contract template 123 can correspond to a corresponding type or category of biomaterials and / or a process related to a type or category of biomaterials. For example, a particular template 123 can correspond to a CAR-T cell therapy (wherein the biomaterial includes peripheral blood mononuclear cells) or an assisted reproductive therapy (wherein the biomaterial can include sperm, eggs, or embryos), or any other process or therapy involving the use of biomaterials (which can include, but is not limited to, extracted biomaterials and biomaterial samples). Each template 123 stored on the distributed network 110 can be associated with a corresponding unique identifier ("template identifier").

[0026] The distributed ledger 110 also stores one or more smart contracts 124, each of which is an instance of a smart contract template 123. In response to user input, a smart contract 124 is initialized on the distributed ledger 110 using the associated template 123. The user input indicates a desired smart contract template 123 to be used to initialize the smart contract 124. The coordination system 108 receives the user input (e.g., via an input device 112 as described herein) and, in response, sends a request to the distributed ledger 110 to initialize and store the smart contract 124 using the associated template 123. The coordination system 108 may assign a unique identifier ("smart contract identifier") to the initialized smart contract 124, which is stored on the distributed ledger 110 along with the smart contract 124.

[0027] By processing the smart contract 124 generated based on the template 123 (i.e., the smart contract instance 124 generated from the smart contract template 123), the coordination system 108 can maintain data records related to the biological material and control the operation of the relevant devices 102 to process the biological material, for example, for storage, transportation, processing, etc. To control the relevant devices 102, the coordination system 108 can determine one or more commands or computer-executable instructions and transmit these commands or executable instructions to each of the plurality of devices 102. Biological material processing equipment

[0028] Each of the plurality of devices 102 is a biological material processing device. Exemplary biological material processing devices include, but are not limited to, cryopreservation devices for cryopreserving biological materials by cooling to extremely low temperatures (suitable temperatures, which may include temperatures below the liquid-to-solid phase transition temperature), thawing devices for thawing biological materials (e.g., cryopreserved biological materials), transport devices for transporting biological materials under controlled conditions (e.g., transport devices configured to transport biological materials using drones or under temperature-controlled conditions), storage devices for storing biological materials under controlled conditions, bioreactor devices, and analytical devices (e.g., cell counting devices and in vitro diagnostic devices for determining the number and / or type of cells present in biological materials).

[0029] The components of the exemplary biological material processing apparatus 200 are Figure 2Schematically represented in FIG. Apparatus 200 includes a processor 202, a communications module 204, a data store 206, and one or more sensors 208 (three sensors are depicted by way of example only). Processor 202 controls the operation of apparatus 200 and is configured to execute applications that manage the collection, processing, storage (to data store 206), and transmission of data received from any sensor 208. Processor 202 generates status information related to the operation performed by apparatus 200 on biological material processed by apparatus 200, which is transmitted to coordination system 108 by communications module 204.

[0030] The status information may include monitoring information of the biological material. The monitoring information may include, for example, at least one of temperature monitoring information related to the current temperature of the biological material, position monitoring information related to the current position of the biological material, volume monitoring information related to the volume of the biological material, and cell count information related to the number of cells associated with the biological material.

[0031] Communication module 204 facilitates communication between device 200 and coordination system 108 via at least one network, which may be a local area network (LAN) (e.g., an Ethernet or Wi-Fi network), a wide area network (WAN) (e.g., a 4G or 5G cellular network), or a personal area network (PAN) (which may include Bluetooth, ZigBee, Thread, Matter, Z-Wave, RFID, or Wireless USB, or other short-range or mesh communication systems). In this regard, coordination system 108 can be configured to communicate with each of the plurality of devices 102 via the mesh network. Coordination system 108 can also be configured to communicate directly with each of the plurality of devices 102. When communication is at least partially performed using the mesh network, at least some of the devices 102 can also communicate directly with each other using their respective communication modules 204. Data communicated between device 200 and coordination system 108 via communication module 204 can be encrypted. Communication module 204 can transmit data to coordination system 108 using an application programming interface (API) and a unique API key generated for device 200. Communication module 204 may also transmit data to coordination system 108 by writing directly to an open communication port of coordination system 108 or by any other suitable (and preferably secure) means.

[0032] Each sensor 208 captures sensor data related to the biological material being processed by the device 200. For example, a given sensor 208 may be one of the following (although a given sensor configuration may depend on the device): a) a temperature sensor for monitoring the temperature of the biological material processed by the apparatus 200; b) a position sensor for monitoring the position of the biological material being processed by the apparatus 200; c) a volume sensor for monitoring the volume of biological material processed by the apparatus 200; and d) A cell counting sensor for monitoring the cell count of the biological material processed by the apparatus 200 .

[0033] Any other suitable sensors may be included in the biomaterial processing apparatus 200 .

[0034] Processor 202 collects and processes sensor data received from each sensor 208 to generate status information (including monitoring information), which can be transmitted to coordination system 108 via communication module 204 .

[0035] Processor 202 may store the generated state information (including monitoring information) in data storage 206 of device 200. This may be in addition to transmitting the state information to coordination system 108 using communication module 204, so that the stored data can be referenced later, for example, for data integrity or recovery purposes. State information may also be stored in data storage 206 and then transmitted to coordination system 108 using communication module 204, for example, when coordination module 204 is temporarily unable to communicate with coordination system 108 via at least one network (e.g., due to a temporary disconnection from the network).

[0036] Thus, in data storage 206, device 200 can maintain a local database of information generated by device 200. The state information stored in data storage 206 can be referred to as historical state information. The historical state information can also be transmitted to coordination system 108 by communication module 204. Maintenance of this local database can assist with data capture coordination, data integrity, and data recovery.

[0037] Each device 200 may be associated with a unique identifier ("device identifier"). As further described herein, the device identifier may be used when transmitting state information from the device 200 to the coordination system 108 to allow the coordination system 108 to identify the source of the information.

[0038] In some embodiments, at least one of the plurality of devices 102 is configured to host at least one node 122 of the distributed ledger 110. Thus, the distributed ledger 110 can utilize idle processing capacity within one or more devices. The coordination system 108 can be configured to determine whether the device has sufficient processing and storage capacity to host at least one node 122 of the distributed ledger. The coordination system 108 can also ensure that the device also has sufficient processing and storage capacity to perform primary functions, such as controlling the operation of the device to process biological material in addition to serving as a node. For example, the coordination system 108 can determine whether the device has sufficient processing and storage capacity to host at least one node 122 based on status information received from the device in the form of operational monitoring information. The operational monitoring information can include the device's instantaneous and / or historical CPU utilization, memory usage, and storage utilization. The operational monitoring information can be received from the device periodically, for example, every 10 seconds.

[0039] If coordination system 108 determines that the device has sufficient processing and storage capacity to host the at least one node 122 without compromising its ability to process biological material, coordination system 108 may allow the device to host the at least one node 122, e.g., by transmitting an instruction to the device to host the at least one node 122. Once the device is hosting the at least one node 122, if coordination system 108 determines that the device no longer has sufficient processing and storage capacity to host the at least one node 122 without compromising its ability to process biological material (a determination that may be made based on received operational monitoring information), coordination system 108 may disable the device from hosting the at least one node 122, e.g., by transmitting an instruction to the device to stop hosting the at least one node 122. Data storage locations and data lakes

[0040] exist Figure 1 In the illustrated system 100 , the data storage location 114 stores executable instructions that, when executed by the coordination system 108 , cause the processor 120 of the coordination system 108 to at least perform the following operations: (i) processing the state information, the processing including validating the state information and determining a portion (or portions) of the state information to store on the distributed ledger 110; (ii) writing to the distributed ledger 110 to store a portion (or portions) of the determined state information; and (iii) Writing to the distributed ledger 110 to update the state of the smart contract 124.

[0041] Authorized administrators can edit and add executable instructions stored in data storage location 114 at any time. While executable instructions are retrieved and executed according to smart contract 124, they do not need to be submitted to distributed ledger 110. This allows executable instructions to be more easily modified by authorized administrators who have access to data storage location 114 but may not have access to distributed ledger 110. Furthermore, when distributed ledger 110 is an immutable distributed ledger (e.g., a blockchain network), storing executable instructions in data storage location 114 rather than distributed ledger 110 can avoid the need to immutably submit executable instructions to distributed ledger 110 and the associated computing / storage resources required in the event that any executable instructions need to be modified. In this regard, if executable instructions were to be stored on distributed ledger 110, each node 122 would need to maintain a separate copy of the executable instructions. Furthermore, any modification to executable instructions stored on distributed ledger 110 would require distributed ledger 110 to ensure consensus among nodes 122, for example, by nodes 122 executing a consensus protocol. Furthermore, if executable instructions are immutably committed to distributed ledger 110, any modification to the executable instructions stored on the distributed ledger would require storing both the modified executable instructions and the original executable instructions on distributed ledger 110. However, because the executable instructions are stored in data storage location 114, only a single record of the executable instructions is required, and the data does not need to be maintained in multiple locations. Data storage location 114 also does not need to execute consensus protocols, etc., when modifications are made to the executable instructions. At the same time, the security of the executable instructions stored in data storage location 114 can still be maintained, for example, by requiring special permissions to modify the data stored in data storage location 114.

[0042] Coordination system 108 may query data storage location 114 to retrieve executable instructions stored therein.

[0043] Data lake 128 is a data storage location in which coordination system 108 stores state information and identification information received from any of input device 112, multiple apparatuses 102, and packaging device 126. Coordination system 108 may also store data generated by it when executing executable instructions retrieved from data storage location 114 in data lake 128.

[0044] Data storage location 114 and data lake 128 may each include any suitable data storage mechanism, such as local data storage, cloud storage, or a distributed file system (DFS) (e.g., InterPlanetary File System (IPFS)). Figure 1 The data storage location 114 and the data lake 128 are shown separately, but the data storage location 114 and the data lake 128 may be a single data storage location. Packaging equipment

[0045] The packaging device 126 is used to receive and hold biological material, such as when the biological material is being processed, stored, and / or transported to any of the plurality of devices 102. For particularly sensitive biological material, the packaging device 126 can be configured to store, preserve, and / or thaw the biological material contained within the packaging device 126. For example, the packaging device 126 can be configured to hold the biological material while it is being preserved, cooled, or thawed by one of the plurality of devices 102. The packaging device 126 can include an RFID tag that stores identification information of the packaging device 126. The packaging device 126 can include one or more thermal profiles, wherein, during use, the biological material is distributed between subcompartments of the packaging device 126, and the flow of a heat exchange fluid can be directed by the thermal profiles to improve heat transfer between the heat exchange fluid and the biological material contained in the subcompartments. An example of a suitable packaging device is described in Australian Provisional Application No. 2021904254, the entire disclosure of which is incorporated herein by reference.

[0046] Figure 3 Components of an exemplary packaging device 126 are schematically shown in FIG. Packaging device 300 includes a processor 302, a communication module 304, a data storage device 306, and one or more sensors 308 (three sensors are depicted by way of example only). Communication module 304 facilitates communication between packaging device 126 and coordination system 108 via at least one network (e.g., a LAN and / or WAN as described with respect to communication module 204 of biological material processing apparatus 200). Data transmitted between packaging device 126 and coordination system 108 via communication module 304 can be encrypted. Communication module 304 can transmit data to coordination system 108 using an application programming interface (API) and a unique API key generated for packaging device 126.

[0047] Each sensor 308 captures sensor data related to the biological material stored by the packaging device 126. For example, a given sensor 308 may be one of the following: e) a temperature sensor for monitoring the temperature of the biological material stored in the packaging device 126; f) a position sensor for monitoring the position of the biological material stored by the packaging device 126; g) a volume sensor for monitoring the volume of biological material stored in the packaging device 126; h) a cell counting sensor for monitoring the cell count of biological material stored by the packaging device 126; i) A shock sensor for monitoring shocks to the packaging equipment 126 .

[0048] The processor 302 collects and processes the sensor data received from each sensor 308 to generate status information in the form of monitoring information, which can be transmitted to the coordination system 108 via the communication module 304 .

[0049] Similar to apparatus 200 described above, processor 302 may store the generated monitoring information in data storage 306 of packaging device 126 so that the stored data can be referenced later, for example, for data integrity or recovery purposes. Thus, packaging device 126 may maintain a local database of information generated by packaging device 126 in data storage 306. The monitoring information stored in data storage 306 may be referred to as historical monitoring information. This historical monitoring information may also be transmitted to coordination system 108 via communication module 304. Maintaining this local database may facilitate data capture coordination, data integrity, and data recovery. Biomaterials and applications

[0050] Biomaterials may include one or more of the following: a) whole blood; b) blood components, such as platelets, red blood cells, white blood cells, plasma and other blood products; c) stem cells, such as hematopoietic stem cells, mesenchymal stem cells and embryonic stem cells; d) modifying cells; e) Engineered cells f) gametes, such as eggs and sperm; g) embryonic cells h) oocyte; i) organs, including parts thereof; and j) Organization.

[0051] It should be understood that the examples of biological materials identified herein are not an exhaustive list and that the packaging may be used to store other biological materials as well.

[0052] The systems and methods described herein can be used to control the processing of biological materials for various purposes. For example, the systems and methods can be used to control the processing of biological materials for therapeutics and cell therapies. method

[0053] Figure 4 is a flow chart illustrating an embodiment of a method 400 for controlling the processing of biological material by a plurality of biological material processing devices. In this embodiment, the method 400 is implemented by the processor 120 of the coordination system 108. The method 400 begins at step 402.

[0054] At step 402, coordination system 108 receives status information of the biomaterial and identification information identifying the biomaterial. The status information and identification information are received from at least one of: first device 104 of plurality of devices 102, input device 112 associated with user interface 116, and biomaterial packaging device 126.

[0055] The identification information uniquely identifies a smart contract stored on the distributed ledger 110 corresponding to the biomaterial to be processed by the plurality of devices 102 (i.e., a specific instance of the biomaterial), and the intended use or application of the biomaterial, such as chimeric antigen receptor T cell (CAR-T cell) therapy for leukocytes or ART therapy for sperm assisted reproductive technology. The identification information may include or correspond to a smart contract identifier of the associated smart contract.

[0056] The identification information may be generated by the coordination system 108 based on user input received from the user interface 116 via the input device 112 , indicating that a new process, and therefore a new smart contract, is to be initiated.

[0057] Status information includes information received by coordination system 108 that is related to the processing of biological material but is not identification information. For example, status information may include information indicating the status of biological material to be processed by multiple devices 102. Status information may include information such as the volume of the biological material (e.g., mL or number of cells) and the quality of the biological material. For example, if the biological material is sperm, the status information may indicate the volume, motility, and / or grade of the sperm. Status information may include information indicating the status of one or more devices 102 processing the biological material.

[0058] The coordination system 108 can identify the specific smart contract 124 among all smart contracts 124 stored on the distributed ledger 110 that needs to coordinate the relevant biological material processing by examining the received identification and status information.

[0059] In some embodiments, coordination system 108 stores the received state information in data lake 128. Coordination system 108 can store the received state information and its associated identification information in data lake 128 so that the state information of a particular smart contract 124 can be subsequently retrieved from data lake 128 as needed.

[0060] At step 404, coordination system 108 queries distributed ledger 110 to receive the smart contract 124 determined to be needed. The query uses the identification information received at step 402. At step 406, in response to the query, coordination system 108 retrieves the identified smart contract 124 from distributed ledger 110. The retrieved smart contract 124 is associated with the biomaterial via the identification information and includes a current state of the smart contract 124. The current state of the smart contract 124 indicates the "current" milestone and / or subprocess defined by the smart contract 124 that is currently occurring or will occur next with respect to the associated biomaterial.

[0061] In some embodiments, the identification information includes a smart contract identifier of the desired smart contract, which coordination system 108 can use to query distributed ledger 110 to obtain the desired smart contract 124, as described above.

[0062] Once the coordination system 108 retrieves the smart contract associated with the smart contract identifier, including the current state of the smart contract 124, at step 408, the coordination system 108 uses the smart contract 124 and the current state of the smart contract 114 to query the data storage location 114 to retrieve executable instructions that define how the current milestone or process (determined by the current state of the smart contract 124) is to be executed by the coordination system 108.

[0063] At step 410 , coordination system 108 receives executable instructions from data storage location 114 in response to the query at step 408 .

[0064] At step 412 , the coordination system 108 executes the retrieved executable instructions to execute the current milestone or sub-process. In this regard, the execution of the executable instructions causes the processor 120 of the coordination system 108 to at least process the received state information and write it to the distributed ledger 110 .

[0065] Processing the state information in step 412 may include validation of the state information. Validation includes evaluating the state information to determine whether it meets one or more requirements of the current milestone or sub-process. This may include, for example, determining whether the state information meets a required threshold for the state information or is within a required range for the state information, where the threshold or range is defined by the executable instructions.

[0066] Processing the state information in step 412 may include determining a portion or portions of the state information to be stored on distributed ledger 110. This processing may determine the need to store all or a portion of the state information on distributed ledger 110 based on the content and / or characteristics of the state information. For example, if the state information includes temperature monitoring information with temperature measurements taken every second, processing the state information may include determining to store only one temperature measurement on distributed ledger 110 every 60 seconds unless the difference between consecutive temperature measurements exceeds a predetermined threshold. This may reduce the amount of data and associated computing resources required to be stored on distributed ledger 110 while ensuring that relevant information is still submitted to the distributed ledger.

[0067] By executing the executable instructions, coordination system 108 may write to distributed ledger 110 to store the determined partial state information in distributed ledger 110 .

[0068] In some embodiments, writing the portion of state information to the distributed ledger may include submitting a write request to a gatekeeper component (not shown) associated with distributed ledger 110. The gatekeeper component may also be described as a "gateway" and is a component of distributed ledger 110 that manages interactions between coordination system 108 and distributed ledger 110, including requests from coordination system 108 to read data stored on distributed ledger 110 and requests to write data stored on distributed ledger 110.

[0069] The write request may include a portion of the state information and an associated smart contract identifier. In response to receiving the write request, the gatekeeper component may execute a process to transform the portion of the state information, e.g., to make it more suitable for storage on the distributed ledger 110, and store the transformed portion of the state information on the distributed ledger 110.

[0070] As described above, in some embodiments, the coordination system 108 can store state information in the data lake 128. Therefore, if only part of the state information is stored in the distributed ledger 110 according to the processing in step 412, the system 100 can still store the remaining state information in the data lake 128 (if necessary).

[0071] By executing the executable instructions, coordination system 108 writes to distributed ledger 110 to update the state of the smart contract. In this regard, by executing the executable instructions, coordination system 108 determines that the current milestone or sub-process (corresponding to the executable instructions) has been completed and determines the subsequent milestone or sub-process to be achieved. Coordination system 108 updates the current state of smart contract 124 on the distributed ledger by writing to the distributed ledger to store the new current state corresponding to the subsequent milestone or sub-process to be achieved. Therefore, when distributed ledger 110 is next queried for the current state of the smart contract, the updated current state will be returned.

[0072] Thus, while the executable instructions are retrieved and executed according to smart contract 124 stored on the distributed ledger, the executable instructions themselves are stored in data storage location 114 rather than distributed ledger 110. This means that the logic defined by the executable instructions does not need to be stored and maintained by distributed ledger 110, which can reduce the computing resources required by the distributed ledger. Furthermore, storing the executable instructions in data storage location 114 while the smart contract 124 is stored on distributed ledger 110 makes it easier to edit the executable instructions when needed.

[0073] According to embodiments of the method, the coordination system 108 may appropriately process and store received state information related to the plurality of processes and, therefore, the smart contracts.

[0074] In some embodiments, executing the executable instructions further causes processor 120 of coordination system 108 to determine one or more commands or one or more computer-executable instructions to be executed by second device 106 of multiple devices 102 and transmit these commands or computer-executable instructions to second device 106.

[0075] The commands or computer-executable instructions allow coordination system 108 to control the operation of second device 106 to process the biological material in a manner specified by the executable instructions executed by coordination system 108 .

[0076] In some embodiments, method 400 includes coordination system 108 receiving historical state information and historical identification information of a biological material, such as Figure 5 and Figure 6 As shown in steps 502 and 602 of FIG. Historical status information and historical identification information are received from at least one of the first device 104 and the packaging equipment 126. As described above, the coordination system 108, the device 102, and the packaging equipment 126 can be connected in a mesh network. When status and identification information is transmitted from the device 104, 106, or the packaging equipment 126 to the coordination system 108 via the mesh network, the status and identification information can be transmitted to the coordination system 108 via multiple communication paths. Therefore, the coordination system 108 can receive status and identification information multiple times.

[0077] If the coordination system 108 has previously received state and identification information corresponding to the historical state and identification information received at step 502 (or 602), then at step 504, the coordination system 108 determines whether the previously received state information should be updated using the historical identification information. This determination is made by comparing the historical state and identification information with the previously received state and identification information. If, based on the comparison, the coordination system 108 determines that the state and identification information has been received (i.e., it is consistent with the previously received state and identification information), then it is determined that the previously received state information should not be updated using the historical identification information. If, based on the comparison, the coordination system 108 determines that there is an inconsistency between the previously received state information and the historical identification information, then at step 506, the coordination system 108 updates the previously received state information by storing an additional entry on the distributed ledger 110 recording the historical state information and marking the inconsistency.

[0078] Coordination system 108 also uses the historical identification information to determine whether coordination system 108 has previously received status and identification information corresponding to the historical status and identification information from first device 104 and / or packaging equipment 126. If, in step 604, coordination system 108 determines that the historical status information has not been previously received, then, in step 406, coordination system 108 stores the historical status information on distributed ledger 110.

[0079] Thus, by receiving historical state and identification information from the first device 104 and / or packaging equipment 126, the coordination system 108 can identify any errors in previously received state information that may have been stored on the distributed ledger 110. The coordination system 108 can also identify any "missing" state information that should have been previously received and stored on the distributed ledger 110 but was not. The coordination system 108 can also avoid storing multiple copies of state and identification information that was received multiple times. Sub-process selection process

[0080] Figure 7 An example is shown of how the coordination system 108 receiving status information may result in selection of a subsequent sub-process, where the biological material is sperm collected from a patient for ART purposes.

[0081] In this example, the coordination system 108 receives input from an input device 112 in the form of state information, i.e., the amount of sperm in the collected sample. The input also includes identification information (e.g., a smart contract identifier) that allows the coordination system 108 to retrieve the relevant smart contract 126 corresponding to the current patient and ART process and the current state of the smart contract 126. In response to receiving the state information and identification information, the coordination system 108 uses the identification information to query the distributed ledger 110 to retrieve the smart contract 126 associated with the sperm collected from the patient, including the current state of the smart contract. After retrieval, the coordination system 108 uses the current state to query the data storage location 114 to retrieve executable instructions. The retrieved executable instructions are related to the current state of the smart contract 126. The coordination system 108 executes the retrieved executable instructions to cause the processor to (at least) process the state information and store at least a portion of the state information to the distributed ledger 110, as shown below.

[0082] By executing the executable instructions, coordination system 108 verifies the state information to determine whether the sperm volume has passed a transition condition (i.e., a threshold sperm volume). In this case, coordination system 108 determines that the transition condition has been met (i.e., a sufficient sperm volume). Coordination system 108 then determines that the current sub-process has been completed and queries distributed ledger 110 to determine the next sub-process to be implemented (i.e., the new "current state" of smart contract 126), which in this case includes multiple concurrent sub-processes determined to initiate temperature monitoring of the collected sample contained within packaging device 126 by determining and transmitting appropriate commands or computer-executable instructions to packaging device 126, notifying the relevant cryopreservation devices (of multiple devices 102) of the incoming biological material and its characteristics, and confirming compliance with regulatory standards.

[0083] Figure 8 Another example is shown illustrating how the coordination system 108 receiving status information may result in selection of a subsequent sub-process in one embodiment, where the biological material is sperm collected from a patient for ART purposes.

[0084] In this example, the coordination system 108 receives input from an input device 112 in the form of state information, namely, the sperm count and sperm motility of the collected sample. The input also includes identification information (which may include a smart contract identifier or a patient identifier, from which the coordination system 108 can derive the smart contract identifier), which allows the coordination system 108 to retrieve the relevant smart contract 126 corresponding to the current patient and ART process, as well as the current state of the smart contract 126. In response to receiving the state information and identification information, the coordination system 108 uses the identification information to query the distributed ledger 110 to retrieve the smart contract 126 associated with the sperm collected from the patient, including the current state of the smart contract. After retrieval, the coordination system 108 uses the current state to query the data storage location 114 to retrieve executable instructions. The retrieved executable instructions correspond to the current state of the smart contract 126. The coordination system 108 executes the retrieved executable instructions to cause the processor (at least) to process the state information and store it in the distributed ledger, as shown below.

[0085] By executing executable instructions, coordination system 108 validates the inputs to determine whether the sperm count and sperm motility meet respective transition conditions (i.e., threshold sperm count and sperm motility requirements). In this case, coordination system 108 determines that the transition conditions have not been met (i.e., both are not met), and therefore a second donation is required. Coordination system 108 then initiates temperature monitoring of the sperm and generates a request for an additional sample. Coordination system 108 transmits the request to input device 112, which presents the request to a user via user interface 116. Coordination system 108 then determines that because a second donation is required, the previous milestone (corresponding to sample collection) must be restarted, and determines that the next sub-processes to be implemented simultaneously are: the second donation (restarting the previous milestone), temperature monitoring of the collected sample, and notification of the incoming biological material and its characteristics to the relevant cryopreservation devices (of the plurality of devices 102).

[0086] Figure 9 A further example of how receipt of status information by the coordination system 108 may result in selection of a subsequent sub-process is shown where the biological material is sperm collected from a patient for ART.

[0087] In this example, the coordination system 108 receives input from the packaging device 126 in the form of state information, i.e., temperature monitoring information of the collected sample. The input also includes identification information (e.g., a smart contract identifier) that allows the coordination system 108 to retrieve the relevant smart contract 126 corresponding to the current patient and ART process, as well as the current state of the smart contract 126. In response to receiving the state information and identification information, the coordination system 108 uses the identification information to query the distributed ledger 110 to retrieve the smart contract 126 associated with the sperm collected from the patient, including the current state of the smart contract. Once retrieved, the coordination system 108 uses the current state to query the data storage location 114 to retrieve executable instructions. The retrieved executable instructions correspond to the current state of the smart contract 126. The coordination system 108 executes the retrieved executable instructions to cause the processor (at least) to process the state information and store it in the distributed ledger 110, as shown below.

[0088] By executing the executable instructions, the coordination system 108 verifies the status information to determine whether the temperature of the sample collected at the time of collection passes the transition condition (i.e., the acceptable temperature requirement) defined in the executable instructions. In this case, the coordination system 108 determines that the temperature monitoring information is acceptable (i.e., the transition condition has passed). The coordination system 108 then initiates temperature monitoring of the sperm contained in the packaging device 126 by determining an appropriate command or computer executable instruction and transmitting the command or computer executable instruction to the packaging device 126, and causes the temperature monitoring information to be stored in the data lake 128. The coordination system 108 determines at least a portion of the received temperature monitoring information (or data derived from the information) to be stored on the distributed ledger 110, and causes the portion of the temperature monitoring information to be stored on the distributed ledger 110. The coordination system 108 then determines that the next sub-process to be implemented simultaneously is to continue temperature monitoring of the collected samples and confirm compliance with regulatory standards. Example 1: CAR-T (Chimeric Antigen Receptor T Cell) Therapy

[0089] In a first example, the systems and methods described herein are used to control the processing of biomaterials for use in CAR-T therapy. In this example, the biomaterials include peripheral blood mononuclear cells ('PBMNCs'), which are genetically engineered to become CAR-T cells.

[0090] In this example, the distributed ledger is a private blockchain, but in other examples a public blockchain could be used.

[0091] Initially, user interface 116 receives user input requesting the initialization of a new process. This input indicates a desired smart contract template 123 to be used to initialize the smart contract for the current process. Coordination system 108 receives the user input via input device 112 and, based on the user input, is able to determine a template identifier corresponding to the desired smart contract template 123. Coordination system 108 then uses the template identifier to send a request to the blockchain to initialize smart contract 124. This request includes a smart contract identifier, which coordination system 108 generates to associate with the newly initialized smart contract and store with the smart contract on the blockchain.

[0092] In this example, the user input is a selection made by a physician indicating that they wish to initiate a CAR-T treatment procedure. From the received user input, coordination system 108 is able to identify a relevant template identifier corresponding to template 123 for a CAR-T treatment procedure. Coordination system 108 then uses the CAR-T treatment template identifier to send a request to the blockchain to initialize a new smart contract 124 for the CAR-T treatment. This involves generating a new smart contract identifier, which is sent along with the request to the blockchain and associated and stored with the newly initialized smart contract 124.

[0093] In this example, after initializing smart contract 124, coordination system 108 updates the current state of smart contract 124 to sub-process 1.1 of milestone 1. Updating the current state involves submitting a write request for a transaction associated with the current state of sub-process 1.1 to a gatekeeper component associated with the blockchain. The write request includes the smart contract identifier. In response to receiving the write request, the gatekeeper component executes a process to create a new entity transaction for the data and submits the entity transaction to the blockchain associated with smart contract 124 for the current CAR-T treatment process. Coordination system 108 then receives confirmation from the gatekeeper component that the current state has been stored on the blockchain. Milestone 1

[0094] like Figure 10 As shown, the first milestone of this example is "doctor-patient identity verification".

[0095] Based on the current state being sub-process 1.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 1.1, which in this example causes processor 110 to perform the following operations.

[0096] In sub-process 1.1, coordination system 108 requests input device 112 to instruct a physician to provide physician details (i.e., identifying the physician who will perform the patient biomaterial collection). In this example, input device 112 hosts a web application that communicates with coordination system 108. In this example, instructions are displayed on a user interface 116 associated with input device 112, but instructions may be provided to the physician via other or alternative means (e.g., audio instructions). User interface 116 receives input of the physician's details, and input device 112 transmits the input physician details to coordination system 108. Coordination system 108 determines that the received physician details should be stored on the blockchain. Therefore, coordination system 108 stores the physician details on the blockchain by submitting a write request to the gatekeeper component to transact with the physician details. The write request includes a smart contract identifier. In response to receiving the write request, the gatekeeper component executes a process to create a new entity transaction for the data and submits the entity transaction to the blockchain, associating it with the relevant smart contract 124 for the current CAR-T treatment procedure. Coordination system 108 receives confirmation from the gatekeeper that the data has been stored on the blockchain and determines that subprocess 1.1 has been completed. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 1.2, coordination system 108 writes to the distributed ledger, updating the current state of smart contract 124 to subprocess 1.2 in the same manner as subprocess 1.1.

[0097] Based on the current state being sub-process 1.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 1.2, which in this example causes processor 110 to perform the following operations.

[0098] In subprocess 1.2, coordination system 108 requests input device 112 to request the physician to provide detailed information about the patient from whom biomaterials are to be collected. Input device 112 provides instructions by displaying them on user interface 116. User interface 116 receives the patient details entered by the physician, and input device 112 transmits the entered patient details to coordination system 108. Coordination system 108 determines that the received patient details should be stored on the blockchain. Therefore, coordination system 108 stores the patient details on the blockchain (using the same steps as described in subprocess 1.1 above). After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that subprocess 1.2 and Milestone 1 are complete. Since smart contract 124 specifies that the next milestone is Milestone 2 and the next subprocess to be implemented is Subprocess 2.1, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to Milestone 2, Subprocess 2.1, in the same manner as described in subprocess 1.1 above. Milestone 2

[0099] like Figure 11 As shown, the second milestone in this example is "Patient Collection." At this milestone, the doctor collects a blood sample from the patient.

[0100] Based on the current state being sub-process 2.1, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 2.1, which in this example causes processor 110 to perform the following operations.

[0101] In subprocess 2.1, coordination system 108 instructs input device 112 to notify the physician that they need to enter information identifying the biomaterial type and the associated procedure or application for the biomaterial (e.g., via instructions displayed on user interface 116). User interface 116 receives input from the physician identifying the biomaterial as PBMNC and the procedure as CAR-T therapy. Input device 112 transmits this input to coordination system 108. Upon receiving this input (which forms state information for the biomaterial), coordination system 108 processes the state information identifying the biomaterial type and its application. This processing includes coordination system 108 validating the state information to determine whether the identified biomaterial type and application are valid for smart contract 124. If the validation is successful, coordination system 108 determines that the identified biomaterial type and application will be stored on the blockchain. If the validation is unsuccessful, coordination system 108 instructs input device 112 to notify the user of the validation failure and request new input. Coordination system 108 may store a copy of the received state information in data lake 128. After processing, the coordination system 108 stores the state information to the blockchain (using the same steps described above in sub-process 1.1).

[0102] After receiving confirmation from the gatekeeper that the data has been stored on the blockchain, coordination system 108 determines that sub-process 2.1 is complete. Since smart contract 124 specifies that the next sub-process to be implemented is sub-process 2.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 2.2, in the same manner as sub-process 1.1 above.

[0103] Based on the current sub-process being sub-process 2.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 2.2, which in this example causes processor 110 to perform the following operations.

[0104] In subprocess 2.2, coordination system 108 instructs input device 112 to notify the physician that they need to enter status information regarding the volume and mass of the collected blood sample (e.g., via instructions displayed on user interface 116). User interface 116 receives input from the physician, identifying the volume and mass of the collected blood sample. While in this example, the status information is entered by the physician using user interface 116, in other examples, the status information may be received by coordination system 108 from one or more devices 102. Input device 112 transmits this input to coordination system 108, which processes the input volume and mass status information. Processing includes coordination system 108 validating the status information to determine whether the volume and mass of the biomaterial and application are valid for smart contract 124—that is, whether the volume and mass meet predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is successful, coordination system 108 determines that the received volume and mass of the biomaterial will be stored on the blockchain. If the validation is unsuccessful, coordination system 108 instructs input device 112 to notify the physician of the unsuccessful validation and request new input. Coordination system 108 may store a copy of the received state information in data lake 128. After processing, coordination system 108 stores the state information to the blockchain (using the same steps described above in sub-flow 1.1).

[0105] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that sub-process 2.2 is complete. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 2.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 2.3, in the same manner as sub-process 1.1 above.

[0106] Based on the current state being sub-process 2.3, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 2.3, which in this example causes processor 110 to perform the following operations.

[0107] In subprocess 2.3, coordination system 108 determines the packaging requirements for the biological material. Coordination system 108 can make this determination based on status data related to the biological material stored on the blockchain, which can be retrieved by querying the blockchain using the smart contract identifier. Relevant status information can include, for example, the sample quantity and quality stored in subprocess 2.2.

[0108] Coordination system 108 then determines that sub-process 2.3 and Milestone 2 have been completed. Because smart contract 124 specifies that the next milestone and sub-process to be achieved is Milestone 3, sub-process 3.1, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to Milestone 3, sub-process 3.1, in the same manner as described above for sub-process 1.1. Milestone 3

[0109] like Figure 12A and 12B As shown, the third milestone of this example is "leukapheresis." At this milestone, medical scientists use leukapheresis to separate a blood sample to isolate and collect the biological material of interest, namely PBMNCs.

[0110] Based on the current state being sub-process 3.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.1, which in this example causes processor 110 to perform the following operations.

[0111] In sub-process 3.1, coordination system 108 instructs input device 112′ (which may be different from input device 112) to notify the medical scientist that they need to enter the volume of the isolated PBMNC (e.g., via instructions displayed on user interface 116′ associated with input device 112′). User interface 116′ receives input from the medical scientist, identifying the collected volume. Input device 112′ transmits this input to coordination system 108, which processes the volume collection details and then stores them on the blockchain in the same manner as described above.

[0112] Coordination system 108 then receives confirmation from the gatekeeper component that the data has been stored on the blockchain, confirming that sub-process 3.1 has been completed. Since smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.2.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.2.1, in the same manner as sub-process 1.1 above.

[0113] Based on the current state being sub-process 3.2.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.1, which in this example causes processor 110 to perform the following operations.

[0114] In subprocess 3.2.1, coordination system 108 instructs input device 112' to notify the medical scientist that they need to input status information related to the pre-cryopreservation treatment performed on the biological material by the medical scientist using input device 112' (e.g., via instructions displayed on user interface 116'). The pre-cryopreservation treatment may include adding a cryoprotectant and performing one or more baseline measurements (e.g., cell count, cell viability, and / or cell function). User interface 116' receives the input from the medical scientist, identifies the pre-cryopreservation treatment, and input device 112' transmits the input to coordination system 108, which processes the pre-cryopreservation treatment information and then stores it on the blockchain in the same manner as described above.

[0115] Coordination system 108 then receives confirmation from the gatekeeper component that the data has been stored on the blockchain and determines that sub-process 3.2.1 has been completed. Since smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.2.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.2.2, in the same manner as sub-process 1.1 above.

[0116] Based on the current state being sub-process 3.2.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.2, which in this example causes processor 110 to perform the following operations.

[0117] In subprocess 3.2.2, coordination system 108 selects an appropriate packaging facility 126 for the biomaterial. According to executable instructions, the selection is based at least on the packaging requirements determined in subprocess 2.3. Coordination system 108 generates a packaging facility identifier for selected packaging facility 126. Coordination system 108 stores the selection of packaging facility 126 (including the packaging facility identifier) on the blockchain in the same manner as described above, and subsequently receives confirmation from the gatekeeper component that the data has been stored on the blockchain.

[0118] The coordination system 108 notifies the selected packaging device 126 that it has been selected for the current CAR-T treatment procedure. Notifying the packaging device 126 may include the coordination system 108 sending a message to the packaging device 126. The message may include a smart contract identifier or other information notifying the packaging device that it has been selected, and optionally the treatment procedure for which it has been selected.

[0119] The coordination system 108 instructs the input device 112' to notify the medical scientists that they need to transfer the biological material (isolated PBMNCs that have undergone pre-cryopreservation treatment) to the selected packaging device 126 (eg, via instructions displayed on the user interface 116').

[0120] Coordination system 108 then confirms that sub-process 3.2.2 has been completed. Since smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.2.3, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to sub-process 3.2.3, in the same manner as sub-process 1.1 above.

[0121] Based on the current state of sub-process 3.2.3, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.3. In this example, processor 110 requests packaging device 126 to initiate monitoring using sensor 308 and provide monitoring information to coordination system 108. The monitoring information is generated based on monitoring data captured by sensor 308 of packaging device 126. In this example, the monitoring information includes temperature monitoring information and location tracking information. The temperature monitoring information indicates the temperature of the biomaterial within packaging device 126 and is generated based on monitoring data from the temperature sensor. The location tracking information indicates the location of packaging device 126 (and the biomaterial) and is generated based on monitoring data from a location sensor (e.g., a GPS sensor). Coordination system 108 also receives identification information, including a smart contract identifier, from the monitoring information. The identification information may also include a packaging device identifier for packaging device 126.

[0122] The initiated monitoring continues throughout Milestone 3, i.e., while sub-processes 3.2.4–3.2.7 are executed. When the coordination system 108 receives the monitoring information and identification information, it uses the smart contract identifier to query the blockchain and retrieve the smart contract 124 for the current CAR-T treatment procedure, including the current state of the smart contract 124. Based on the retrieved smart contract 124 and the current state (which can be any of sub-processes 3.2.3–3.2.7), the coordination system 108 queries the data storage location 114 to retrieve the executable instructions for the sub-process. These instructions, when executed, cause the processor 110 to process the received monitoring information. Processing includes the coordination system 108 validating the monitoring information to determine whether the received temperature monitoring information and location tracking information meet predefined transition conditions. For example, the temperature monitoring information may be required to be within a certain range required to maintain the biological material within the packaging device 126. If the validation is unsuccessful, the coordination system 108 may send an alert to the medical scientist via the input device 112′ and the user interface 116′. If the validation is successful, the coordination system 108 determines the portion of the monitoring information to be stored on the blockchain. For example, if the temperature monitoring information includes temperature measurements taken every second, the coordination system 108 may determine that the measurements taken every minute are to be stored on the blockchain. After processing, the coordination system 108 stores a portion of the monitoring information on the blockchain (using the same steps described above in sub-process 1.1).

[0123] As described above, coordination system 108 may store a copy of all received monitoring information in data lake 128 .

[0124] As described above, the packaging device 126 may store a copy of the monitoring information locally to the packaging device's data store 306. The coordination system 108 may receive the local copy of the monitoring information at a later stage, for example, for data integrity or data recovery purposes.

[0125] After initiating monitoring, coordination system 108 determines that sub-process 3.2.3 is complete, even though the initiated monitoring process will continue throughout the milestone. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.2.4, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.2.4, in the same manner as sub-process 1.1 above.

[0126] Based on the current state being sub-process 3.2.4, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.4, which in this example causes processor 110 to perform the following operations.

[0127] In subprocess 3.2.4, coordination system 108 determines that the biological material should be maintained at a holding temperature in packaging equipment 126 until cryopreservation. The holding temperature may include an acceptable temperature range. Therefore, if any temperature monitoring information received as a result of the monitoring initiated in subprocess 3.2.3 exceeds the holding temperature range, coordination system 108 generates an alert. Coordination system 108 then determines that subprocess 3.2.4 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 3.2.5, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 3.2.5, in the same manner as described above.

[0128] Based on the current state being sub-process 3.2.5, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.5, which in this example causes processor 110 to perform the following operations.

[0129] In subprocess 3.2.5, at least one of the packaging device 126 and the first cryopreservation device (belonging to the plurality of devices 102) notifies the coordination system 108 that the first cryopreservation device is aware of the packaging device 126. The first cryopreservation device may learn about the packaging device 126 by detecting its proximity, for example using a LAN, WAN, or PAN (e.g., via Wi-Fi, cellular network, RFID, Bluetooth, etc.). In response to being notified, the coordination system 108 may notify the first cryopreservation device that it will be used for the current CAR-T treatment process, linking it to the smart contract 124. This may include transmitting a smart contract identifier to the first cryopreservation device. Additionally or alternatively, it may include transmitting status information related to the biological material (to be cryopreserved by the device) (e.g., volume and quality information received at subprocess 2.2) to the first cryopreservation device.

[0130] When the first cryopreservation device knows the packaging device 126, it may also be informed of one or more of the following information (obtained directly from the packaging device 126 via a LAN, WAN, or PAN, or obtained via the coordination system 108): the type of packaging device 126 selected in subprocess 3.2.2 (e.g., including size, shape, and / or configuration), the type of biological material, and the pre-cryopreservation treatment performed at 3.2.1 (e.g., the amount of cryoprotectant added).

[0131] In some embodiments, coordination system 108 learning that the first cryogenic storage device is aware of packaging device 126 may result in coordination system 108 allowing packaging device 126 to be inserted into the first cryogenic storage device, eg, by communicating with the first cryogenic storage device to unlock the device.

[0132] Coordination system 108 then recognizes that subprocess 3.2.5 has completed. Since smart contract 124 indicates that the next subprocess to be implemented is subprocess 3.2.6, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 3.2.6, in the same manner as subprocess 1.1 above.

[0133] Based on the current state being sub-process 3.2.6, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.6, which in this example cause processor 110 to perform the following operations.

[0134] In subprocess 3.2.6, the coordination system 108 receives status information in the form of a selected scaffold system and a cryopreservation protocol for cryopreservation of biomaterials for CAR-T therapy purposes. The status information may be received via a secure API or any other known communication mechanism. The scaffold system is configured to support one or more packaging devices within a first cryopreservation device to facilitate cryopreservation of biomaterials within the packaging devices. Scaffold systems having different configurations may be used with the first cryopreservation device to achieve different heat transfer rates, and therefore, certain scaffold systems may be more suitable for use with certain packaging devices and biomaterials. The cryopreservation protocol defines the cryopreservation settings of the first cryopreservation device for optimally cryopreserving the biomaterials in the packaging device 126, including processing time, temperature, and heat exchange fluid rate for the cryopreservation process.

[0135] The first cryopreservation device can select a scaffold system based on one or more of the following: the type of packaging device 126, the type of biomaterial (i.e., CAR-T cells in this example), the volume of the biomaterial (e.g., the number of cells), and the quality of the biomaterial. The cryopreservation device can select a cryopreservation protocol based on one or more of the following: the type of packaging device 126, the type of biomaterial (i.e., CAR-T cells in this example), the volume of the biomaterial (e.g., the number of cells), and the quality of the biomaterial.

[0136] Coordination system 108 processes the received state information by validating it and determining that it should be stored on the blockchain, and then writes it to the blockchain to store the state information (using the same steps as described in sub-process 1.1 above). In embodiments where the first cryogenic storage device is configured to host at least one node 122 of the distributed ledger, coordination system 108 may submit the write request to a gatekeeper component, where the gatekeeper component is located on the first cryogenic storage device.

[0137] Coordination system 108 then confirms that subprocess 3.2.6 has been completed. Since smart contract 124 specifies that the next subprocess to be completed is subprocess 3.2.7, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 3.2.6, in the same manner as subprocess 1.1 above.

[0138] The coordination system 108 may request the input device 112' to instruct the medical scientist to load the selected stent system into the first cryopreservation device, such as by displaying instructions on the user interface 116'.

[0139] Alternatively, in sub-process 3.2.6, the coordination system 108 receives a request from the first cryopreservation device via a secure API to obtain a selection of a scaffold system and a cryopreservation protocol for cryopreserving biological materials for use in CAR-T therapy.

[0140] The coordination system 108 processes the received request by confirming that the first cryogenic storage device is one of the plurality of devices 102 and is therefore authorized to interact with the coordination system 108 and confirming the current state of the smart contract by querying the blockchain using the smart contract identifier.

[0141] Once coordination system 108 processes the request, it invokes a query process on the blockchain through the gatekeeper component. The gatekeeper component executes the query on the blockchain to obtain the required information, namely, the current process's scaffolding system and the selected cryopreservation protocol. The blockchain query data results and the required information are returned from the blockchain to coordination system 108 via the gatekeeper component. Coordination system 108 processes the blockchain query data results and then transmits them to the first cryopreservation device via a secure API.

[0142] In an embodiment where the first cryogenic storage device is configured to host at least one node 122 of a distributed ledger, the coordination system 108 may instruct the first cryogenic storage device to directly invoke a query process on the blockchain via a gatekeeper component on the first cryogenic storage device.

[0143] The coordination system 108 may request the input device 112' to instruct the medical scientist to load the selected stent system into the first cryopreservation device, such as by displaying instructions on the user interface 116'.

[0144] Coordination system 108 receives confirmation from the first cryopreservation unit that it has received the selected scaffold system and cryopreservation protocol. Coordination system 108 then determines that subprocess 3.2.6 is complete. Because smart contract 124 specifies that the next subprocess to be completed is subprocess 3.2.7, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 3.2.6, in the same manner as described above for subprocess 1.1.

[0145] Based on the current state being sub-process 3.2.7, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2.7, which in this example causes processor 110 to perform the following operations.

[0146] At subprocess 3.2.7, the coordination system 108 notifies other relevant devices in the plurality of devices 102 that they will be needed in future milestones related to the CAR-T treatment process, thereby linking them to the smart contract 124. In this example, the first thawing device at milestone 6, the second cryopreservation device at milestone 9, and the second thawing device at milestone 11 are notified. Notifying the relevant devices may include transmitting a smart contract identifier of the smart contract 124 to each device. Notifying the relevant devices may include transmitting status information related to the biological material, such as the type of packaging device 126 selected in subprocess 3.2.2 (e.g., including size, shape, and / or configuration), the type of biological material, and the pre-cryopreservation treatment performed at 3.2.1 (e.g., the amount of cryoprotectant added).

[0147] The coordination system 108 then determines that sub-process 3.2.7 is complete.

[0148] The coordination system 108 determines whether the volume of the isolated PBMNC meets a predetermined threshold (or Figure 9 The threshold is the minimum volume required for the CAR-T treatment process to proceed. For example, to treat diffuse large B-cell lymphoma in an 80 kg patient, the threshold can be approximately 10×10 8 If the threshold is not reached, the coordination system 108 writes to the blockchain to update the current state of the smart contract to include sub-process 1.2, prompting additional iterations of Milestones 2 and 3 and obtaining additional biological material to allow the process to continue. In the additional iteration of Milestone 3, the threshold will be adjusted to account for any volume collected in previous iterations of Milestones 2 and 3.

[0149] If multiple samples were collected and separated (because the threshold was not met as described above), then at the end of Milestone 3, coordination system 108 requests input device 112' to instruct the medical scientist to merge all separated samples into a single packaging device 126 (e.g., by displaying instructions on user interface 116').

[0150] Once the coordination system 108 determines that sub-process 3.2.7 and milestone 3 are completed, because the smart contract 124 stipulates that the next milestone and sub-process to be achieved are milestone 4 and sub-process 4.1, the coordination system 108 writes to the blockchain to update the current state of the smart contract 124 to milestone 4 sub-process 4.1, in the same manner as sub-process 1.1 above (if the coordination system 108 determines at milestone 3 that the volume of the separated PBMNC does not meet the predetermined threshold, the current state also includes 1.2). Milestone 4

[0151] like Figure 13 As shown, the fourth milestone of this example is "controlled preservation." At this milestone, the medical scientist places the packaging device 126 in a first cryopreservation device that freezes the biological material in the packaging device 126 at a controlled rate.

[0152] Subprocess 4.1 is performed in the same manner as subprocess 3.2.3 above, but a request to initiate monitoring is sent to the first cryopreservation device. The first cryopreservation device generates monitoring information based on the monitoring data captured by its sensor 208. In subprocess 4.1, the monitoring information may include temperature monitoring information (i.e., information about the temperature during cryopreservation) and operation monitoring information. The temperature monitoring information indicates the temperature of the biological material within the packaging device 126 and is generated based on the monitoring data of the temperature sensor. The operation monitoring information indicates one or more operations performed by the first cryopreservation device, such as the speed of the heat exchange fluid. Via the monitoring information, the coordination system 108 also receives identification information including a smart contract identifier. The identification information may also include a device identifier of the first cryopreservation device.

[0153] The initiated monitoring continues throughout Milestone 4, i.e., while subprocess 4.2 is being executed. When the coordination system 108 receives the monitoring information and identification information, it uses the smart contract identifier to query the blockchain and retrieve the smart contract 124 for the current CAR-T treatment process, including the current state of the smart contract 124. Based on the retrieved smart contract 124 and the current state (which may be subprocess 4.2 at this point), the coordination system 108 queries the data storage location 114 to retrieve the executable instructions for the subprocess. When executing these instructions, the processor 110 processes the received monitoring information. Processing includes the coordination system 108 verifying the state information to determine whether the received temperature monitoring information and operational monitoring information meet predefined transition conditions. For example, operational monitoring information may be required to be within a specific range to confirm that no operational failures or other unforeseen events have occurred within the first cryopreservation device. If the verification is unsuccessful, the coordination system 108 may send an alert to the medical scientist via the input device 112' and the user interface 116'. If the verification is successful, the coordination system 108 determines the portion of the monitoring information to be stored on the blockchain. For example, if the operational monitoring information includes monitoring information for multiple operations performed by the first cryogenic storage device, the coordination system 108 may determine that only the monitoring information for certain operations should be stored on the blockchain. After processing, the coordination system 108 stores a portion of the monitoring information on the blockchain (using the same steps described above in sub-process 1.1).

[0154] Processing the operation monitoring information may also include generating cost monitoring information based on the operation monitoring information, the cost monitoring information indicating the cost associated with operating the first cryopreservation device to perform cryopreservation of biological materials; determining a portion of the cost monitoring information to be stored on the blockchain; and storing the portion of the cost monitoring information to the blockchain (using the same steps described above in sub-process 1.1).

[0155] After initiating monitoring, coordination system 108 determines that subprocess 4.1 is complete, even though the initiated monitoring will continue throughout the milestone. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 4.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 4.2, in the same manner as described above for subprocess 1.1.

[0156] Based on the current state being sub-process 4.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 4.2, which in this example causes processor 110 to perform the following operations.

[0157] In sub-process 4 . 2 , the coordination system 108 controls the first cryopreservation device to adjust its refrigeration system to achieve the required operating conditions according to the cryopreservation plan received at milestone 3 .

[0158] Coordination system 108 determines that subprocess 4.2 has been completed by determining, for example, based on operational monitoring information, that the first cryopreservation unit has met the required operational conditions of the cryopreservation protocol (selected in subprocess 3.2.6). Because smart contract 124 specifies that the next milestone and subprocess to be achieved are Milestone 5 and Subprocess 5.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 5 and Subprocess 5.1, in the same manner as described above for Subprocess 1.1. Milestone 5

[0159] like Figure 14 As shown, the fifth milestone of this example is "Specialized Logistics." At this milestone, the biological material within packaging facility 126 is maintained in a controlled and monitored environment while being transported between the locations at milestones 2-4 and milestone 6.

[0160] Sub-process 5.1 is executed in the same manner as sub-process 3.2.3 described above. The initiated monitoring continues throughout Milestone 5, i.e., while sub-process 5.2 is executed. After the monitoring is initiated, coordination system 108 determines that sub-process 5.1 is complete, even though the initiated monitoring will continue throughout the milestone.

[0161] Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 5.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 5.2, in the same manner as the execution of sub-process 1.1 described above.

[0162] Based on the current state being sub-process 5.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 5.2, which in this example causes processor 110 to perform the following operations.

[0163] In subprocess 5.2, coordination system 108 determines a target destination for the biological material within packaging facility 126. In this example, the target destination corresponds to the location of the first thawing device, which is predefined and stored on the blockchain. Based on the location tracking information received and stored due to the monitoring initiated at subprocess 5.2, coordination system 108 can also determine a route (e.g., an optimal route) to the target destination.

[0164] Once the coordination system 108 processes the request, it transmits the target destination to the secure API, which in turn transmits the target destination to the packaging device 126.

[0165] Coordination system 108 receives confirmation from packaging equipment 126 that the target destination has been received. Coordination system 108 then determines that sub-process 5.2 and Milestone 5 are complete. Because smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 6 and Sub-process 6.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 6 and Sub-process 6.1, in the same manner as described above for Sub-process 1.1. Milestone 6

[0166] like Figure 15 As shown, the sixth milestone of this example is "controlled biological thawing." At this milestone, the first thawing device thaws the cryopreserved biological material in preparation for the transformation and amplification at milestone 7.

[0167] Subprocess 6.1 is executed in the same manner as subprocess 4.1 above, except that a request to initiate monitoring is sent to the first thawing device. The first thawing device generates monitoring information based on the monitoring data captured by its sensor 208. In subprocess 6.1, the monitoring information may include temperature monitoring information (i.e., monitoring the temperature during cryopreservation) and operational monitoring information. The temperature monitoring information indicates the temperature of the biological material within the packaging device 126 and is generated based on the monitoring data from the temperature sensor. The operational monitoring information indicates one or more operations performed by the first thawing device, such as the thawing temperature applied by the device.

[0168] The initiated monitoring continues throughout Milestone 6, i.e., while sub-processes 6.2 and 6.3 are executed. After initiating monitoring, coordination system 108 determines that sub-process 6.1 has completed, even though the initiated monitoring will continue throughout the milestone. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 6.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 6.2, in the same manner as described above for sub-process 1.1.

[0169] Based on the current state being child process 6.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of child process 6.2, which in this example causes processor 110 to perform the following operations.

[0170] In sub-process 6.2, the coordination system 108 receives status information in the form of a selected thawing protocol for thawing the biological material in the packaging device. The thawing protocol defines the thawing settings of the first thawing device, including the heating rate and temperature of the thawing process.

[0171] The status information is received from the first thawing device via a secure API. The first cryopreservation device can select a thawing protocol based on one or more of the following: the type of packaging device 126, the type of biological material (i.e., CAR-T cells in this example), the volume of the biological material (e.g., the number of cells), and the temperature at which the biological material has been stored within the packaging device 126 since cryopreservation.

[0172] Coordination system 108 processes the received state information by validating it and determining that it should be stored on the blockchain, then writes to the blockchain to store the state information (using the same steps described above in subprocess 1.1). Coordination system 108 then determines that subprocess 6.2 has completed. Since smart contract 124 specifies that the next subprocess to be completed is subprocess 6.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 6.3, in the same manner as described above for subprocess 1.1.

[0173] Alternatively, in sub-process 6.2, the coordination system 108 receives a request from the first thawing device through a secure API to obtain a selection of a thawing plan for thawing the biological material in the packaging device 126, including a heating rate and a temperature of the thawing process.

[0174] The coordination system 108 processes the received request by confirming that the first unfrozen device is one of the plurality of devices 102 and is therefore authorized to interact with the coordination system, and confirming the current state of the smart contract by querying the blockchain using the smart contract identifier.

[0175] Once coordination system 108 processes the request, it invokes a query process on the blockchain via the gatekeeper component. The gatekeeper component executes a query on the blockchain to obtain the required information, namely, the selected thawing solution for the current process. The blockchain query data results containing the required information are returned from the blockchain to coordination system 108 via the gatekeeper component. Coordination system 108 processes the blockchain query data results and then transmits them to the secure API. The secure API transmits the blockchain query results to the first thawing device. The first thawing device uses the thawing solution received in subprocess 6.3 to thaw the biological material in packaging device 126.

[0176] Coordination system 108 receives confirmation from the first unfreezing device that the selected unfreezing solution has been received. Coordination system 108 then determines that subprocess 6.2 has been completed. Since smart contract 124 specifies that the next subprocess to be completed is subprocess 6.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 6.3, in the same manner as subprocess 1.1 above.

[0177] Based on the current state being sub-process 6.3, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 6.3, which in this example causes processor 110 to perform the following operations.

[0178] In subprocess 6.3, coordination system 108 controls the first thawing device to adjust its refrigeration system to achieve the required operating conditions according to the thawing plan received in subprocess 6.2. Coordination system 108 determines that subprocess 6.3 has been completed by determining (for example, based on operational monitoring information) that the first thawing device has met the required operating conditions of the thawing plan (received in subprocess 6.2). Because smart contract 124 specifies that the next milestone and subprocess to be achieved are Milestone 7 and Subprocess 7.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 7 and Subprocess 7.1, in the same manner as described above for subprocess 1.1. Milestone 7

[0179] like Figure 16 As shown, the seventh milestone in this case is “Differentiation and Transformation.” At this milestone, the thawed biomaterial undergoes differentiation and transformation to produce CAR-T cells. This typically involves medical scientists performing the following steps: i. Remove the biological material from the packaging device 126; ii. Select a vector and use it to remove the gene of interest from cells containing DNA (the removed DNA can be frozen and stored, then thawed when used); iii. Performing a DNA plasmid process, which may include isolation of the plasmid and recombination of the plasmid with the gene of interest to produce a recombinant DNA plasmid; iv. transforming the recombinant DNA plasmid with PBMNC, for example by transfection, to produce recombinant T cells (ie, CAR-T cells); and v. Differentiation of CAR-T cells, for example, by cell sorting using flow cytometry.

[0180] Based on the current state being sub-process 7.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.1, which in this example causes processor 110 to perform the following operations.

[0181] In subprocess 7.1, the coordination system 108 instructs the input device 112" (which may be different from the input devices 112 and 112') to notify the medical scientists performing the differentiation and transformation steps that they need to input status information related to the steps taken when generating the CAR-T cells. For example, the required information may include: the selected carrier, the identity of any medium or cryoprotectant added or removed at each step, the time required to complete each step, the total time required to generate the CAR-T cells, the cell count of the biological material removed from the packaging device 126, and the viability count of the biological material removed from the packaging device 126. The instructions can be provided by displaying them on a user interface 116" associated with the input device 112".

[0182] The coordination system 108 receives state information input by the medical scientist via the user interface 116 ″ from the input device 112 ″. Utilizing the state information, the coordination system 108 also receives identification information, including a smart contract identifier. Using the identification information, the coordination system 108 queries the blockchain to retrieve the current state of the smart contract 124 and subprocess 7.1. Based on the current state of subprocess 7.1, the coordination system 108 queries the data storage location 114 to retrieve executable instructions, which the coordination system 108 executes to process the state information. Processing includes validating the state information to determine whether the input information meets predefined transition conditions. For example, the transition conditions may be defined in the executable instructions based on one or more regulatory requirements for a process for generating CAR-T cells used in CAR-T therapy. If validation is unsuccessful, the coordination system 108 marks the state information invalid to identify that it failed validation and instructs the input device 112 ″ to notify the medical scientist of the unsuccessful validation. The medical scientist can then determine whether the differentiation and transformation steps need to be repeated, or whether the generated CAR-T cells cannot be used in CAR-T therapy (meaning that the current process must be terminated).

[0183] The process also includes coordination system 108 determining a portion of the state information to be stored on the blockchain (where the portion may include all of the state information). Coordination system 108 may store a copy of the received state information in data lake 128. After the process is complete, coordination system 108 stores the determined portion of the state information on the blockchain (using the same steps described above in sub-process 1.1).

[0184] Coordination system 108 then determines that subprocess 7.1 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 7.2, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to subprocess 7.2, in the same manner as described above for subprocess 1.1.

[0185] Based on the current state being sub-process 7.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.2, which in this example causes processor 110 to perform the following operations.

[0186] In sub-process 7.2, the coordination system 108 instructs the input device 112″ to notify the medical scientists performing the differentiation and transformation steps that they need to input status information related to the final product biological material (i.e., the generated CAR-T cells). For example, the required information may include (but is not limited to): confirmation that the CAR-T cells have the correct protein markers, the cell count of the CAR-T cells, and the viability count of the CAR-T cells. As for sub-process 7.1, the instructions can be provided by displaying the instructions on the user interface 116″ associated with the input device 112″.

[0187] The coordination system 108 receives state information input by the medical scientist via the user interface 116 ″ from the input device 112 ″. Utilizing this state information, the coordination system 108 also receives identification information including a smart contract identifier. Using the identification information, the coordination system 108 queries the blockchain to retrieve the current state of the smart contract 124 and sub-process 7 . 1 . Based on the current state of sub-process 7 . 1 , the coordination system 108 queries the data storage location 114 to retrieve executable instructions, which the coordination system 108 executes to process the state information. The processing includes validating the state information to determine whether the input information satisfies predefined transition conditions. For example, the transition conditions may be defined in the executable instructions based on one or more regulatory requirements for CAR-T cells used in CAR-T therapy. If the validation is unsuccessful, coordination system 108 marks the invalid state information to indicate that it has failed validation and instructs input device 112″ to notify the user that the validation was unsuccessful. Processing also includes coordination system 108 determining a portion of the state information to be stored on the blockchain (wherein the portion may include all of the state information). Coordination system 108 may store a copy of the received state information in data lake 128. After processing, coordination system 108 stores the determined portion of the state information on the blockchain (using the same steps described above in sub-process 1.1).

[0188] In some embodiments, in subprocess 7.2, executing the executable instructions of subprocess 7.2 also causes the coordination system 108 to determine packaging requirements and select an appropriate packaging device 126' for the biological material (now in the form of differentiated CAR-T cells). This can be performed similarly to the steps described in subprocesses 2.3 and 3.2.2 (regarding determining packaging requirements and selecting packaging device 126). The coordination system 108 instructs the input device 112" to notify the medical scientist that they need to transfer the biological material (differentiated CAR-T cells) to the selected packaging device 126' (e.g., via instructions displayed on the user interface 116"). However, as further described below in subprocess 8.1, in some embodiments, the selection of the packaging device 126' may not occur until after the biological material has undergone expansion.

[0189] Coordination system 108 then determines that Milestone 7 and Sub-Process 7.2 are complete. Since smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 8 and Sub-Process 8.1, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to Milestone 8 Sub-Process 8.1 in the same manner as Sub-Process 1.1 above. Milestone 8

[0190] like Figure 17 As shown, the eighth milestone in this example is “expansion.” At this milestone, medical scientists multiply or “expand” the CAR-T cells in the laboratory to a number sufficient for use in CAR-T therapy.

[0191] Based on the current state being sub-process 8.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.1, which in this example cause processor 110 to perform the following operations.

[0192] In subprocess 8.1, the coordination system 108 requests the input device 112″ to instruct the medical scientist to expand the CAR-T cells and input status information related to the expanded cells. For example, the required information may include the final volume of the expanded cells, the final cell count of the expanded cells, the quality and / or viability measurement of the expanded cells, and the identity and volume of any culture medium or cryoprotectant added to the expanded cells. The instructions can be provided to the medical scientist by displaying the instructions on the user interface 116″.

[0193] The coordination system 108 receives state information from the input device 112″ (received from the medical scientist at the user interface 116″). With this state information, the coordination system 108 also receives identification information, including a smart contract identifier. The coordination system 108 uses the identification information to query the blockchain to retrieve the current state of the smart contract 124 and the milestone 8 sub-process 8.1. Based on the current state of the sub-process 8.1, the coordination system 108 queries the data storage location 114 to retrieve executable instructions, which the coordination system 108 executes to process the state information. The processing includes the coordination system 108 validating the state information to determine whether the state information is valid for the smart contract 124 - for example, whether the expansion volume meets predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is unsuccessful, the coordination system 108 marks the state information invalid to indicate that it has failed validation and instructs the input device 112 to notify the user that the validation was unsuccessful. The process also includes the coordination system 108 determining a portion of the state information to be stored on the blockchain (where the portion may include all of the state information). The coordination system 108 may store a copy of the received augmentation volume in the data lake 128. Once processed, the coordination system 108 stores the state information on the blockchain (using the same steps described above in sub-process 1.1).

[0194] In some embodiments, in subprocess 8.1, executing the executable instructions of subprocess 8.1 also causes the coordination system 108 to determine packaging requirements and select an appropriate packaging device 126' for the biological material (now in the form of expanded CAR-T cells). This can be performed similarly to the steps described in subprocesses 2.3 and 3.2.2 (related to determining packaging requirements and selecting packaging device 126). The coordination system 108 instructs the input device 112" to notify the medical scientist that they need to transfer the biological material (expanded CAR-T cells) to the selected packaging device 126' (e.g., via instructions displayed on the user interface 116"). However, as described above in subprocess 7.2, in some embodiments, the selection of the packaging device 126' occurs before the biological material is expanded. Whether this occurs before or after the biological material is expanded may depend on the specific CAR-T treatment process being performed.

[0195] Coordination system 108 then determines that subprocess 8.1 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 8.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 8.2, in the same manner as subprocess 1.1 above.

[0196] Based on the current sub-process being sub-process 8.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.2, which in this example causes processor 110 to perform the following operations.

[0197] In subprocess 8.2, the coordination system 108 requests the input device 112" to instruct the medical scientist to determine and input whether subsequent expansion cycles are required based on the volume of the expanded CAR-T cells. Instructions can be provided to the medical scientist by displaying the instructions on the user interface 116".

[0198] The coordination system 108 receives status information from the input device 112″, which is in the form of user input from the medical scientist for identifying whether further expansion cycles are required (received at the user interface 116″). Using the status information, the coordination system 108 also receives identification information including a smart contract identifier. Using the identification information, the coordination system 108 queries the blockchain to retrieve the current state of the smart contract 124 and sub-process 8.2. Based on the current state being sub-process 8.2, the coordination system 108 queries the data storage location 114 to retrieve executable instructions, which the coordination system 108 executes to process the status information. The processing includes the coordination system 108 validating the status information and determining that it is to be stored to the blockchain. The coordination system 108 stores the status information to the blockchain (using the same steps as in sub-process 1.1 above). After receiving confirmation from the gatekeeper component that the data has been stored to the blockchain, the coordination system 108 determines that sub-process 8.2 is complete.

[0199] After completing subprocess 8.2, the current state of smart contract 124 is updated based on the "transition condition." If the input identifier requires at least one further amplification cycle, the "transition condition" fails, and smart contract 124 indicates that the next subprocess to be implemented is subprocess 8.1, and the process repeats as described above. If the input identifier does not require further amplification cycles, the "transition condition" passes, and smart contract 124 indicates that the next subprocess to be implemented is subprocess 8.3. Depending on the outcome of the transition condition, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to either subprocess 8.1 or 8.3, in the same manner as described above for subprocess 1.1.

[0200] If the current sub-process is sub-process 8.3, then coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.3, which in this example causes processor 110 to perform the following operations.

[0201] In subprocess 8.3, coordination system 108 determines that the (amplified) biological material should be maintained at a holding temperature in packaging device 126 until it is cryopreserved (8.3.1), and requests packaging device 126 to initiate monitoring of sensor 308 and provide monitoring information to coordination system 108. The holding temperature may include a range of acceptable temperatures. The temperature monitoring information is generated in the same manner as described in subprocess 3.2.3. The initiated monitoring will continue for the remainder of Milestone 8, i.e., during the execution of subprocesses 8.4 and 8.5, in the same manner as described in subprocess 3.2.3, with coordination system 108 storing the relevant determined portion of the monitoring information on the blockchain (using the same steps as described in subprocess 1.1 above).

[0202] Therefore, if any received temperature monitoring information exceeds the holding temperature range, coordination system 108 can generate an alarm. If the amplification process in subprocess 8.1 is not performed while the biological material is in packaging device 126, coordination system 108 can request input device 112" to instruct the medical scientist to return the amplified biological material to packaging device 126 by displaying instructions on user interface 116".

[0203] The coordination system 108 then determines that subprocess 8.3 is complete. Since the smart contract 124 specifies that the next subprocess to be implemented is subprocess 8.4, the coordination system 108 writes to the blockchain to update the current state of the smart contract 124 to include subprocess 8.4, in the same manner as described above.

[0204] Based on the current state being sub-process 8.4, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.4, which in this example causes processor 110 to perform the following operations.

[0205] In subprocess 8.4, packaging device 126 and at least one of the second cryogenic storage facility (of the plurality of facilities 102) notify coordination system 108 that the second cryogenic storage facility is aware of packaging device 126. The second cryogenic storage facility may be aware of packaging device 126 in the same manner as described in subprocess 3.2.5.

[0206] Coordination system 108 then determines that subprocess 8.4 is complete. Since smart contract 124 indicates that the next subprocess to be implemented is subprocess 8.5, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 8.5, in the same manner as described above in subprocess 1.1.

[0207] Based on the current state of subprocess 8.5, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of subprocess 8.5 in the same manner as described in subprocess 3.2.6, except that coordination system 108 receives status information in the form of the selected scaffold system and cryopreservation protocol for cryopreserving the expanded biological material in the second cryopreservation device for CAR-T therapy. Unlike subprocess 3.2.6, coordination system 108 determines that Milestone 8 and Subprocess 8.5 are completed, determines that the next milestone and subprocess to be achieved are Milestone 9 and Subprocess 9.1, and writes to the blockchain to update the current state of smart contract 124 accordingly. Milestone 9

[0208] like Figure 18 As shown, the ninth milestone in this case is "controlled cryopreservation." At this milestone, medical scientists place the packaging device into a second cryopreservation device, which freezes the expanded CAR-T cells in the packaging device at a controlled rate.

[0209] Sub-process 9.1 corresponds to sub-process 4.1 described above.

[0210] Sub-process 9 . 2 corresponds to sub-process 4 . 2 described above, but for the second cryopreservation device and the cryopreservation protocol received at milestone 8 .

[0211] Coordination system 108 then determines that Milestone 9 and Sub-Process 9.2 are complete. Since smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 10 and Sub-Process 10.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 10 and Sub-Process 10.1, in the same manner as Sub-Process 1.1 described above. Milestone 10

[0212] like Figure 19 As shown, the tenth milestone of this example is "Specialized Logistics." At this milestone, the biological material within packaging facility 126 is maintained in a controlled and monitored environment while being transported between the locations of milestones 6-9 and 11-12.

[0213] Sub-process 10.1 corresponds to sub-process 5.1 described above.

[0214] Sub-process 10.2 corresponds to sub-process 5.2 described above.

[0215] Coordination system 108 then determines that milestone 10 and sub-process 10.2 are complete. Since smart contract 124 specifies that the next milestone and sub-process to be achieved are milestone 11 and sub-process 11.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to milestone 11 and sub-process 11.1, in the same manner as described above for sub-process 1.1. Milestone 11

[0216] like Figure 20 As shown, the eleventh milestone of this example is "controlled biothawing." At this milestone, the cryopreserved CAR-T cells are thawed by a second thawing device to prepare for transplantation at milestone 12.

[0217] Sub-process 11.1 corresponds to sub-process 6.1 described above.

[0218] Sub-process 11.2 corresponds to sub-process 6.2 described above, but is adapted for the second thawing device.

[0219] Sub-process 11.3 corresponds to sub-process 6.3 described above, but is adapted for the second thawing device.

[0220] Coordination system 108 then confirms that Milestone 11 and Sub-Process 11.3 have been completed. Since smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 12 and Sub-Process 12.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 12 and Sub-Process 12.1, in the same manner as described above for Sub-Process 1.1. Milestone 12

[0221] like Figure 21 As shown, the twelfth milestone in this example is "transplantation." At this milestone, a medical professional (e.g., a doctor) transplants the thawed CAR-T cells into the patient's blood.

[0222] Based on the current state being sub-process 12.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 12.1, which in this example causes processor 110 to perform the following operations.

[0223] At milestone 12.1, coordination system 108 instructs input device 112 to notify the physician (who will be performing the transplant) that they need to provide status information in the form of physician details (identifying the physician), patient details (identifying the transplant patient), and biomaterial details (identifying the biomaterial within packaging device 126). Input device 112 may provide instructions to the physician via user interface 116. The physician enters the details using user interface 116, and input device 112 transmits the entered status information to coordination system 108. Coordination system 108 processes the received status information. Processing includes validating the status information to determine whether the physician details, patient details, and biomaterial are valid for smart contract 124. In this example, validation may include querying the blockchain to check whether the physician details, patient details, and biomaterial match the corresponding details stored on the blockchain. If validation is successful, coordination system 108 determines that the entered physician details, patient details, and biomaterial are to be stored on the blockchain. If validation is unsuccessful, coordination system 108 instructs the input device to notify the user of the unsuccessful validation and request new input. Coordination system 108 may store a copy of the received status information in data lake 128. After processing, the coordination system 108 stores the state information to the blockchain (using the same steps described above in sub-process 1.1).

[0224] After receiving confirmation from the gatekeeper that the data has been stored on the blockchain, coordination system 108 determines that subprocess 12.1 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 12.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 12.2, in the same manner as described above for subprocess 1.1.

[0225] Based on the current state being sub-process 12.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 12.2, which in this example cause processor 110 to perform the following operations.

[0226] In sub-process 12.2, coordination system 108 instructs input device 112 to notify the doctor to perform the transplant, for example, by displaying a message on user interface 116. Coordination system 108 then recognizes that milestone 12, sub-process 12.2, and the entire CAR-T process defined by smart contract 124 are complete. Example 2: Assisted reproductive therapy (ART)

[0227] In a second example, the systems and methods described herein are used to control the processing of biological material for ART treatment purposes. In this example, the biological material includes sperm collected from a patient.

[0228] In this example, the distributed ledger is a private blockchain, but in other examples a public blockchain could be used.

[0229] Initially, user interface 116 receives user input requesting the initialization of a new process. This input indicates a desired smart contract template 123 for initializing the smart contract for the current process. Coordination system 108 receives the user input via input device 112 and, based on the user input, is able to determine a template identifier corresponding to the desired smart contract template 123. Coordination system 108 then uses the template identifier to send a request to the blockchain to initialize smart contract 124. This request includes a smart contract identifier, which coordination system 108 generates to associate with the newly initialized smart contract and store with the smart contract on the blockchain.

[0230] In this example, the user input is a selection made by a physician indicating that they wish to initiate an ART procedure. From the received user input, the coordination system 108 is able to identify a relevant template identifier corresponding to the template 123 for the ART procedure. Accordingly, the coordination system 108 uses the ART template identifier to send a request to the blockchain to initialize a new smart contract 124 for ART. This involves generating a new smart contract identifier, which is sent to the blockchain along with the request and associated and stored with the newly initialized smart contract 124.

[0231] When initializing smart contract 124, coordination system 108 updates the current state of smart contract 124 to sub-process 1.1 of Milestone 1. Updating the current state involves submitting a write request for a transaction associated with the current state of sub-process 1.1 to a gatekeeper component associated with the blockchain. The write request includes the smart contract identifier. In response to receiving the write request, the gatekeeper component executes the process of creating a new entity transaction for the data and submits the entity transaction to the blockchain, associated with the relevant smart contract 124 of the current ART process. Coordination system 108 then receives confirmation from the gatekeeper component that the current state has been stored on the blockchain. Milestone 1

[0232] like Figure 22 As shown, the first milestone of this example is "doctor-patient identity verification".

[0233] Sub-processes 1.1 and 1.2 are the same as those in Example 1 (CAR-T therapy) above. However, in this example, the patient can also be described as a donor.

[0234] In sub-process 1.3, coordination system 108 requests input device 112 to instruct the doctor to perform a psychological evaluation on the patient and input the results of the psychological evaluation. The instruction can be provided to the doctor and / or other medical professionals by displaying the instruction on user interface 116 associated with input device 112.

[0235] The psychological assessment may take any appropriate form. For example, the psychological assessment may include an assessment by a physician and an assessment by an ART counselor (e.g., an IVF counselor). The physician's assessment may include determining one or more of the following: the patient's age, the length of time the patient has been trying to conceive, the patient's genetic predisposition, the patient's BMI, the patient's lifestyle, whether the patient smokes, the patient's alcohol consumption, the patient's caffeinated beverage consumption, the patient's physical activity, the patient's stressors, the patient's occupation, and the patient's relationship status. The counselor's assessment may include determining one or more of the following: the patient's informed consent for the ART procedure, the patient's understanding of the risks / benefits / side effects / alternative treatments associated with the ART procedure, the patient's consent to have anonymized patient information and treatment information provided to one or more third-party databases (e.g., the Australian and New Zealand Assisted Reproduction Database (ANZARD)), the patient's understanding of the emotional impact of proceeding with the ART procedure (e.g., related to adverse or undesirable outcomes), and the patient's understanding of the potential personal and social impact of the ART procedure on the individual to be born.

[0236] The results of the psychological assessment are input by the physician and counselor using the user interface 116, and the input device 112 transmits the input to the coordination system 108. After receiving the input (forming the state information of the biomaterial), the coordination system 108 processes the results of the psychological assessment. The processing includes the coordination system 108 verifying the state information to determine whether the results meet predefined transition conditions. For example, the transition conditions can be defined in executable instructions based on one or more regulatory requirements of the ART program. If the verification is successful, the coordination system 108 determines that the results will be stored on the blockchain. If the verification is unsuccessful, the coordination system 108 instructs the input device 112 to notify the user of the unsuccessful verification and request new input. The coordination system 108 can store a copy of the received state information in the data lake 128. After processing, the coordination system 108 stores the state information on the blockchain (using the same steps described in Example 1).

[0237] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that Milestone 1 and Sub-Process 1.3 are complete. Because smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 2 and Sub-Process 2.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 2 and Sub-Process 2.1, in the same manner as described in Example 1 above. Milestone 2

[0238] like Figure 23 As shown, the second milestone in this example is "Patient Collection." At this milestone, the doctor obtains biological material by collecting a semen sample from the patient.

[0239] Sub-process 2.1 is the same as sub-process 2.1 in Example 1, but the user interface 116 receives input from the physician identifying that the biological material is semen and the procedure is ART.

[0240] In sub-process 2.2, coordination system 108 instructs input device 112 to notify the physician that they need to enter status information related to the semen sample collection (e.g., via instructions displayed on user interface 116). In this example, the required information includes the date, time, location, and ambient temperature of the sample collection. While in this example, the physician enters this information using user interface 116, in other examples, the information may be automatically generated by input device 112. Input device 112 transmits this input to coordination system 108, which processes the input status information, including the date, time, location, and ambient temperature of the collection. Processing includes coordination system 108 validating the status information to determine whether the date, time, location, and ambient temperature of the collection are valid for smart contract 124—that is, whether the input meets predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is successful, coordination system 108 determines that the received date, time, location, and ambient temperature should be stored on the blockchain. If the validation is unsuccessful, coordination system 108 instructs input device 112 to notify the physician of the unsuccessful validation and request new input. The coordination system 108 may store a copy of the received state information in the data lake 128. After processing, the coordination system 108 stores the state information to the blockchain (using the same steps described in Example 1 above).

[0241] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that sub-process 2.2 is complete. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 2.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 2.3, in the same manner as described in Example 1 above.

[0242] Based on the current state being sub-process 2.3, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 2.3, which in this example causes processor 110 to perform the following operations.

[0243] In sub-process 2.3, coordination system 108 instructs input device 112 to notify the physician that they need to collect a semen sample from the donor and to enter status information regarding the volume of the collected semen sample (e.g., via instructions displayed on user interface 116). User interface 116 receives input from the physician to identify the volume of the collected semen sample. While in this example, the status information is entered by the physician using user interface 116, in other examples, coordination system 108 may receive the status information from one or more devices 102 (e.g., a device that measures the volume of the collected semen sample). Input device 112 transmits this input to coordination system 108, which processes the input volume status information. This processing includes coordination system 108 validating the status information to determine whether the volume of the biological material is valid for smart contract 124—that is, whether the volume meets predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is successful, coordination system 108 determines to store the received volume on the blockchain. If the validation is unsuccessful, coordination system 108 instructs input device 112 to notify the physician of the unsuccessful validation and request new input. The coordination system 108 may store a copy of the received state information in the data lake 128. After processing, the coordination system 108 stores the state information to the blockchain (using the same steps as in Example 1 above).

[0244] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that sub-process 2.3 is complete. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 2.4, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 2.4, in the same manner as described in Example 1 above.

[0245] Based on the current state being sub-process 2.4, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 2.4, which in this example causes processor 110 to perform the following.

[0246] In subprocess 2.4, coordination system 108 selects an appropriate packaging device 126 for the biomaterial. According to executable instructions, this selection may be based on the volume of biomaterial received in subprocess 2.3. Coordination system 108 generates a packaging device identifier for the selected packaging device 126. Coordination system 108 stores the selection of packaging device 126 (including the packaging device identifier) on the blockchain in the same manner as described above, and subsequently receives confirmation from the gatekeeper component that the data has been stored on the blockchain. Coordination system 108 notifies the selected packaging device 126 that it has been selected for the current ART process. Notifying packaging device 126 may include transmitting a smart contract identifier to packaging device 126.

[0247] The coordination system 108 instructs the input device 112 to notify the physician that they need to transfer the biological material (collected sperm cells) to the selected packaging device 126 (eg, via instructions displayed on the user interface 116).

[0248] Coordination system 108 then determines that subprocess 2.4 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 2.5, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to subprocess 2.5, in the same manner as described in Example 1 above.

[0249] Based on the current state of sub-process 2.5, coordination system 108 queries data storage location 114 to retrieve executable instructions. This, in this example, causes processor 110 to request packaging device 126 to initiate monitoring of sensor 308 and provide monitoring information to coordination system 108. The monitoring information is generated from monitoring data captured by sensor 308 of packaging device 126. In this example, the monitoring information includes temperature monitoring information and location tracking information. The temperature monitoring information indicates the temperature of the biomaterial within packaging device 126 and is generated from monitoring data from the temperature sensor. The location tracking information indicates the location of packaging device 126 (and the biomaterial) and is generated from monitoring data from a location sensor (e.g., a GPS sensor). Through the monitoring information, coordination system 108 also receives identification information including a smart contract identifier. The identification information may also include a packaging device identifier for packaging device 126.

[0250] The initiated monitoring continues until a termination condition defined in the executable instructions is met. The termination condition can be, for example, a period of time (e.g., four hours), the current state of smart contract 124 being a particular sub-process (e.g., sub-process 3.2), or the coordination system 108 receiving certain status information (e.g., receiving the required screening results at sub-process 3.1). When coordination system 108 receives the monitoring information and identification information, it uses the smart contract identifier to query the blockchain and retrieve the smart contract 124 for the current ART process, including the current state of that smart contract 124. Based on the retrieved smart contract 124 and the current state of sub-process 2.5, coordination system 108 queries data storage location 114 to retrieve the executable instructions for sub-process 2.5, which, when executed, cause processor 110 to process the received monitoring information. Processing includes verification by coordination system 108 of the monitoring information to determine whether the received temperature monitoring information and location tracking information meet predefined transition conditions. For example, the temperature monitoring information may need to be within a certain range required to maintain the viability of the biological material within packaging equipment 126. If the verification is unsuccessful, coordination system 108 may send an alert to the physician via input device 112 and user interface 116. If the verification is successful, coordination system 108 determines a portion of the monitoring information to be stored on the blockchain. For example, if the temperature monitoring information includes temperature measurements taken every second, coordination system 108 may determine that measurements taken every minute are to be stored on the blockchain. After processing, coordination system 108 stores the portion of the monitoring information on the blockchain (using the same steps described in Example 1 above).

[0251] As described above, coordination system 108 may store a copy of all received monitoring information in data lake 128 .

[0252] As described above, the packaging device 126 may store a copy of the monitoring information locally to the packaging device's data store 306. The coordination system 108 may receive the local copy of the monitoring information at a later stage, for example, for data integrity or data recovery purposes.

[0253] After initiating monitoring, the coordination system 108 determines that sub-process 2.5 is complete, although the initiated monitoring process will continue after Milestone 2 is completed until the termination condition is met. Milestone 3

[0254] like Figure 24A and 24B As shown, the third milestone of this example is "Sample Preparation." At this milestone, medical scientists prepare the biological material (collected semen sample) in preparation for cryopreservation.

[0255] Based on the current state being sub-process 3.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.1, which in this example causes processor 110 to perform the following operations.

[0256] In subprocess 3.1, coordination system 108 instructs input device 112′ (which may be different from input device 112) to notify the medical scientist that they need to enter status information for screening results of the biological material (e.g., via instructions displayed on user interface 116′ associated with input device 112′). The required screening results may include the results of one or more disease or infection tests performed on the biological material, such as the results of an HIV test performed on the biological material. User interface 116′ receives input from the medical scientist identifying the screening results. While in this example, the screening results are entered by a physician using user interface 116′, in other examples, the screening results may be received by coordination system 108 from one or more devices 102 (e.g., one or more in vitro diagnostic devices). Input device 112′ transmits this input to coordination system 108, which processes the input status information. Processing includes coordination system 108 validating the status information to determine whether the received screening results meet predefined transition conditions. For example, a semen sample may require certain screening results before use (e.g., due to regulatory requirements). If the verification is unsuccessful, coordination system 108 may send an alert to the medical scientist via input device 112' and / or user interface 116'. If the verification is successful, coordination system 108 determines at least a portion of the screening results to be stored on the blockchain. After processing, coordination system 108 stores the portion of monitoring information (screening results) on the blockchain (using the same steps as in Example 1 above). Coordination system 108 then receives confirmation from the gatekeeper component that the data has been stored on the blockchain and determines that subprocess 3.1 has been completed. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 3.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 3.2, in the same manner as described in Example 1 above.

[0257] Based on the current state being sub-process 3.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.2, which in this example causes processor 110 to perform the following operations.

[0258] In sub-process 3.2, coordination system 108 instructs input device 112′ to notify the medical scientist that they need to input status information related to genetic testing that the medical scientist is performing on the biological material using input device 112′ (e.g., via instructions displayed on user interface 116′). For example, the genetic testing may include testing for characteristics such as eye color, skin color, and / or height.

[0259] Coordination system 108 receives state information input by the medical scientist via user interface 116' from input device 112'. Using this state information, coordination system 108 also receives identification information including a smart contract identifier. Using this identification information, coordination system 108 queries the blockchain to retrieve smart contract 124 and the current state of smart contract 124. Based on the retrieved current state being sub-process 3.2, coordination system 108 queries data storage location 114 to retrieve executable instructions, which coordination system 108 executes to process the state information. Processing includes validating the state information to determine whether the input information meets predefined transition conditions. For example, the transition conditions may be defined in the executable instructions based on one or more predetermined requirements for the genetic test results. If validation is unsuccessful, coordination system 108 marks the state information invalid to indicate that it failed validation and instructs input device 112' to notify the medical scientist of the validation failure.

[0260] The processing also includes the coordination system 108 determining a portion of the state information to be stored on the blockchain (where the portion may include all of the state information). The coordination system 108 may store a copy of the received state information in the data lake 128. After the processing is complete, the coordination system 108 stores the determined portion of the state information on the blockchain (using the same steps described in Example 1 above).

[0261] Coordination system 108 then determines that subprocess 3.2 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 3.3.1, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to subprocess 3.3.1, in the same manner as described above for subprocess 1.1.

[0262] Based on the current state being sub-process 3.3.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.3.1, which in this example causes processor 110 to perform the following operations.

[0263] In subprocess 3.3.1, coordination system 108 instructs input device 112' to notify the medical scientist that they need to input status information related to the pre-analytical preparation performed by the medical scientist on the biological material in preparation for subsequent analysis in subprocess 3.3.2 (e.g., via instructions displayed on user interface 116'). Pre-analytical preparation can include processes such as centrifugation, addition of culture medium, and taking one or more baseline measurements (e.g., cell count, cell viability, and / or cell functionality). User interface 116' receives input from the medical scientist identifying the pre-analytical preparation, and input device 112' transmits the input to coordination system 108, which processes the pre-analytical preparation information and then stores it on the blockchain in the same manner as described in Example 1 above.

[0264] Coordination system 108 then receives confirmation from the gatekeeper component that the data has been stored on the blockchain, and determines that sub-process 3.3.1 has been completed. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.3.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.3.2, in the same manner as described in Example 1 above.

[0265] Based on the current state being sub-process 3.3.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.3.2, which in this example causes the processor to perform the following operations.

[0266] In subprocess 3.3.2, coordination system 108 instructs input device 112′ to notify the medical scientist that they need to use input device 112′ to input status information related to the analysis performed on the biological material and the corresponding analysis results (e.g., via instructions displayed on user interface 116′). For example, the analysis related to the application may include determining the motility of sperm cells and determining the grade of sperm cells.

[0267] User interface 116′ receives input from a medical scientist, identifying analysis steps and results. While in this example, the input is received from user interface 116′, in other examples, the input may be received from one or more devices performing biological material analysis, each of which is part of multiple devices 102. Input device 112′ transmits this input to coordination system 108, which processes the input status information. Processing includes coordination system 108 validating the analysis steps and results to determine whether they are valid for smart contract 124—that is, whether the steps and results meet predefined criteria (or "transition conditions") defined by the executable instructions. If validation is successful, coordination system 108 determines at least a portion of the analysis steps and results to be stored on the blockchain. If validation is unsuccessful, coordination system 108 instructs input device 112′ to notify the medical scientist of the unsuccessful validation and request new input. Coordination system 108 may store a copy of the received status information in data lake 128. After processing, coordination system 108 stores the determined portion of the status information on the blockchain (using the same steps described in Example 1 above).

[0268] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that sub-process 3.3.2 is complete. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.3.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.3.3, in the same manner as described in Example 1 above.

[0269] Based on the current state being sub-process 3.3.3, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions for sub-process 3.3.3, which in this example causes processor 110 to perform the same steps as described for sub-process 3.2.1 in Example 1. When coordination system 108 recognizes that sub-process 3.3.3 has completed, smart contract 124 indicates that the next sub-process to be implemented is sub-process 3.3.4. Therefore, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.3.4, in the same manner as described in Example 1 above.

[0270] Based on the current sub-process being sub-process 3.3.4, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions for sub-process 3.3.4, which in this example causes processor 110 to perform the same steps as described for sub-process 8.3 in Example 1. When coordination system 108 recognizes that sub-process 3.3.4 has completed, smart contract 124 indicates that the next sub-process to be implemented is sub-process 3.3.5. Therefore, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.3.5, in the same manner as described in Example 1 above.

[0271] Based on the current state being sub-process 3.3.5, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.3.5, which in this example causes processor 110 to perform the following operations.

[0272] In subprocess 3.3.5, coordination system 108 selects an appropriate packaging facility 126' for the biological material, which has undergone pre-cryopreservation processing at this stage. This selection, according to executable instructions, may be based on the volume of biological material received in subprocess 2.3 and / or the pre-cryopreservation processing steps received in subprocess 3.3.1. Coordination system 108 generates a packaging facility identifier for selected packaging facility 126'. Coordination system 108 stores the selection of packaging facility 126' (including the packaging facility identifier) on the blockchain in the same manner as described above, and subsequently receives confirmation from the gatekeeper component that the data has been stored on the blockchain. Coordination system 108 notifies selected packaging facility 126' that it has been selected for the current ART process. Notifying packaging facility 126' may include transmitting the smart contract identifier to packaging facility 126'. In this example, packaging facility 126' is different from packaging facility 126 selected in subprocess 2.4, but in some examples, packaging facility 126' may be the same as packaging facility 126.

[0273] The coordination system 108 instructs the input device 112' to notify the physician that they need to transfer the biological material (collected sperm cells) to the selected packaging device 126' (eg, via instructions displayed on the user interface 116').

[0274] Coordination system 108 then recognizes that sub-process 3.3.5 has completed. Since smart contract 124 specifies that the next sub-process to be implemented is sub-process 3.3.6, coordination system 108 writes to the distributed ledger to update the current state of smart contract 124 to sub-process 3.3.6, in the same manner as described in Example 1 above.

[0275] Based on the current sub-process being sub-process 3.3.6, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions for sub-process 3.3.6, which, in this example, causes processor 110 to perform the same steps as described for sub-process 3.2.5 in Example 1. When coordination system 108 recognizes that sub-process 3.3.6 has completed, smart contract 124 indicates that the next sub-process to be implemented is sub-process 3.3.7. Therefore, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 3.3.7, in the same manner as described in Example 1 above.

[0276] Based on the current sub-process being sub-process 3.3.7, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 3.3.7, which in this example causes processor 110 to perform the same steps as described for sub-process 3.2.6 in Example 1.

[0277] When coordination system 108 determines that Milestone 3 and Sub-Process 3.3.7 have been completed, smart contract 124 indicates that the next milestone and sub-process to be achieved are Milestone 4 and Sub-Process 4.1, so coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 4 Sub-Process 4.1, in the same manner as described in Example 1 above. Milestone 4

[0278] like Figure 25 As shown, the fourth milestone of this example is "controlled preservation." At this milestone, the medical scientist places the packaging device 126 into a cryopreservation device that freezes the biological material in the packaging device 126 at a controlled rate.

[0279] Subprocess 4.1 is performed in the same manner as described in subprocess 3.2.3 of Example 1 above, but a request to initiate monitoring is sent to the cryopreservation device. The cryopreservation device generates monitoring information based on the monitoring data captured by its sensor 208. In subprocess 4.1, the monitoring information may include temperature monitoring information (i.e., information about the temperature during cryopreservation) and operation monitoring information. The temperature monitoring information indicates the temperature of the biological material inside the packaging device 126 and is generated based on the monitoring data of the temperature sensor. The operation monitoring information indicates one or more operations performed by the cryopreservation device, such as the speed of the heat exchange fluid. Via the monitoring information, the coordination system 108 also receives identification information including a smart contract identifier. The identification information may also include a device identifier associated with the cryopreservation device.

[0280] The initiated monitoring continues throughout Milestone 4, i.e., while sub-process 4.2 is being executed. When coordination system 108 receives the monitoring information and identification information, it uses the smart contract identifier to query the blockchain and retrieve the smart contract 124 for the current ART process, including the current state of smart contract 124. Based on the retrieved smart contract 124 and the current state (which may be sub-process 4.2 at this point), coordination system 108 queries data storage location 114 to retrieve the executable instructions for that sub-process. Execution of these instructions causes processor 110 to process the received monitoring information. Processing involves coordination system 108 validating the state information to determine whether the received temperature monitoring information and operational monitoring information meet predefined transition conditions. For example, operational monitoring information may need to be within a specific range to confirm that no operational failures or other unforeseen events have occurred within the cryopreservation device. If the validation is unsuccessful, coordination system 108 may send an alert to the medical scientist via input device 112' and user interface 116'. If the validation is successful, coordination system 108 determines the portion of the monitoring information to be stored on the blockchain. For example, if the operation monitoring information includes monitoring information for multiple operations performed by the cryopreservation device, the coordination system 108 may determine that only the monitoring information for certain operations should be stored on the blockchain. After processing, the coordination system 108 stores a portion of the monitoring information on the blockchain (using the same steps described in Example 1 above).

[0281] Processing the operation monitoring information may also include generating cost monitoring information based on the operation monitoring information, the cost monitoring information indicating the costs associated with operating the cryopreservation device to perform cryopreservation of biological materials; determining a portion of the cost monitoring information to be stored on the blockchain; and storing the portion of the cost monitoring information to the blockchain (using the same steps as described in Example 1 above).

[0282] After initiating monitoring, coordination system 108 recognizes that subprocess 4.1 has completed, even though the initiated monitoring will continue throughout the milestone. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 4.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 4.2, in the same manner as described in Example 1 above.

[0283] Based on the current state being sub-process 4.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 4.2, which in this example causes processor 110 to perform the following operations.

[0284] In sub-process 4.2, the coordination system 108 controls the cryopreservation device to adjust its refrigeration system to achieve the desired operating conditions according to the cryopreservation protocol received at milestone 3. It does this by determining one or more commands or one or more executable instructions and transmitting the commands or executable instructions to the cryopreservation device, which executes the commands or executable instructions to control the functions of its refrigeration system.

[0285] Coordination system 108 recognizes that sub-process 4.2 has been completed by determining, for example, based on operational monitoring information, that the cryopreservation device has met the operational conditions required by the cryopreservation protocol (selected in sub-process 3.3.7). Because smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 5 and Sub-process 5.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 5 and Sub-process 5.1, in the same manner as described in Example 1 above. Milestone 5

[0286] like Figure 26 As shown, the fifth milestone of this example is "Specialized Logistics." At this milestone, the biological material within packaging facility 126 is maintained in a controlled and monitored environment while being transported between the locations at milestones 2-4 and the location at milestone 6.

[0287] Based on the current state of sub-process 5.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 5.1. In this example, the instructions cause processor 110 to request packaging device 126 to initiate monitoring by sensor 308 and provide monitoring information to coordination system 108. The monitoring information is generated from monitoring data captured by sensor 308 of packaging device 126. In this example, the monitoring information includes temperature monitoring information and location tracking information. The temperature monitoring information indicates the temperature of the biomaterial within packaging device 126 and is generated from monitoring data from the temperature sensor. The location tracking information indicates the location of packaging device 126 (and the biomaterial) and is generated from monitoring data from a location sensor (e.g., a GPS sensor). Through the monitoring information, coordination system 108 also receives identification information including a smart contract identifier. The identification information may also include a packaging device identifier for packaging device 126.

[0288] The initiated monitoring continues throughout Milestone 5, i.e., while sub-process 5.2 is being executed. When coordination system 108 receives the monitoring information and identification information, it uses the smart contract identifier to query the blockchain and retrieve the smart contract 124 for the current ART process, including the current state of smart contract 124. Based on the retrieved smart contract 124 and the current state (which may be sub-process 5.2), coordination system 108 queries data storage location 114 to retrieve the executable instructions for the sub-process. These instructions, when executed, cause processor 110 to process the received monitoring information. Processing includes verification by coordination system 108 of the monitoring information to determine whether the received temperature monitoring information and location tracking information meet predefined transition conditions. For example, the temperature monitoring information may need to be within a certain range required to maintain the biological material within packaging equipment 126. If verification is unsuccessful, coordination system 108 may send an alert to the medical scientist via input device 112' and user interface 116'. If verification is successful, coordination system 108 determines the portion of the monitoring information to be stored on the blockchain. For example, if the temperature monitoring information includes temperature measurements taken every second, the coordination system 108 may determine that measurements taken once every minute are to be stored on the blockchain. After processing, the coordination system 108 stores a portion of the monitoring information on the blockchain (using the same steps described in Example 1 above).

[0289] As described above, coordination system 108 may store a copy of all received monitoring information in data lake 128 .

[0290] As described above, the packaging device 126 may store a copy of the monitoring information locally in the packaging device's data store 306. The coordination system 108 may receive the local copy of the monitoring information at a later stage, for example, for data integrity or data recovery purposes.

[0291] After initiating monitoring, coordination system 108 determines that subprocess 5.1 is complete, even though the initiated monitoring process will continue throughout the milestone. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 5.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 5.2, in the same manner as described in Example 1 above.

[0292] Based on the current state being sub-process 5.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 5.2, which in this example causes processor 110 to perform the following operations.

[0293] In subprocess 5.2, coordination system 108 determines a target destination for the biological material within packaging facility 126. In this example, the target destination corresponds to the location of a thawing device, which is predefined and stored on the blockchain. Based on the location tracking information received and stored as a result of the monitoring initiated at subprocess 5.2, coordination system 108 can also determine a route (e.g., an optimal route) to reach the target destination.

[0294] Once the coordination system 108 processes the request, it transmits the target destination to the secure API, which in turn transmits the target destination to the packaging device 126.

[0295] Coordination system 108 receives confirmation from packaging equipment 126 that the target destination has been received. Coordination system 108 then determines that sub-process 5.2 and milestone 5 are complete. Because smart contract 124 specifies that the next milestone and sub-process to be achieved are milestone 6 and sub-process 6.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to milestone 6 and sub-process 6.1, in the same manner as described in Example 1 above. Milestone 6

[0296] like Figure 27 As shown, the sixth milestone of this example is "controlled biothawing". At this milestone, the thawing device thaws the cryopreserved biological material in preparation for post-thawing processing at milestone 7 and application use at milestone 8.

[0297] Subprocess 6.1 is executed in the same manner as subprocess 4.1 above, except that a request to initiate monitoring is sent to the thawing device. The thawing device generates monitoring information based on the monitoring data captured by its sensor 208. In subprocess 6.1, the monitoring information may include temperature monitoring information (i.e., monitoring the temperature during cryopreservation) and operational monitoring information. The temperature monitoring information indicates the temperature of the biological material within the packaging device 126 and is generated based on the monitoring data from the temperature sensor. The operational monitoring information indicates one or more operations performed by the thawing device, such as the thawing temperature applied by the device.

[0298] The initiated monitoring continues throughout Milestone 6, i.e., while sub-processes 6.2 and 6.3 are executed. After initiating monitoring, coordination system 108 determines that sub-process 6.1 has completed, even though the initiated monitoring will continue throughout the milestone. Because smart contract 124 specifies that the next sub-process to be implemented is sub-process 6.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 6.2, in the same manner as described in Example 1 above.

[0299] Based on the current state being sub-process 6.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 6.2, which in this example causes processor 110 to perform the following operations.

[0300] In sub-process 6.2, the coordination system 108 receives status information in the form of a selected thawing protocol for thawing the biological material in the packaging device. The thawing protocol defines the thawing settings of the thawing device, including the heating rate and temperature of the thawing process.

[0301] The cryopreservation device receives status information from the thawing device via a secure API. The cryopreservation device may select a thawing protocol based on one or more of the following factors: the type of packaging device 126, the type of biological material (i.e., sperm cells in this example), the volume of the biological material (e.g., the number of cells), and the storage temperature of the biological material within the packaging device 126 since cryopreservation.

[0302] Coordination system 108 processes the received state information by validating it and determining that it should be stored on the blockchain, then writes to the blockchain to store the state information (using the same steps described above in subprocess 1.1). Coordination system 108 then determines that subprocess 6.2 has completed. Since smart contract 124 specifies that the next subprocess to be completed is subprocess 6.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 6.3, in the same manner as described above in Example 1.

[0303] Alternatively, in sub-process 6.2, the coordination system 108 receives a request from the thawing device through a secure API to obtain a selection of a thawing plan for thawing the biological material in the packaging device 126, including a heating rate and temperature of the thawing process.

[0304] The coordination system 108 processes the received request by confirming that the unfrozen device is one of the plurality of devices 102 and is therefore authorized to interact with the coordination system, and confirming the current state of the smart contract by querying the blockchain using the smart contract identifier.

[0305] Once coordination system 108 processes the request, it invokes a query process on the blockchain via the gatekeeper component. The gatekeeper component executes a query on the blockchain to obtain the required information, namely, the selected thawing solution for the current process. The blockchain query data results containing the required information are returned from the blockchain to coordination system 108 via the gatekeeper component. Coordination system 108 processes the blockchain query data results and then transmits them to the thawing device via a secure API. The thawing device uses the thawing solution received at subprocess 6.3 to thaw the biological material in packaging device 126.

[0306] Coordination system 108 receives confirmation from the thawing device that the selected thawing solution has been received. Coordination system 108 then determines that subprocess 6.2 has been completed. Because smart contract 124 specifies that the next subprocess to be completed is subprocess 6.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 6.3, in the same manner as described in Example 1 above.

[0307] Based on the current state being sub-process 6.3, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 6.3, which in this example causes processor 110 to perform the following operations.

[0308] In subprocess 6.3, coordination system 108 controls the thawing device to adjust its refrigeration system to achieve the required operating conditions according to the thawing plan received in subprocess 6.2. Coordination system 108 determines that subprocess 6.3 has been completed by determining (for example, based on operational monitoring information) that the thawing device has met the required operating conditions of the thawing plan (received in subprocess 6.2). Because smart contract 124 specifies that the next milestone and subprocess to be achieved are Milestone 7 and Subprocess 7.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 7 and Subprocess 7.1, in the same manner as described in Example 1 above. Milestone 7

[0309] like Figure 28 As shown, the seventh milestone in this example is "Post-Thaw Processing." At this milestone, the thawed biological material is analyzed and screened before the thawed sperm cells are used in the ART procedure at milestone 8.

[0310] Based on the current state being sub-process 7.1, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.1, which in this example causes processor 110 to perform the following operations.

[0311] In subprocess 7.1, the coordination system 108 instructs the input device 112" (which may be different from the input devices 112 and 112') to notify the medical scientists performing the analysis and screening steps that they need to input status information related to the analysis steps performed on the thawed biological material and the corresponding analysis results. For example, the required information may include: a measurement of sperm cell motility, a sperm count of the sperm cells, and / or the results of a sperm DNA fragmentation test. The instructions can be provided by displaying the instructions on the user interface 116" associated with the input device 112".

[0312] The user interface 116" receives input from the medical scientist, identifying the analysis steps and results. The input device 112" transmits this input to the coordination system 108, which processes the input state information. The processing includes the coordination system 108 validating the analysis steps and results to determine whether they are valid for the smart contract 124 - that is, whether the steps and results meet the predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is successful, the coordination system 108 determines at least a portion of the analysis steps and results to be stored on the blockchain. If the validation is unsuccessful, the coordination system 108 instructs the input device 112" to notify the medical scientist of the unsuccessful validation and request new input. The coordination system 108 can store a copy of the received state information in the data lake 128. After processing, the coordination system 108 stores the determined portion of the state information to the blockchain (using the same steps described in Example 1 above).

[0313] After receiving confirmation from the gatekeeper that the data has been stored on the blockchain, coordination system 108 determines that subprocess 7.1 is complete. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 7.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 7.2, in the same manner as described in Example 1 above.

[0314] Based on the current state being sub-process 7.2, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.2, which in this example causes processor 110 to perform the following operations.

[0315] In sub-process 7.2, coordination system 108 instructs input device 112″ to notify the medical scientist that they need to enter status information of the screening results of the thawed biological material (e.g., via instructions displayed on user interface 116″). Sub-process 7.2 is performed in the same manner as sub-process 3.1 above, but with respect to the thawed biological material. After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that sub-process 7.2 is complete. Because smart contract 124 stipulates that the next sub-process to be implemented is sub-process 7.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to sub-process 7.3, in the same manner as described in Example 1 above.

[0316] Based on the current state being sub-process 7.3, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.3, which in this example causes processor 110 to perform the following operations.

[0317] In sub-process 7.3, the coordination system 108 instructs the input device 112″ to notify the medical scientist that they need to input status information related to further analysis steps of the thawed biological material, analysis related to the application at milestone 8, and corresponding analysis results. For example, the analysis related to the application may include determining the motility of sperm cells and determining the grade of sperm cells. The instructions can be provided by displaying the instructions on the user interface 116″ associated with the input device 112″.

[0318] The user interface 116" receives input from the medical scientist, identifying the analysis steps and results. The input device 112" transmits this input to the coordination system 108, which processes the inputted state information. The processing includes the coordination system 108 validating the analysis steps and results to determine whether they are valid for the smart contract 124 - that is, whether the steps and results meet the predefined criteria (or "transition conditions") defined by the executable instructions. If the validation is successful, the coordination system 108 determines at least a portion of the analysis steps and results to be stored on the blockchain. If the validation is unsuccessful, the coordination system 108 instructs the input device 112" to notify the medical scientist of the unsuccessful validation and to request new input. The coordination system 108 may store a copy of the received state information in the data lake 128. After processing, the coordination system 108 stores the determined portion of the state information to the blockchain (using the same steps described in Example 1 above).

[0319] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that subprocess 7.3 is complete. Because smart contract 124 specifies that the next subprocess to be implemented is subprocess 7.4, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 7.4, in the same manner as described in Example 1 above.

[0320] Based on the current state being sub-process 7.4, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.4, which in this example causes processor 110 to perform the following operations.

[0321] In sub-process 7.4, the coordination system 108 instructs the input device 112″ to notify the medical scientist that they need to input status information related to the post-thaw processing performed on the biological material by the medical scientist using the input device 112″ (e.g., via instructions displayed on the user interface 116″). The post-thaw processing may include any processing required before the thawed sperm cells can be used for application in Milestone 8, such as removing cryoprotectants, diluting the sperm cells, and any other preparation required for performing a specific ART procedure (e.g., IUI or ICSI) on the sperm cells. Preparation for the specific ART procedure may include, for example, preparing relevant equipment, diluting the biological material to a specific dilution factor, and measuring relevant volumes of the biological material. The user interface 116″ receives the input from the medical scientist, identifies the post-thaw processing, and the input device 112″ transmits the input to the coordination system 108, which processes the post-thaw processing information and then stores it in the blockchain in the same manner as described in Example 1 above.

[0322] Coordination system 108 then receives confirmation from the gatekeeper that the data has been stored on the blockchain and determines that subprocess 7.4 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 7.5, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 7.5, in the same manner as described in Example 1 above.

[0323] Based on the current state being sub-process 7.5, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.5, which in this example cause processor 110 to perform the following operations.

[0324] In subprocess 7.5, coordination system 108 instructs input device 112 to notify the medical scientist that they need to reinsert the biological material (in this stage, the thawed sperm cells that have undergone post-thaw processing) into packaging device 126. Coordination system 108 determines that the biological material will be stored in packaging device 126 at the holding temperature until the biological material is needed for application, and requests packaging device 126 to initiate monitoring by sensor 308 and provide monitoring information to coordination system 108. The holding temperature can include a range of acceptable temperatures. The temperature monitoring information is generated in the same manner as described in subprocess 3.2.3 of Example 1. The initiated monitoring will continue for the remainder of milestone 7, that is, when subprocess 7.6 is executed, in the same manner as described in subprocess 3.2.3 of Example 1, and coordination system 108 stores the relevant determined monitoring information portion to the blockchain (using the same steps as described above in Example 1).

[0325] Therefore, if any temperature monitoring information falls outside the maintained temperature range, coordination system 108 generates an alert. Coordination system 108 then determines that subprocess 7.5 has been completed. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 7.6, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 7.6, in the same manner as described in Example 1 above.

[0326] Based on the current state being sub-process 7.6, coordination system 108 queries data storage location 114 to retrieve the executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 7.6, which in this example causes processor 110 to perform the following operations.

[0327] In sub-process 7.6, coordination system 108 instructs input device 112″ to notify the medical scientist that they need to input status information related to whether the excess portion of the biological material needs to be further cryopreserved, for example, for subsequent further processing. The medical scientist will determine whether there is any excess portion of the biological material (i.e., excess sperm cells that are not required for the application in Milestone 8) and whether the excess portion is to be cryopreserved for subsequent ART use. User interface 116″ receives input from the medical scientist to determine whether the excess portion of the biological material will be further cryopreserved, and input device 112″ transmits the input to coordination system 108, which processes the information and then stores it in the blockchain in the same manner as described in Example 1 above.

[0328] Coordination system 108 then receives confirmation from the gatekeeper that the data has been stored on the blockchain and determines that Milestone 7 and Sub-Process 7.6 are complete. Since smart contract 124 specifies that the next milestone and sub-process to be achieved are Milestone 8 and Sub-Process 8.1, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to Milestone 8 and Sub-Process 8.1, in the same manner as described in Example 1 above. Milestone 8

[0329] like Figure 29 As shown, the eighth milestone of this example is "applied use." At this milestone, at least a portion of the thawed biological material is used for an ART procedure, such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), or intrauterine insemination (IUI).

[0330] Based on the current state being sub-process 8.1, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.1, which in this example causes processor 110 to perform the following operations.

[0331] In subprocess 8.1, coordination system 108 instructs input device 112 to notify the physician (or other medical professional who will be performing or overseeing the ART procedure) that they need to provide status information in the form of physician details (identifying the physician), patient details (identifying the ART patient), and biomaterial details (identifying the biomaterial within packaging device 126). Input device 112 may provide instructions to the physician via user interface 116. The physician enters the details using user interface 116, and input device 112 transmits the entered status information to coordination system 108. Coordination system 108 processes the received status information. Processing includes validating the status information to determine whether the physician details, patient details, and biomaterial are valid for smart contract 124. In this example, validation may include querying the blockchain to check whether the biomaterial matches the corresponding biomaterial stored on the blockchain. If validation is successful, coordination system 108 determines that the entered physician details, patient details, and biomaterial will be stored on the blockchain. If validation is unsuccessful, coordination system 108 instructs the input device to notify the physician of the unsuccessful validation and request new input. Coordination system 108 may store a copy of the received status information in data lake 128. After processing, the coordination system 108 stores the state information to the blockchain (using the same steps described in Example 1 above).

[0332] After receiving confirmation from the gatekeeper component that the data has been stored on the blockchain, coordination system 108 determines that subprocess 8.1 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 8.2, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 8.2, in the same manner as described in Example 1 above.

[0333] Based on the current state being sub-process 8.2, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.2, which in this example causes processor 110 to perform the following operations.

[0334] In subprocess 8.2, coordination system 108 instructs input device 112 to notify the physician that the physician and / or patient need to provide security check information for the biomaterials used in the ART procedure. The security check information may include a password and / or biometric information (e.g., a retinal or fingerprint scan) to confirm the physician's and / or patient's identity. Input device 112 provides instructions to the physician via user interface 116. The physician and / or patient (as needed) enters the details using user interface 116 (which may be configured to capture biometric information), and input device 112 transmits status information of the input to coordination system 108. Coordination system 108 processes the received status information. Processing includes verifying the status information to determine whether the security check information is valid for smart contract 124. If the verification is successful, coordination system 108 determines that the verification success is to be stored on the blockchain. If the verification is unsuccessful, coordination system 108 instructs the input device to notify the physician of the verification failure and request new input, and determines that the verification failure is to be stored on the blockchain. After processing, coordination system 108 stores the verification success or failure on the blockchain (using the same steps described in Example 1 above).

[0335] After receiving confirmation from the gatekeeper that the data has been stored on the blockchain, coordination system 108 determines that subprocess 8.2 is complete. Since smart contract 124 specifies that the next subprocess to be implemented is subprocess 8.3, coordination system 108 writes to the blockchain to update the current state of smart contract 124 to subprocess 8.3, in the same manner as described in Example 1 above.

[0336] Based on the current state being sub-process 8.3, coordination system 108 queries data storage location 114 to retrieve executable instructions. In response, coordination system 108 receives and executes the executable instructions of sub-process 8.3, which in this example causes processor 110 to perform the following operations.

[0337] In subprocess 8.3, coordination system 108 instructs input device 112 to notify the physician to perform the ART procedure, for example, by displaying a message on user interface 116. Coordination system 108 then recognizes that milestone 8, subprocess 8.3, and the entire ART process defined by smart contract 124 are complete.

[0338] Reference in this specification to any previous publication (or information derived therefrom) or any known matter should not be taken as, and should not be taken as, an admission or endorsement or any form of implication that the previous publication (or information derived therefrom) or known matter forms part of the common general knowledge in the field to which this specification relates.

Claims

1. A method for controlling the processing of biological materials by a plurality of biological material processing devices, the method being implemented by a processor executing computer program instructions stored in a memory, and comprising the following steps: From one of the following: a first device of the plurality of devices, a device associated with a user interface for inputting data related to biological material, and Biomaterial packaging equipment, receiving status information of a biomaterial and identification information identifying a smart contract associated with the biomaterial; using the identification information to query a cryptographically secure distributed ledger to retrieve the smart contract associated with the biomaterial, including a current state of the smart contract; Based on the retrieved smart contract and the current state of the smart contract, querying a data storage location to retrieve executable instructions, wherein the data storage location is a non-secure distributed ledger; Execution of the executable instructions causes the processor to at least: processing the state information, wherein the processing comprises: verifying the status information, and determining a portion of the state information to be stored on the distributed ledger; and Writing to said distributed ledger to: storing the determined portion of the state information, and Updating the state of the smart contract.

2. The method according to claim 1, wherein Execution of the executable instructions further causes the processor to: The received status information is stored in the data lake.

3. The method according to any one of the preceding claims, wherein The status information includes monitoring information of the biological material.

4. The method according to claim 3, wherein: The monitoring information includes at least one of temperature monitoring information, position monitoring information, volume monitoring information and cell counting information.

5. The method according to any one of the preceding claims, wherein The status information includes information about one or more previous processing steps associated with the biological material.

6. The method of any one of the preceding claims, wherein The biological material includes at least one of the following: whole blood; blood components; stem cells; Modify cells; gamete; organs; and organize.

7. The method of any one of the preceding claims, wherein Execution of the executable instructions further causes the processor to: determining one or more commands or one or more computer-executable instructions to be executed by a second device of the plurality of devices; The commands or computer-executable instructions are transmitted to the second device.

8. The method according to claim 7, wherein: The command or the computer-executable instruction is used to control the second device, and the second device is one of the following: a cryopreservation device for cryopreserving the biological material; a thawing device for thawing the biological material; a transport device for transporting the biological material; a storage device for storing the biological material; A cell counting device for counting cells of the biological material.

9. The method of any one of the preceding claims, wherein At least one of the plurality of devices is configured to host at least one node of the distributed ledger.

10. The method according to claim 9, comprising: A determination is made that the second device has sufficient processing and storage capacity to host at least one node and execute the one or more commands or computer-executable instructions, and in response, the second device is allowed to host at least one node.

11. The method of any preceding claim, comprising: receiving historical status information and historical identification information from at least one of the first biological material processing apparatus and the biological material packaging device; comparing the historical state information and the historical identification information with previously received state information and identification information to determine whether the previously received state information should be updated using the historical state information; and In response to determining that the previously received state information should be updated using the historical state information, the previously received state information is updated by storing an additional entry on the distributed ledger recording the historical state information.

12. The method of any one of claims 1 to 8, comprising: receiving historical status information and the historical identification information from at least one of the first biomaterial processing apparatus and the biomaterial packaging device; Determining, based on the historical identification information, that the historical status information has not been received previously; and The historical status information is stored in the distributed ledger.

13. A method of controlling the processing of extracted biological material from its initial extraction to its final use, said processing involving a plurality of stages, said method comprising carrying out the method of any one of claims 1 to 7 at several of said plurality of stages.

14. The method according to claim 13, wherein The method of any one of claims 1 to 7 is performed in each of the plurality of stages.

15. A system for controlling the processing of biological materials, comprising: multiple biomaterial processing units; Coordinated systems, including: a processor for executing computer program instructions; and a memory for storing said computer program instructions for execution by said processor; a cryptographically secure distributed ledger for storing smart contracts associated with the biological material; and Data storage locations that are not secure distributed ledgers and are used to store retrievable computer-executable instructions; The computer program instructions stored in the memory include instructions that, when executed by the processor, cause the coordination system to: Receive status information of the biomaterial and identification information identifying the smart contract from one of the following: a first device of the plurality of devices, a device associated with a user interface for inputting data related to the biological material, and Biomaterial packaging equipment, querying a distributed ledger using the identification information to retrieve the smart contract and the current state of the smart contract; and querying a data storage location to retrieve computer-executable instructions based on the smart contract and the current state; and wherein the computer-executable instructions stored in the data storage location include instructions that, when executed by the processor, cause the coordination system to: The status information is processed in the following way: verifying the status information; and determining a portion of the state information to be stored on the distributed ledger; and Writing to the distributed ledger to store the determined portion of the state information and update the state of the smart contract.

16. A coordinated system for controlling the processing of biological materials, the coordinated system comprising: at least one processor; as well as A memory storing computer program instructions which, when executed by at least one processor, cause the coordination system to perform the method according to any one of claims 1 to 14.

17. A non-transitory, machine-readable storage medium having computer program instructions which, when executed by at least one processor of a coordination system, cause the coordination system to perform the method of any one of claims 1 to 14.

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