Systems and methods for automated chemical, manufacturing, and quality control (CMC) management

Abstract

Presented herein are systems and methods for automated data management for pharmaceutical product development and / or manufacturing. In certain embodiments, the automated data management systems and methods provide automated chemistry, manufacturing, and control (CMC) management. In one aspect, the invention relates to methods for using heterogeneous, structured data of an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells).

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 441,121, filed January 25, 2023, and U.S. Provisional Application No. 63 / 453,920, filed March 22, 2023, the contents of each of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE INVENTION The present invention relates generally to data management systems and methods. More specifically, in certain embodiments, the present invention relates to systems and methods for enterprise data management in pharmaceutical product development and / or manufacturing. [Background technology]

[0003] Chemistry, Manufacturing, and Controls (CMC) refers to activities performed in drug product development and manufacturing. CMC includes activities performed at all stages of the drug discovery cycle to ensure the quality and consistency of manufactured pharmaceutical products in accordance with regulatory guidance. CMC applies to both drug products and manufacturing facilities, providing continuity between the drug used in clinical trials and the drug that becomes commercially available to consumers. For example, CMC applies to drug manufacturing processes, quality control, formulation specifications, and drug product stability, as well as the design, qualification, operation, and maintenance of drug manufacturing facilities.

[0004] A variety of database management systems exist for process development and control. However, CMC presents significant challenges that render current database management systems inadequate, particularly for cell therapy manufacturing and development. Cell therapy manufacturing and clinical trials involve large amounts of data that must be analyzed quickly to drive insights. For example, database management systems need to provide real-time process visibility and trending. Cell therapy manufacturing involves many unit operations that generate large amounts of data with a variety of automated and digitized equipment. All of this data needs to be integrated in a consistent manner.

[0005] In particular, there is a need for more advanced database management systems that are particularly suited to managing heterogeneous, structured data generated by drug manufacturers, particularly for cell and tissue therapeutics such as CAR T-cell therapies and allogeneic transplants, as well as other biologics (e.g., blood components, nucleic acid-based therapies such as RNAi, gene therapy, and gene editing). Summary of the Invention [Means for solving the problem]

[0006] Presented herein are systems and methods for automated data management for pharmaceutical product development and / or manufacturing. Non-limiting examples of such pharmaceutical products include cell therapy products, such as natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells. In certain embodiments, automated data management systems and methods for automated chemistry, manufacturing, and quality control (CMC) management are provided.

[0007] In one aspect, the invention relates to a method of using heterogeneous, structured data of an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the method comprising: (a) receiving, by a processor of a computing device, a user query via a portal (e.g., a web-based portal), the query being related to: (i) design of a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operation (e.g., process monitoring and / or process control) of the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) a method of using heterogeneous, structured data of an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., a cell therapy product). (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing multiple data sources having heterogeneous data formats (e.g., via a federating server) and retrieving integrated results (e.g., combining data from the multiple sources to resolve one or more inconsistencies), the response to the user query including the integrated results; and (c) graphically rendering the response to the user query. In other embodiments, alternatives to a VDIS, such as a vertically integrated system and / or extract-transform-load (ETL) tool(s), may be used.

[0008] In certain embodiments, the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

[0009] In certain embodiments, step (c) includes updating a process monitoring graphical display (eg, a monitoring dashboard) with responses to user queries in real time (eg, near real time).

[0010] In certain embodiments, the multiple data sources accessed by the VDIS include live data (eg, data that is updated in real time).

[0011] In certain embodiments, step (c) includes graphically rendering a digital page containing multiple sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, which is updated to reflect responses to user queries (e.g., clinical interactive "stories" for communication and training).

[0012] In certain embodiments, the view-based data integration system includes a both-as-view (BAV) (also known as global and local as view (GLAV)) backend infrastructure.

[0013] In certain embodiments, the view-based data integration system includes a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure.

[0014] In particular embodiments, the mediator translates a user query into multiple source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates a response to the query.

[0015] In certain embodiments, the backend infrastructure includes multiple sources containing heterogeneous structured data that are integrated into a unified view.

[0016] In certain embodiments, the method uses a graph-based real-time digitization and contextualization engine.

[0017] In certain embodiments, the multiple data sources having disparate data formats accessed by the VDIS include at least one data source whose data is automatically reconciled at the time of data collection. In certain embodiments, the at least one data source automatically reconciles its data by restricting data entry to a number of predetermined fields and / or values.

[0018] In certain embodiments, step (c) includes graphically rendering a response to the user query via a graphical user interface (e.g., a process director display) that includes one or more linked blocks (e.g., types of graphical widgets, e.g., tiles), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is included in at least one of a plurality of data sources accessed by the VDIS, and one or more of the blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed that conveys additional data to the user regarding the process step represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0019] In certain embodiments, step (c) includes graphically rendering a response to the user query via a graphical user interface (e.g., a process designer) that includes one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is included in at least one of a plurality of data sources accessed by the VDIS, one or more blocks can be linked together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and one or more blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed that conveys additional data to the user regarding the unit operation represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0020] In certain embodiments, step (c) includes graphically rendering the response to the query via a graphical user interface (e.g., patient tiles) that includes a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of a plurality of data sources accessed by the VDIS (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and one or more tiles are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user about the subject represented by the particular tile, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0021] In certain embodiments, step (c) includes graphically rendering a response to the user query via a graphical user interface (eg, substantially as rendered in FIGS. 4A-34J).

[0022] In another aspect, the present invention relates to a method of using data from an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the method comprising: (a) receiving, by a processor of a computing device, a user query via a portal (e.g., a web-based portal), the query relating to one or more of: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (b) synthesizing the user query in a database. (c) communicating the data source information to a database management system to generate a response to the user query, wherein the database management system accesses multiple data sources (e.g., via a federating server) and retrieves results (e.g., combines data from the multiple sources and resolves one or more inconsistencies to generate an integrated result), the response to the user query including the results; and (c) graphically rendering the response to the user query, wherein the multiple data sources accessed by the database management system include at least one data source, the data of which is automatically reconciled at the time of data collection by restricting data entry to multiple predetermined fields and / or values.

[0023] In certain embodiments, the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

[0024] In certain embodiments, step (c) includes updating a process monitoring graphical display (eg, a monitoring dashboard) with responses to user queries in real time (eg, near real time).

[0025] In certain embodiments, the multiple data sources accessed by the database management system include live data (eg, data that is updated in real time).

[0026] In certain embodiments, step (c) includes graphically rendering a digital page containing multiple sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, which is updated to reflect responses to user queries (e.g., clinical interactive "stories" for communication and training).

[0027] In certain embodiments, the method uses a graph-based real-time digitization and contextualization engine.

[0028] In certain embodiments, step (c) includes graphically rendering a response to the user query via a graphical user interface (e.g., a process director display) that includes one or more linked blocks (e.g., types of graphical widgets, e.g., tiles), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is contained in at least one of a plurality of data sources accessed by the database management system, and one or more of the blocks being dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed that conveys additional data to the user regarding the process step represented by the particular block, the additional data being contained in at least one of a plurality of data sources accessed by the database management system.

[0029] In certain embodiments, step (c) comprises graphically rendering a response to the user query via a graphical user interface (e.g., a process designer) comprising one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is contained in at least one of a plurality of data sources accessed by the database management system, one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and one or more blocks being dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed conveying additional data to the user regarding the unit operation represented by the particular block, the additional data being contained in at least one of a plurality of data sources accessed by the database management system.

[0030] In certain embodiments, step (c) includes graphically rendering the response to the query via a graphical user interface (e.g., patient tiles) that includes a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of a plurality of data sources accessed by the database management system (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and one or more tiles are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user about the subject represented by the particular tile, the additional data being included in at least one of a plurality of data sources accessed by the database management system.

[0031] In certain embodiments, step (c) includes graphically rendering a response to the user query via a graphical user interface (eg, substantially as rendered in FIGS. 4A-34J).

[0032] In another aspect, the present invention relates to a system for using heterogeneous, structured data of companies in the development and / or manufacturing of pharmaceutical products (e.g., cell therapy products, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the system including a processor of a computing device and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receive a user query via a portal (e.g., a web-based portal), the query comprising: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) designing and manufacturing the pharmaceutical product. (b) receiving a user query relating to one or more of: (a) modeling a manufacturing process for manufacturing a cell therapy product; (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing multiple data sources having heterogeneous data formats (e.g., via a federating server) to retrieve integrated results (e.g., combining data from the multiple sources to resolve one or more inconsistencies), the response to the user query including the integrated results; and (c) graphically rendering the response to the user query. In other embodiments, alternatives to a VDIS, such as a vertically integrated system and / or extract transform load (ETL) tool(s), may be used.

[0033] In certain embodiments, the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

[0034] In particular embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to update the process monitoring graphical display (e.g., a monitoring dashboard) in response to user queries in real time (e.g., near real time).

[0035] In certain embodiments, the multiple data sources accessed by the VDIS include live data (eg, data that is updated in real time).

[0036] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a digital page including multiple sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, which is updated to reflect responses to user queries (e.g., clinical interactive "stories" for communication and training).

[0037] In certain embodiments, the view-based data integration system includes a both-as-view (BAV) (also known as global and local as view (GLAV)) backend infrastructure.

[0038] In certain embodiments, the view-based data integration system includes a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure.

[0039] In particular embodiments, the mediator translates a user query into multiple source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates a response to the query.

[0040] In certain embodiments, the backend infrastructure includes multiple sources containing heterogeneous structured data that are integrated into a unified view.

[0041] In certain embodiments, the system uses a graph-based real-time digitization and contextualization engine.

[0042] In certain embodiments, the multiple data sources having disparate data formats accessed by the VDIS include at least one data source whose data is automatically reconciled at the time of data collection. In certain embodiments, the at least one data source automatically reconciles its data by restricting data entry to a number of predetermined fields and / or values.

[0043] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to a user query via a graphical user interface (e.g., a process director display) that includes one or more linked blocks (e.g., types of graphical widgets, e.g., tiles), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is included in at least one of a plurality of data sources accessed by the VDIS, and one or more of the blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the process step represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0044] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to a user query via a graphical user interface (e.g., a process designer) that includes one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is included in at least one of a plurality of data sources accessed by the VDIS, one or more blocks can be linked together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and one or more blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user regarding the unit operation represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0045] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to the query via a graphical user interface (e.g., patient tiles) that includes a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of a plurality of data sources accessed by the VDIS (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and one or more tiles are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user about the subject represented by the particular tile, the additional data being included in at least one of a plurality of data sources accessed by the VDIS.

[0046] In particular embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to the user query via a graphical user interface (e.g., substantially as rendered in Figures 4A-34J).

[0047] In another aspect, the invention relates to a system for using data of an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the system including a processor of a computing device and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receive, by the processor of the computing device, a user query via a portal (e.g., a web-based portal), the query being related to: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling the manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product). (b) receiving a user query relating to one or more of the data sources; (b) communicating the user query to a database management system to generate a response to the user query, wherein the database management system accesses multiple data sources (e.g., via a federating server) and searches for results (e.g., combines data from the multiple sources and resolves one or more inconsistencies to generate an integrated result), the response to the user query including the results; and (c) graphically rendering the response to the user query, wherein the multiple data sources accessed by the database management system include at least one data source, the data of which is automatically reconciled at the time of data collection by restricting data entry to multiple predetermined fields and / or values.

[0048] In certain embodiments, the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

[0049] In particular embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to update the process monitoring graphical display (e.g., a monitoring dashboard) in response to user queries in real time (e.g., near real time).

[0050] In certain embodiments, the multiple data sources accessed by the database management system include live data (eg, data that is updated in real time).

[0051] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a digital page including multiple sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, which is updated to reflect responses to user queries (e.g., clinical interactive "stories" for communication and training).

[0052] In certain embodiments, the system uses a graph-based real-time digitization and contextualization engine.

[0053] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to a user query via a graphical user interface (e.g., a process director display) that includes one or more linked blocks (e.g., types of graphical widgets, e.g., tiles), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is included in at least one of a plurality of data sources accessed by the database management system, and one or more of the blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user regarding the process step represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the database management system.

[0054] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to a user query via a graphical user interface (e.g., a process designer) that includes one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is included in at least one of a plurality of data sources accessed by the database management system, one or more blocks that can be linked together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and one or more blocks that are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed that conveys additional data to the user regarding the unit operation represented by the particular block, the additional data being included in at least one of a plurality of data sources accessed by the database management system.

[0055] In certain embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to the query via a graphical user interface (e.g., patient tiles) that includes a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of a plurality of data sources accessed by the database management system (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and one or more tiles are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user about the subject represented by the particular tile, the additional data being included in at least one of a plurality of data sources accessed by the database management system.

[0056] In particular embodiments, the instructions, when executed by a processor, cause the processor (e.g., in step (c)) to graphically render a response to the user query via a graphical user interface (e.g., substantially as rendered in Figures 4A-34J).

[0057] In another aspect, the present invention is directed to a method for facilitating user management of a manufacturing process (e.g., an experimental (e.g., lab or pilot scale) process developed for / in the design of the manufacturing process; e.g., a commercial scale production process) for producing a pharmaceutical product (e.g., a cell therapy product, e.g., a biological agent) via an interactive manufacturing management graphical user interface (GUI), the method comprising: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a plurality of unit operations in the particular manufacturing process, the data representing (i) actions performed at the plurality of unit operations and / or (ii) information collected about the plurality of unit operations (e.g., before, during, and / or after one or more of the plurality of unit operations are performed); and rendering a graph-based visualization of the plurality of interactive nodes (e.g., graphical icons such as (e.g., color-coded) interconnected circular icons), each interactive node of the plurality of interactive nodes representing (i) an individual data point corresponding to a particular action performed in one of the plurality of unit operations and / or (ii) a particular set of information collected for a particular one of the plurality of unit operations (e.g., information collected before, during, and / or after the particular unit operation) (e.g., one or more of the interactive nodes are linked (e.g., connected to each other), with each link between a first and second interactive node representing a dependency and / or sequence of material and / or data flow (e.g., each link is graphically rendered as a line connecting two graphical nodes representing the nodes).

[0058] In certain embodiments, the graph-based visualization includes a timeline (e.g., vertical or horizontal lines, markings (e.g., labeled) along the line representing days and / or unit operations) showing days (e.g., days on which a particular manufacturing process is carried out) and / or unit operations (e.g., of a particular manufacturing process), and each interactive node of the plurality of interactive nodes is visually associated with a particular one of the days and / or unit operations in the timeline (e.g., positioned in proximity to and along the same horizontal and / or vertical axes as the particular day and / or unit operation within the graph-based visualization).

[0059] In certain embodiments, the graph-based visualization includes a base graph that corresponds to and represents a baseline version of the manufacturing process, along with one or more auxiliary sub-graphs, each sub-graph corresponding to and representing experimental conditions and / or variations of the baseline version of the manufacturing process (e.g., one or more auxiliary sub-graphs are displayed below the base graph (e.g., each auxiliary sub-graph includes one or more icons representing nodes and connecting lines representing links between the nodes, which in turn represent unit operations and materials and / or data flows between them, respectively)).

[0060] In certain embodiments, multiple interactive nodes are dynamic, such that upon user interaction with a particular interactive node (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed that conveys additional data to the user regarding the data point represented by the particular interactive node (e.g., the additional data is contained in at least one of multiple data sources accessed by the VDIS).

[0061] In certain embodiments, the method includes rendering a plurality of data point indicators for each of one or more data parameters and / or variables controlled and / or monitored during the particular manufacturing process, each data point indicator representing a collected and / or entered value of the data parameter and / or variable at a particular timepoint and / or unit operation during the particular manufacturing process.

[0062] In certain embodiments, the data point indicators are color coded according to whether data has been collected, is missing, and / or is selected for further analysis.

[0063] In particular embodiments, the method includes receiving, by a processor, via a GUI, a user selection of at least some of the data points (e.g., via a user click), and generating, by the processor, an interactive graph plotting values ​​of the selected data points.

[0064] In certain embodiments, the manufacturing process data includes multiple sets of values ​​for one or more data parameters and / or variables controlled and / or monitored during a particular manufacturing process, each set of values ​​associated with a separate lot and / or batch, and the interactive graph includes multiple traces (e.g., lines, a collection of points (e.g., as in a scatter plot), a series of bars (e.g., as in a bar graph), graphic icons (e.g., pictograms), etc.; e.g., as shown in any one of Figures 20A-28F), each trace corresponding to and showing the progression of a set of values ​​for the particular lot and / or batch with which the set is associated.

[0065] In certain embodiments, the method includes receiving and / or accessing, by the processor, additional manufacturing process data corresponding to one or more additional manufacturing processes; and causing the processor to render, by the processor, one or more additional graph-based visualizations, each representing a particular one of the one or more additional manufacturing processes within the manufacturing management GUI, wherein the one or more additional graph-based visualizations are aligned and / or overlaid with the graph-based visualization corresponding to the particular manufacturing process.

[0066] In certain embodiments, rendering one or more additional graph-based visualizations includes automatically highlighting deviations between one or more processes and / or deviations from norms (e.g., visually rendering nodes representing and / or lines connecting unit operations that (i) differ from those of other processes and / or have one or more parameters and / or collected data that (ii) deviate from normative values ​​and / or ranges of normative values).

[0067] In certain embodiments, the method includes generating and outputting a harmonized data set corresponding to a particular manufacturing process and one or more additional manufacturing processes (e.g., for subsequent mathematical modeling) (e.g., identifying data points that are consistent and / or outliers (e.g., automatically and / or based on user input and / or selection), and then extracting a portion of the data points (identified as consistent) to generate the harmonized data set).

[0068] In certain embodiments, the method includes receiving, by a processor, via a manufacturing management GUI, a user selection of one or more nodes to include in the harmonized dataset and / or user data input for one or more nodes of the graph-based visualization and / or one or more additional graph-based visualizations, and generating, by the processor, a harmonized dataset (e.g., a dataset in which the user-selected nodes and / or originally stored data have been replaced with the user input) based at least in part on the user selection and / or data input.

[0069] In another aspect, the present invention is directed to a method for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, the method including: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a particular manufacturing process and representing operations performed (e.g., unit operations in the particular manufacturing process) and / or information collected during the particular manufacturing process; and (b) causing the processor to graphically render, by the processor, one or more interactive panels representing operations during the manufacturing process and / or information collected during the manufacturing process, the one or more interactive panels including one or more (e.g., up to all) of the following: (i) a particular (ii) a real-time data display panel containing a graphical rendering of data obtained from and / or input to one or more connected devices used during a given manufacturing process (e.g., to perform unit operations and / or collect measurements); (ii) a process design display panel containing a graphical rendering of one or more unit operations performed during the manufacturing process (e.g., as link tiles); (iii) a data entry and calculation panel containing a graphical rendering of multiple fields (e.g., text entry boxes) for entry of raw data and corresponding calculations; and (iv) a material preparation and data calculation panel containing a graphical rendering of multiple input fields and / or output calculations corresponding to material preparation inputs and calculations.

[0070] In certain embodiments, the unit operation includes causing a graphical rendering of a real-time data display panel and dynamically updating the real-time data display panel according to variations in values ​​of parameters input to and / or collected from one or more interconnected devices.

[0071] In certain embodiments, step (b) includes causing, by the processor, a graphical rendering of a process design panel, the process design panel including one or more selectable icons (e.g., link tiles), each representing a particular unit operation in the manufacturing process; receiving, by the processor, a user selection of a particular unit operation for data review and / or entry via user interaction with a corresponding one of the one or more selectable icons in the process design panel; and updating, by the processor, one or more of the real-time data display panel, the data entry and calculation panel, and the material preparation and data calculation panel to reflect data associated with (e.g., collected during and / or entered into) the particular unit operation (e.g., updating includes identifying a set of data associated with the particular unit operation (e.g., and the particular manufacturing process) in one or more databases (e.g., knowledge bases) based on a stored ontology that links unit operations, manufacturing processes, input parameters, and collected data in a relational manner (e.g., in a hierarchical manner, e.g., via a knowledge graph)).

[0072] In another aspect, the present invention is directed to a system for facilitating user management of a manufacturing process (e.g., an experimental (e.g., lab or pilot scale) process developed for / in the design of a manufacturing process; e.g., a commercial scale production process) for producing a pharmaceutical product (e.g., a cell therapy product, e.g., a biological agent) via an interactive manufacturing management graphical user interface (GUI), the system including a processor of a computing device; and memory having stored thereon instructions that, when executed by the processor, cause the processor to: (a) generate information corresponding to a plurality of unit operations in a particular manufacturing process, the operations performed in the multi-unit operation manufacturing process, and / or the information collected about the plurality of unit operations in the particular manufacturing process; (b) receiving and / or accessing manufacturing process data representing the manufacturing process (e.g., information collected before, during, and / or after one or more of the plurality of unit operations is performed); and (b) causing the rendering of a graph-based visualization of the particular manufacturing process via the manufacturing management GUI, wherein the graph-based visualization includes a plurality of interactive nodes (e.g., graphical icons such as (e.g., color-coded) interconnected circular icons), each of which represents an individual data point corresponding to a particular action performed at one of the plurality of unit operations and / or a particular set of information collected for a particular one of the plurality of unit operations (e.g., information collected before, during, and / or after the particular unit operation).

[0073] In another aspect, the invention is directed to a system for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, the system including a processor of a computing device; and a memory having stored thereon instructions that, when executed by the processor, cause the processor to: (a) receive and / or access manufacturing process data corresponding to a particular manufacturing process and representing operations performed in a multiple unit operation manufacturing process (e.g., unit operations in the particular manufacturing process) and / or information collected during the particular manufacturing process; and (b) generate a graphical rendering of one or more interactive panels representing the operations and / or information collected during the manufacturing process, the one or more interactive panels including one of: This includes (e.g., up to all of): (i) a real-time data display panel containing a graphical rendering of data obtained from and / or input into one or more connected devices used during a particular manufacturing process (e.g., to perform unit operations and / or collect measurements); (ii) a process design display panel containing a graphical rendering (e.g., as link tiles) of one or more unit operations performed during the manufacturing process; (iii) a data entry and calculation panel containing a graphical rendering of multiple fields (e.g., text entry boxes) for input of raw data and corresponding calculations; and (iv) a material preparation and data calculation panel containing a graphical rendering of multiple input fields and / or output calculations corresponding to material preparation input and calculations.

[0074] Features of embodiments described with respect to one aspect of the invention may be applied with respect to another aspect of the invention.

[0075] The foregoing and other objects, aspects, features and advantages of the present invention will become more apparent and better understood by reference to the following detailed description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0076] [Figure 1] FIG. 1 is a block flow diagram illustrating a CMC database management system according to an example embodiment. [Figure 2] 1A-1C illustrate three different backend infrastructure schemas for view-based data integration of a CMC portal, according to an example embodiment. [Figure 3] FIG. 1 is a block flow diagram illustrating a federating server for CMC data reconciliation, according to an example embodiment. [Figure 4A] 1 is a view of a first image of a display screen or portion thereof including an interactive graphical user interface (GUI), according to an embodiment. [Figure 4B] 10 is a view of a second image of a display screen or portion thereof including an interactive graphical user interface (GUI), according to an embodiment. [Figure 5A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 5B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 6A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 6B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 7A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 7B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 7C] 1 is another view of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 8A]1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 8B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 8C] 10 is a view of a third image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 9] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 10A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 10B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 10C] 10 is a view of a third image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 11] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 12] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 13A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 13B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 13C] 10 is a view of a third image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 13D] 10 is a view of a fourth image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 14A]1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 14B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 14C] 10 is a view of a third image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15C] 10 is a view of a third image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15D] 10 is a view of a fourth image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15E] 10 is a view of a fifth image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 15F] 10 is a view of a sixth image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 16] 10 is a view of a seventh image of a display screen or portion thereof including an interactive GUI, according to an embodiment. [Figure 17] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 18] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 19] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 20A]1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 20B] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 20C] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 21A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 21B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 21C] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 21D] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22C] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22D] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22E] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 22F] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 23A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 23B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24B] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24C] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24D] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24E] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24F] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24G] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24H] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24I] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 24J] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 25A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 25B] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 25C] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 25D] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 25E] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 26A] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 26B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 26C] 1 is a view of a first image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 26D] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27C] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27D] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27E]10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 27F] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28B] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28C] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28D] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28E] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 28F] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 29A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 29B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 29C] 10 is a view of an image of a display screen or portion thereof including an interactive GUI showing a new design, according to another embodiment. [Figure 30] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 31] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 32]1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 33A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 33B] 10 is a view of a second image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34A] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34B] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34C] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34D] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34E] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34F] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34G] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34H] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34I] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 34J] 1 is a view of an image of a display screen or portion thereof including an interactive GUI, according to another embodiment. [Figure 35]FIG. 1 is a schematic diagram illustrating steps and data sampling performed across multiple manufacturing processes, according to an exemplary embodiment. [Figure 36] FIG. 1 is a block diagram illustrating various unit operations associated with multiple manufacturing processes according to an illustrative embodiment. [Figure 37] FIG. 1 illustrates a block flow diagram of an exemplary process for providing a graph-based visualization of a manufacturing process in accordance with an exemplary embodiment. [Figure 38A] 1 is a screenshot of an exemplary GUI showing a process graph representing a pharmaceutical product manufacturing process, according to an exemplary embodiment. [Figure 38B] 1 is a screenshot of an exemplary GUI showing a process graph representing a pharmaceutical product manufacturing process with interactive popups corresponding to nodes, according to an exemplary embodiment. [Figure 38C] 10 is a screenshot of an exemplary GUI illustrating visualization of data health and selection matrices, according to an exemplary embodiment. [Figure 38D] 10 is a screenshot of an exemplary GUI illustrating visualization of data health and selection matrices, according to an exemplary embodiment. [Figure 38E] 1 is an annotated screenshot of an exemplary GUI illustrating the relationship between process nodes and graphical representations of data points, according to an exemplary embodiment. [Figure 38F] 1 is an annotated screenshot of an exemplary GUI illustrating the relationship between process nodes and graphical representations of data points, according to an exemplary embodiment. [Figure 38G] 1 is a screenshot of an exemplary interactive data analysis view, according to an exemplary embodiment. [Figure 38H] 1 is a screenshot of two graphs generated via a graph-based visualization tool described herein, according to an example embodiment. [Figure 38I]10 is a screenshot illustrating multiple process graphs aligned and overlaid for comparison, according to an example embodiment; [Figure 39A] FIG. 1 is a block flow diagram illustrating a process for providing an experimental process design and data collection GUI in accordance with an illustrative embodiment. [Figure 39B] 1 is a screenshot of an exemplary experimental process design and data collection GUI, according to an exemplary embodiment. [Figure 39C] 1 is a screenshot of an exemplary experimental process design and data collection GUI, according to an exemplary embodiment. [Figure 39D] 1 is a screenshot of an exemplary experimental process design and data collection GUI, according to an exemplary embodiment. [Figure 40] FIG. 1 is a schematic diagram illustrating an implementation of a network environment for use in providing the systems, methods, and architectures described herein, according to an example embodiment. [Figure 41] FIG. 1 is a schematic diagram illustrating an example computing device that can be used to implement the techniques described herein, according to an example embodiment.

[0077] The features and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, identical reference numbers generally indicate identical, functionally similar, and / or structurally similar elements. DETAILED DESCRIPTION OF THE INVENTION

[0078] Specific Definitions About or Approximately: The terms "about" or "approximately," when used herein with reference to a value, refer to a value similar to the referenced value. Generally, a person of ordinary skill in the art familiar with the context will understand the relevant degree of variation that "about" or "approximately" encompasses in that context. For example, in some embodiments, the term "about" or "approximately" can encompass a range of values ​​that are within 25%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less of the referenced value.

[0079] Manufacturing process: As used herein, the term "manufacturing process" refers to any process involved in the design, preclinical testing, clinical testing, scale-up of manufacturing, and execution of commercial-scale production to manufacture a pharmaceutical product. For example, as used herein, a manufacturing process may include laboratory experiments performed to evaluate a candidate pharmaceutical product, including, for example, the synthesis of compounds and / or biologics, and in vitro assays such as animal studies and / or in vivo testing. In certain embodiments, a manufacturing process may refer to clinical tests or clinical trials (e.g., in human subjects). In certain embodiments, a manufacturing process may include process design experiments used to scale up production, e.g., from small-scale laboratory experiments or pilot-level production to commercial-scale production, or used to optimize a manufacturing process. In certain embodiments, a manufacturing process is a commercial-scale process used to produce a pharmaceutical product for commercial use and / or sale. Pharmaceutical products may include small molecules, biologics, cell therapies, etc., and may include one or more active agents formulated with a compatible carrier (e.g., liquid or solid filler), solvent, diluent, or excipient. Pharmaceutical products can take a variety of forms, depending, for example, on the desired mode of administration. For example, pharmaceutical products can be specifically formulated for administration in solid or liquid form, including: oral administration, e.g., drenches (aqueous or non-aqueous solutions or suspensions), tablets, e.g., buccal, sublingual, and those targeted for systemic absorption, boluses, powders, granules, pastes for application to the tongue; parenteral administration, e.g., by subcutaneous, intramuscular, intravenous, or epidural injection, e.g., as a sterile solution or suspension, or sustained-release formulation; topical application, e.g., as a cream, ointment, or sustained-release patch, or as a spray applied to the skin, lungs, or oral cavity; vaginal or rectal administration, e.g., as a pessary, cream, or foam; sublingual; intraocular; transdermal; or suitable for nasal, pulmonary, and other mucosal surfaces.

[0080] Unit operation: As used herein, a unit operation refers to a discrete step or action performed in a manufacturing process. Unit operations can include operations involved in producing a pharmaceutical product or one or more components thereof, as well as assays and experimental tests used, for example, to evaluate the properties of the produced composition. For example, unit operations can include steps for obtaining various starting materials, material preparation steps, steps such as thawing, selection, washing, or volume reduction steps, expansion steps, filling steps, formulation steps, freezing steps, transduction steps, harvesting, activation, various chemical synthesis steps, and analytical assays, for example, various in vitro assays (e.g., fluorescence-based assays, e.g., ELISA assays, flow cytometry, cell viability assays, cytotoxicity assays, etc.) and their substeps, and / or in vivo tests such as animal model experiments.

[0081] Detailed Description The systems, architectures, devices, methods, and processes of the claimed inventions are intended to encompass variations and adaptations developed using information from the embodiments described herein. Adaptations and / or modifications of the systems, architectures, devices, methods, and processes described herein may be made as contemplated by this description.

[0082] Throughout this description, where articles, devices, systems and architectures are described as having, including, or comprising particular components, or processes and methods are described as having, including, or comprising particular steps, it is contemplated that there are additionally articles, devices, systems and architectures of the invention that consist essentially of or consist of the recited components, and processes and methods of the invention that consist essentially of or consist of the recited process steps.

[0083] It should be understood that the order of steps or order for performing certain actions is immaterial so long as the invention remains operable. Moreover, two or more steps or actions may be conducted simultaneously.

[0084] The citation of any publication herein, for example, in the Background section, is not an admission that the publication is prior art with respect to any of the claims presented herein. The Background section is provided for clarity and is not intended as a description of prior art with respect to any claim.

[0085] Documents are incorporated herein by reference as noted. In the event of a discrepancy in the meaning of a particular term, the meaning provided in the Definitions section above shall control.

[0086] Headers are provided for the convenience of the reader, and the presence and / or placement of headers is not intended to limit the scope of the subject matter described herein.

[0087] A. CMC Database Management System 1 is a block flow diagram illustrating a CMC database management system for pharmaceutical manufacturing, according to an exemplary embodiment. The system includes a process control module, a process design and execution module, a process modeling module, a digital monitoring room and business insights module, and a knowledge base module. The process control module contains control software that enables real-time decisions and predictions / insights of the manufacturing process (lab, pilot, or commercial scale). Data is passed (bidirectionally) between the process control module and the knowledge base.

[0088] The process design and execution module of FIG. 1 includes a process designer, a process director, and a data collection sub-module. The data collection module includes functionality providing for the development of custom modules and ontology-guided web components. The process designer enables interactive, drag-and-drop, GUI widget-enabled combinations of unit operations and variable settings for the design of manufacturing processes. Data is passed (bidirectionally) between the process design and execution module and a knowledge base. As described in further detail herein, in certain embodiments, among other things, the process designer presents users with an intuitive graphical approach for designing manufacturing processes, which can be represented as graphs and stored, for example, in a knowledge base. In this manner, users can create complex and detailed process graph data structures through an intuitive graphical programming interface without coding expertise.

[0089] The process modeling module provides data for hybrid, statistical, and optimization modeling of pharmaceutical product manufacturing processes and includes data preparation, model creation, and model validation submodules. The process modeling module can be integrated to enable connection with a machine learning (ML) module that implements one or more specific machine learning algorithms, such as artificial neural networks (ANNs), random forests, decision trees, support vector machines, etc., to determine one or more output values ​​for a given input. The ML algorithms may be trained as new data is collected and / or may be locked to one or more specific times. Data is passed (bidirectionally) between the process modeling module and the knowledge base.

[0090] The Digital Monitoring Room and Business Insights module includes a data monitoring dashboard (e.g., a proprietary CMC development portal), a real-time analytics sub-module, an insights module, and an enterprise module. The data monitoring dashboard may include, for example, a "story"-based visual layout / text presentation combined with real-time updated structured (tagged) data with user interactive features, as described in more detail herein. The insights module may include analytical tools for creating product and / or manufacturing process insights, including interactive features such as tiling, expanding graphs, process dashboards, and patient dashboard layouts, as described in more detail herein. Data is typically passed from a knowledge base to the Digital Monitoring Room and Insights module.

[0091] The knowledge base module provides scalable computation and storage of data collected from and transmitted to various other modules. Among other things, it provides a taxonomy, structure, and hierarchy for handling data granularity, ontologies, and data harmonization. The process definition provides tags for collected data, for example, according to the devices, materials, and processes used. In certain embodiments, the provided taxonomies include classifications and / or categorizations of data, thereby providing a structured approach. In certain embodiments, the provided systems utilize hierarchies to help manage data at different levels of detail (data granularity). In certain embodiments, the provided systems and methods include ontologies (e.g., stored ontologies) that describe the nature and interrelationships of the data. This helps harmonize or standardize data from various sources for consistency and compatibility. Additionally, the process definitions in this system include tags. These tags are applied to data based on specific criteria, such as the devices used to collect the data, the materials involved, and the processes used. This tagging facilitates data identification, sorting, and use.

[0092] In particular embodiments, the system may utilize a view-based data integration system (VDIS) to generate responses to user queries, where the VDIS accesses multiple data sources having disparate data formats via federated servers, resolves one or more inconsistencies from the combined data, and generates integrated results in response to the user's query. In the context of using an ontology to reconcile multiple data sources for federated queries with a GraphQL endpoint, the provided process may include one or more of the following:

[0093] Ontology-Based Harmonization: In certain embodiments, an ontology provides a structured framework for defining and representing knowledge. In the context of multiple data sources, an ontology is used to harmonize and / or integrate the data. This means moving to a common understanding or format even when different data sources use different terminology or structures. This harmonization function facilitates the integration of data from diverse sources by ensuring that similar concepts from different databases are recognized as such (e.g., related).

[0094] Multiple Data Sources: In certain embodiments, the systems and methods of the present disclosure include multiple data sources, i.e., various databases or information repositories in which data is stored. These sources may have different structures, formats, or models for representing the data.

[0095] Federated Queries: In a federated system, queries can be created across multiple autonomous databases. Among other things, the system allows users to create a single query that accesses multiple databases without having to interact with each database individually. This is especially useful in environments that do not centralize data.

[0096] GraphQL Endpoints: GraphQL is a query language for APIs and a runtime for executing those queries, using a type system that, for example, a user, a specific group of users, or a company, defines for their data. In this context, GraphQL endpoints are the interfaces through which queries are executed against a federated system. They allow users to request exactly what they need and nothing more, making them efficient and precise. GraphQL also allows for complex queries involving multiple types of data, which is essential in a federated system where data comes from diverse sources.

[0097] In certain implementations, these systems enable efficient and effective data integration by using ontologies to standardize and harmonize data from multiple sources. Users can access this integrated data through federated queries using GraphQL endpoints, which provide a flexible and powerful way to search for exactly what they need from the combined data sources.

[0098] In certain embodiments, data sources accessed by the database management system are at least partially harmonized at the time of data collection by restricting data entry within a number of predefined fields and / or values. In this way, for example, data collected from equipment by different operators at different times benefits from uniform labeling of process input variables provided by the operators, resulting in less unresolvable data. In certain embodiments, the provided system utilizes ontologies for standardization. An ontology refers to a specific set of rules and structures that define how data is organized and interpreted. In certain embodiments, it provides a common framework or language for describing and classifying data. The ontology approach can be achieved by creating and defining ontologies that are stored in a knowledge database. For example, a user, group of users, organization, etc., can predefine materials, devices, step names / types, and even specific types of data / variables (e.g., DMSO exposure start time) in the knowledge base and create links between metadata (e.g., specific components and their manufacturers (e.g., PL07-2G bags are manufactured by OriGen Biomedial)). Thus, in certain embodiments, when a particular user (e.g., operator) is designing an experiment, information from the knowledge base is fed into the process design such that the operator can be restricted to using only pre-registered materials, devices, etc. In this manner, the systems and methods provided, in certain embodiments, allow for the implementation of a common ontology around unit operations, materials, and their associated dates.For example, rather than allowing a user to enter, for example, the names of components or materials used (e.g., a particular bag type) without restriction, they may be restricted to predefined fields (e.g., an operator may only be able to select and use a "PL07-2G" bag), thereby preventing individual and / or multiple users from entering different data in an inconsistent manner to represent the same parameter, material, ingredient, etc. (e.g., without this feature, an operator might write PL7, or PL-7, or PL07, which the operator would understand as the same, but which the computer would understand as all different materials or require a great deal of coding to establish as similar). Similarly, an operator could indicate a manufacturer as OriGen, or OriGen Bio, or OriGen Biomedical, which would cause the same problem.

[0099] In certain embodiments, the systems and methods include harmonization at the data collection point, where the harmonization process begins as soon as data is collected. In certain embodiments, this is achieved by utilizing approaches for restricting data entry to a predefined set of fields and / or values, as described herein. In this way, collected data is immediately structured and standardized according to an ontology, reducing variability and inconsistency. The disclosed CMC manufacturing systems and methods can provide predetermined fields and / or values, specific categories, or parameters established by the ontology. By restricting data entry to predefined fields and values, the approaches described herein can ensure that collected data is uniform and conforms to a standardized format. This facilitates subsequent stages of data processing and analysis, among other things, simplifying and streamlining these processes.

[0100] Uniform labeling by different operators: In a real-world scenario, different operators may use equipment at different times. The use of a standardized ontology ensures that the data collected is consistent regardless of who operates the device or when it is used. This is because all operators must enter the data in the same way, using the same predetermined fields and values.

[0101] FIG. 2 illustrates three different backend infrastructure schemas for view-based data integration in a CMC portal, according to an example embodiment. These schemas are used, for example, to build a single source of truth for queried data and to resolve inconsistencies between data retrieved from multiple data sources. In one embodiment, the view-based data integration system (VDIS) includes a both-as-view (BAV) backend infrastructure, shown in the center, also known as a global and local as view (GLAV) backend infrastructure. In the BAV (also known as GLAV) infrastructure shown in FIG. B, for example, global and local schemas are connected via bidirectional (global-to-local and local-to-global) transformation paths, where RDB stands for relational database, RDF stands for Resource Description Framework, and XML stands for Extensible Markup Language. In another embodiment, the VDIS includes a global-as-view backend infrastructure, shown on the left of FIG. 2, where the global schema is connected to the local schema via a view definition (global-to-local). In another embodiment, the VDIS includes a local-as-view backend infrastructure, shown on the right of FIG. 2. Here, local schemas are connected to global schemas via view definitions (local to global). In any of these examples, the VDIS may include a mediator that translates queries into multiple source-specific queries and sends the source-specific queries to one or more wrappers for execution. The back-end infrastructure queries multiple sources containing heterogeneous structured data to be integrated into a unified view. In certain embodiments, the system implements a graph-based real-time digitization and contextualization engine. In certain embodiments, one or more of the multiple data sources are reconciled at the time of data collection by restricting data input within multiple predetermined fields and / or values.

[0102] 3 is a block flow diagram illustrating a federating server for CMC data harmonization, according to an exemplary embodiment. In this example, a data management system includes a federated server that receives both ontology-guided manufacturing data and ontology-guided clinical data (e.g., ontology-guided data harmonization as described herein). In certain embodiments, only manufacturing data is used, and in other embodiments, only clinical data is used. The federated server may include a database management system (e.g., VDIS) that receives queries and generates query responses using the integrated, harmonized data. In certain embodiments, the system includes an ontology harmonization process as shown. B. Graphical User Interface

[0103] Presented herein is a graphical user interface for use with the database management system described herein and / or its separate modules.

[0104] Described herein are embodiments of interactive graphical user interfaces (GUIs) that visually communicate to a user information regarding, among other things, (i) the creation and / or modification and / or analysis of unit operations in a manufacturing process, such as a cell and gene therapy manufacturing process, and the data generated therefrom, (ii) the combination of live data from a database with textual information, and (iii) the interactive analysis of data, e.g., a patient data visualization system, and a system for data analysis related to a manufacturing process. For example, in certain embodiments, the GUIs of the present disclosure provide users with multiple levels of detail about the experimental and manufacturing processes, which may be visually presented to the user in a variety of formats, including certain combinations of charts and / or dynamic elements that the user can navigate in an interactive manner.

[0105] i. Process Director For example, FIGS. 4A-12 illustrate GUI views including one or more linked tiles. In certain embodiments, each tile represents a step in a particular experimental and / or manufacturing process. Thus, GUI views such as those illustrated in FIGS. 4A-12 can visually communicate to a user the various steps in a particular process and the interrelationships (e.g., input and / or output relationships) between the steps. In certain embodiments, as illustrated in FIGS. 4A and 4B, for example, one or more tiles are dynamic, such that upon user interaction with a particular tile (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) appears that can convey additional information to the user regarding the process step represented by the particular tile. For example, FIG. 4A illustrates a first image of a GUI view presenting multiple linked tiles, and FIG. 4B illustrates a second image of the GUI view, in which a pop-up window appears in association with a particular tile after a user's interaction with the particular tile. Additional embodiments are illustrated in FIGS. 5A-6B.

[0106] In certain embodiments, the pop-up window can display an expandable sub-display, as shown, for example, in Figures 7A and 7B. In certain embodiments, the pop-up window can be scrollable, allowing a user to scroll through vertically arranged information about a particular step, such as transitioning between the series of three images shown in Figures 8A-8C and 10A-C, for example, transitioning between the series of three images shown in Figures 10A-C.

[0107] 7C, 9, 11, and 12 show various embodiments of tiled displays that may additionally or alternatively be used.

[0108] Process diagrams generated in accordance with the CMC manufacturing techniques described herein can provide a convenient and informative way of representing the sequence and / or connections between different stages of an experimental and / or production process. In certain embodiments, each linked tile corresponds to a node representing a particular unit operation in a particular manufacturing process. Lines linking one tile to another convey the flow of material and / or data from one unit operation to another. Conveying connections between various unit operations in this manner can provide a wealth of context and information about how the nodes (unit operations) relate to each other, which in certain embodiments can be used, for example, to direct the flow and / or use of data for automation of a process, its portions, associated data management tasks, etc. In certain embodiments, the relationships between nodes can be used in modeling techniques, for example, as input features to a neural network model.

[0109] For example, lines, such as the links between tiles shown as lines in Figures 4A-12, can provide context about process operations, such as when cells are divided into one or more cell groups (e.g., dividing cells into transduced treatment and process control groups) and / or when multiple cell groups are combined (e.g., adding a particular active cell). Enabling users to create and / or visualize connections between unit operations in this manner enhances the process views described herein's ability to present detailed information and overcomes other approaches, such as accordion- and list-style displays of nodes, where this connection context information would be lost and / or obscured.

[0110] ii. Process Designer In certain embodiments, GUI views of the present disclosure visually convey information related to various steps of a process to a user in a manner that enables the user to design a new process. For example, FIGS. 13A-D illustrate GUI views including tiles representing particular process steps along with associated pop-up windows displaying one or more editable fields of parameters that the user can select and / or edit. In this manner, GUI views such as those illustrated in FIGS. 13A-D facilitate user creation and design of new processes, e.g., via a graphical editor, by visually conveying information related to new process steps in an intuitive and accessible manner. FIGS. 14A-C illustrate another series of images of GUI views for user design of a new process, as used in certain embodiments. FIGS. 15A-F and 16 illustrate another series of images of GUI views for user design and / or analysis of a new process (e.g., as shown in FIG. 16), as used in certain embodiments. FIGS. 17-19 illustrate images illustrating various tile designs and layouts, as used in certain embodiments.

[0111] In certain embodiments, when a user creates the process diagrams shown in Figures 13A-19, creating tiles, entering data and information, drawing connecting lines, and otherwise interacting with the GUI, an underlying graph data structure (e.g., nodes representing the unit operations and material and data flows of a manufacturing process and the links (e.g., edges) between them) is created, enabling the user to generate complex data structures in a graphical programming / "no code" fashion. The graph data structure created in this manner can then be provided (e.g., as input) to various other modules for, for example, comparison between other processes (e.g., as described in Section C below with respect to Figures 38A-F), data analysis and generation of interactive views (e.g., any of the analytical views shown in Figures 20A-28F and / or described in Section B.iii, additionally or alternatively, in Section C below and Figures 38A-F below), performance of process control and / or optimization tasks (e.g., as described in Sections B.iv-B.vi and D and in connection with any of the views shown in Figures 29A-31J and 39A-D), and modeling (e.g., via machine learning techniques).

[0112] iii. Data Display and Interactive Views In certain embodiments, the GUI views of the present disclosure visually display data associated with and / or generated by various experimental and / or manufacturing processes. Patient Tile

[0113] Data display views of the present disclosure may include views for visually presenting clinical trial data to a user, for example, as shown in FIGS. 20A-23D. For example, in certain embodiments, a clinical trial data display view of the present disclosure may include a chart including patient tiles, each representing a particular patient participating in a clinical trial. As shown in FIGS. 20A-C, various embodiments of the patient tile chart may include tiles of different colors, shading, line styles, etc. to visually convey data, such as a patient's clinical response. In certain embodiments, the patient tile / summary chart may be displayed in conjunction with text, for example, as part of an interactive report or story. In certain embodiments, the patient tile chart may be provided as part of an interactive dashboard, allowing a user to click or otherwise select a particular patient tile to view additional details about the particular patient, for example, via a pop-up shown in the image series of FIGS. 21A and B, 21C and D, and 23A and B. In certain embodiments, a patient tile view of the present disclosure may include a view displaying a patient tile including graphs showing variation (e.g., over time) of various biomarkers, as shown in FIGS. 22A-F. Biomarker graphs may be displayed, for example, as lines as shown in Figures 22A-D, in a cross-hatched style as shown in Figures 22E and F, or in other ways.

[0114] Cell Data View In certain embodiments, data display views of the present disclosure include a cell data view that tracks the variation of various metrics (e.g., performance metrics) for multiple cell lines over the course of a manufacturing and / or experimental process. The cell data view may be presented as an organized dashboard, such as those shown in FIGS. 24A-J. In certain embodiments, an interactive dashboard for viewing cell data displays data for one or more lots. In certain embodiments, data for multiple lots may be displayed and visually presented to a user, as shown, for example, in FIGS. 24A-C. In certain embodiments, a particular lot may be displayed by itself, as shown, for example, in FIG. 24D.

[0115] Swimmer Chart View In certain embodiments, data display views of the present disclosure include views that present a user with a visual dashboard including a swimmer chart that visually communicates a patient's response to treatment over time, as shown, for example, in Figures 25A-C. In certain embodiments, swimmer chart views according to the present disclosure may include interactive and animated elements that allow a user to select a data point in the chart to reveal additional information, as shown, for example, in Figures 25B and C. For example, in certain embodiments, user selection of a data point on the chart may trigger a pop-up effect, resulting in Figures 25B and C appearing sequentially.

[0116] Emission metrics and characterization views In certain embodiments, a data display view of the present disclosure provides a visual display of release metrics and characterization of one or more drugs. In certain embodiments, product release data may be displayed in charts in conjunction with text, e.g., as an interactive and / or dynamic report or story, as shown, for example, in Figures 26A and B and 26C and D. In certain embodiments, the release metrics view may be presented as a visual dashboard (e.g., an interactive dashboard), as shown, for example, in Figures 27A-F.

[0117] Star Plot In certain embodiments, process data and / or experimental data may be displayed in a circular format to illustrate the cyclical nature of process / product development, for example, as shown in FIGS. 28A-E.

[0118] Process Data View In certain embodiments, data associated with various processing steps may be displayed in interactive stories and / or charts, for example, as shown in FIG. 28F.

[0119] iv. Process Control and Monitoring View In certain embodiments, GUI views of the present disclosure include graphical displays that visually communicate to a user the progress and / or performance of various manufacturing and / or experimental processes, as shown, for example, in Figures 29A-31. In certain embodiments, process monitoring views include interactive features whereby additional visual elements appear in a dynamic manner. For example, Figures 29A and B show first and second images in a dynamic display whereby visual elements appear to a user as the user selects a particular step in the process, for example, via the view shown in the first image.

[0120] v. Report Customization and IND Reports In certain embodiments, GUI views of the present disclosure include graphical displays used in connection with user creation and / or customization of report generation. For example, FIG. 32 illustrates a visual dashboard that allows a user to customize or configure reporting functions by visually displaying data elements and reporting functions for user selection. In certain embodiments, diagrams displaying data charts are formatted to display specific variables, data, etc., according to user interaction and selections with a configuration dashboard such as that shown in FIG. 32. For example, the charts shown in FIGS. 33A and B are examples of charts configured according to selections made by a user through interaction with a configuration dashboard according to the embodiment shown in FIG. 32. In certain embodiments, the designs shown in FIGS. 33A and B include dynamic diagrams, whereby visual elements are displayed in a dynamic manner upon user interaction with one or more data points.

[0121] vi. Device Toolkit In certain embodiments, the GUI views of the present disclosure visually display lists and information about various devices that may be used in an experiment and / or manufacturing process. Figures 34A-J show various embodiments and comparative views of device views.

[0122] C. Graph-based visualization and interactive data view generation for pharmaceutical manufacturing process data harmonization In certain embodiments, the CMC management techniques of the present disclosure provide graph-based visualization tools that allow a user to analyze data associated with one or more experimental and / or manufacturing processes used to produce a pharmaceutical product and / or variations thereof. In particular, the graph-based visualization and data analysis tools described herein can be used to automatically and / or semi-automatically generate (e.g., in conjunction with user review and / or input) visualizations that facilitate examination of experimental and / or manufacturing processes, as well as to reconcile data generated across multiple processes and / or process runs.

[0123] For example, an interactive graph-based CMC management tool may include, among other elements, one or more of the following elements, which may be provided (e.g., rendered) individually or collectively via one or more GUIs or their windows, sub-windows, panels, etc.:

[0124] Process Graphs. In certain embodiments, graph-based visualization tools of the present disclosure include generating and / or rendering process graphs representing experimental and / or manufacturing processes for the production of pharmaceutical products, including biologics such as cell-based therapies and biologics. A process graph may include multiple nodes, each representing a data point corresponding to a unit operation in a particular experimental and / or manufacturing process, where information is collected and / or an action is performed. Various approaches for capturing and / or representing these data points, and how a user may interact with them, are described in further detail herein.

[0125] Data Health and Selection Tool. In certain embodiments, the graph-based visualization tool of the present disclosure includes a data health and selection tool capable of assessing the health or integrity of data collected at various steps of an experiment and / or manufacturing process. As described in further detail herein, the data health and selection tool can use one or more criteria used to assess data health, such as completeness, accuracy, consistency, etc. Additionally or alternatively, a user can interact with the data conveyed by the process graph to select a set of data points for more focused analysis, e.g., thereby affecting (e.g., updating, modifying) the visualization of the process graph and / or resulting in the generation of additional GUIs, such as the various data displays and interactive views described herein (e.g., in Section B above).

[0126] Comparison and Alignment of Multiple Processes. In certain embodiments, graph-based visualization tools of the present disclosure provide for comparison and / or alignment of data from multiple experiments and / or manufacturing processes, e.g., in an automated and / or semi-automated manner (e.g., in conjunction with user interaction, review and selection actions, etc.). Among other things, the approaches described herein can (e.g., automatically) overlay multiple process graphs, structurally compare them, and align them based on data points. For example, the process comparison and alignment tool can (e.g., automatically) identify and process inconsistencies, missing data, or anomalies, which can be used to generate a harmonized data set for further analysis, such as mathematical modeling.

[0127] Thus, among other things, the disclosed graph-based visualization tools address the challenges presented by misaligned data across multiple experiments and / or manufacturing processes and / or within a single process that may be run under various conditions. Achieving automatic reconciliation of such data is a significant challenge that, if not addressed, can hinder efficient and accurate analysis, which in turn can dramatically impact a user's and / or organization's ability to optimize manufacturing processes and / or maintain quality and / or develop new ones. Among other things, the disclosed systems and methods address the challenge of analyzing data from experiments using various sampling plans. As described in further detail herein, CMC manufacturing techniques (e.g., graph-based visualization) can assist in aligning sampling points to maximize overlap for effective comparison and / or, in certain embodiments, identify overlapping points in existing data for efficient real-time analysis.

[0128] For example, Figure 35 is a schematic diagram showing a process flow diagram of the manufacturing procedure, showing different stages labeled by day, such as day 0, day 6, day 9, day 14, and day 24. As shown in the diagram, each stage involves various operations (e.g., thawing, washing, NK selection, transduction, etc.).

[0129] Dashed lines in the diagram separate days and indicate the temporal progression of the depicted processes, and vertical arrows highlight specific data sampling points (labeled "Sampling AD"). As is evident from the diagram, data sampling is performed at different times by different processes. This misalignment between processes can be seen, for example, by the uneven placement of sampling points across different stages or process flows. In an ideal, aligned set of processes, these sampling points would occur at corresponding stages across each individual process flow.

[0130] In certain cases, researchers can use diagrams such as the one shown in Figure 366 in process engineering to map and compare different process flows. In the context of manufacturing processes, these differences may represent experimental variations or optimizations tailored to specific goals. For example, the schematic diagram shown in Figure 36 illustrates a complex set of processes, each containing multiple steps. Each block in the diagram represents a process step, which is labeled with an identifier.

[0131] A researcher or engineer analyzing a schematic diagram such as that shown in FIG. 36B may aim to accomplish any of the following: (i) identify which steps are critical control points where conditions must be tightly controlled; (ii) understand the flow of materials and / or information through a system; (iii) compare the efficiency or yield of different processes; and / or (iv) ensure compliance with regulatory standards by maintaining consistent process conditions. Static versions of schematic diagrams such as those shown in FIG. 36B may, for example, have been created by previous techniques that, among other things, do not convey information about actual data collection, require careful consideration, and may rely on users to manually identify and analyze differences between processes and their impact on performance and results. In contrast, the CMC manufacturing platform of the present disclosure integrates the ability to collect actual data and link collections of actual data with diagrams. Furthermore, while not all data is directly visible at this level, providing dynamic nodes that are clickable / expandable and customized for each node type technology of the present disclosure allows users to simultaneously inspect and analyze collected and / or input data. In this manner, the systems and methods described herein facilitate the automatic identification and analysis of differences between processes.

[0132] In certain embodiments, structural differences between different processes indicate variations in conditions (e.g., temperature, duration, chemical concentrations) and the order and / or presence of certain steps. While the basic steps or phases in a unit operation, i.e., a process, may be generally similar in other processes, certain conditions and / or order can significantly impact the outcome or the nature of the product or result. Thus, visual representation tools can be very useful in process optimization, problem-solving, and ensuring that a process meets desired specifications. For example, changing a unit operation and / or the device performing a particular parameter value within a unit operation (e.g., spin speed, total volume, duration, etc.) can significantly impact the quality, recovery, efficiency, etc. of that unit operation, which in turn can affect product characteristics such as biology / potency, as well as additionally or alternatively, factors such as manufacturing cost, number of doses produced per manufacturing run, etc. Thus, despite the overall similarity between diagrams such as those shown in Figure 36B, input into the diagram from an operator during testing can have a significant impact. Thus, among other things, the CMC systems and methods described herein, and their use of a common ontology, greatly facilitate automating and identifying commonalities and / or differences between tests and performing analysis, e.g., determining whether device or parameter changes have significant impact.

[0133] In particular, as described herein, the graph-based visualization tools of the present disclosure provide users with techniques for visually representing one or more manufacturing processes through a graph-based approach that easily communicates and automatically highlights differences in conditions and unit operations and their precise nature. The graph-based tools described herein can be used to provide information about data collection and automatically highlight misaligned data points. This approach facilitates the identification and correction of data alignment issues, thereby streamlining data analysis for research and process development conducted in the creation and manufacturing of pharmaceutical products, such as cell-based therapies and biologics.

[0134] i. Process graph with interactive nodes Referring to FIG. 37 , in certain embodiments, a graph-based visualization tool 3700 can access manufacturing process data from a database 3702 and use it to generate and / or render a graph-based visualization 3704 that includes a process graph 3712 representing the manufacturing process(es).

[0135] A screenshot of an exemplary graph-based visualization is shown in Figure 38A. As shown, a manufacturing process can be represented and displayed via a process graph. Each node in the process graph represents a data point corresponding to a unit operation in the particular manufacturing process that the node (i.e., the process graph) represents. A node can include information about the current data status and content (e.g., real-time) of the data point it represents. Within the graph-based visualization, nodes can be dynamic; for example, user interaction with a particular node (e.g., hovering, clicking, tapping, or long-pressing on a touchscreen) can result in the display of a tooltip indicating the current data status at the represented data point, including data collected at various stages of the manufacturing process. Process graphs can be rendered and used in experiment design and process execution to outline complex manufacturing experiments with a series of multi-day manufacturing procedures and visualize and track different stages of the experiment in real time.

[0136] When generated and / or rendered via the graph-based visualization techniques of this disclosure, they may include all or various subsets (e.g., combinations) of the following features:

[0137] Experimental Summary. In certain embodiments, the graph is displayed as an Experimental Summary, providing a high-level overview of the experiment, including the process steps and the (e.g., approximate) order in which they were performed, the days that particular process steps were performed, how the process steps relate to each other (e.g., the top half of FIG. 38A ), and an overview of the various conditions / arms evaluated during the experiment and how those conditions relate to each other (e.g., the bottom half of FIG. 38A ).

[0138] Timeline. In certain embodiments, a process graph may include a timeline representing multiple timepoints, such as days, during which a particular experiment or manufacturing process represented by the graph is performed. As shown in FIG. 38A, the timeline may be represented along a horizontal axis, using labeled circular icons to visually represent individual timepoints (number of days from day 1 to day 21). Other ways of visually representing the timeline may be used, such as along a vertical axis and / or using other formats of icons, other units (e.g., hours, weeks, etc.).

[0139] Process Unit Operations. In certain embodiments, a process graph can visually identify individual process unit operations performed during a manufacturing process. Individual process unit operations may be represented, for example, via a combination of text labels and icons or markings that convey the specific unit operations performed and, optionally, the times at which they are performed and / or their relationship (e.g., temporal) to other unit operations. For example, the graph-based visualization shown in FIG. 38A includes a series of text labels along the top row [of nodes], identifying various unit operations such as "Material Preparation," "Activation," "Transformation," and "Formulation." In FIG. 38A, the text labels also include numerical elements that identify the specific days on which each unit operation is performed, and the text labels are arranged sequentially from left to right along the horizontal axis to mark the series of operations performed over time. Dotted vertical lines extending from each text label provide a visual guide to the planned schedule of each unit operation and / or a time mapping of the manufacturing process.

[0140] Data Points (Nodes). As shown in Figure 38A, data points in the manufacturing process that are associated with and about which information (measurements and / or recorded observations) is collected are represented via nodes. Nodes may be rendered as icons, such as the filled circles shown in Figure 38A. In the diagram, each circle is a node and is positioned to visually align with a particular unit operation. That is, in the diagram, it identifies a data point associated with a particular unit operation by being placed on a dotted vertical line extending from a text label identifying that particular unit operation.

[0141] Dynamic Nodes and Tooltips. In certain embodiments, nodes are rendered in a dynamic manner, such that user interaction with a particular node, e.g., by hovering over and / or selecting the node, reveals a tooltip containing the current data status at that time, e.g., quantitative data or qualitative observations. Figure 38B shows an exemplary popup rendered following user interaction with a particular node.

[0142] Connectivity. In certain embodiments, a process graph can represent material and / or data dependencies or sequences from one unit operation to another through rendered connections between various nodes. For example, as shown in Figure 38A, node connectivity can be rendered as lines connecting the nodes across a timeline.

[0143] Data collection points: Specific points along a process where data is collected are marked. Key checkpoints for measurements required for quality control or process evaluation.

[0144] Arms. In certain embodiments, a process graph of the present disclosure can include and / or represent one or more (e.g., separate) arms, each representing a different experimental condition and / or variation of a baseline process. In FIG. 38A , the arms are rendered as various smaller graphs located below the timeline. Each line in the arms section represents a different arm / condition defined by the operator. Labels are provided to clarify the focus of these steps and / or to help distinguish and identify nodes as belonging to one condition, ensuring that corresponding data collected from the lab is placed in the correct node and avoiding mixing of data across conditions. In this case, the base process may be the steps that follow the standard or control process, while others are steps that introduce experimental modifications to the process and / or supplement the base process, e.g., making media, preparing materials.

[0145] Baseline Processes and Baseline Process Graphs. A baseline process may be a control and / or standard procedure and may be rendered as a baseline process graph. Text labels, color schemes, icon styles, positioning, etc. may be used to visually identify the baseline process as in graph-based visualizations. For example, in FIG. 38A, the baseline process is identified and displayed as a line of nodes directly below the timeline. In the process graph of FIG. 38A, the baseline process is likely the standard process against which other variations are compared.

[0146] Variations and Outputs / Endpoints. In certain embodiments, a graph-based visualization may include one or more auxiliary subgraphs, each corresponding to an experimental condition and / or a baseline version of a manufacturing process and representing variations thereof. For example, FIG. 38A shows auxiliary subgraphs representing variations labeled "Ver1.1," "Ver1.2," "Ver2.1," "Ver2.3," etc., with different dosages of "Condition 1," "Condition 2," and "Condition 3" representing different experimental groups or conditions. In this manner, a graph-based visualization tool can be used to communicate variations in materials used, process conditions, or specific unit operations performed. Additionally or alternatively, different process endpoints and / or outputs may also be represented (e.g., by an endpoint graph). For example, as shown in FIG. 38A, the set of nodes labeled "Out.1" and "Out.2" represent different endpoints and / or outputs of a process, such as different processing methods or storage methods for the final product. As described herein, in the exemplary subgraph shown in Figure 38A, the lines refer to experimental conditions or subsets of interrelated processes, such as preparing materials (e.g., media) that are subsequently fed to a process involving cells. As noted above, the Arms / Conditions section serves to orient the operator to the specific task being performed and descriptively identifies the various arms so that data collected in the lab is entered into the corresponding node and numbers / volumes, etc. are not mixed across conditions.

[0147] Thus, the process graphs of the present disclosure facilitate the visualization and management of complex manufacturing processes. Among other things, they enable researchers to track the progress of experiments, compare different conditions or variations side-by-side, and ensure systematic collection of data at designated points throughout the process. The ability to visualize the entire process in this way helps identify bottlenecks, ensure consistency, and facilitate data-driven decision-making.

[0148] ii. Data Health and Display Choices. In certain embodiments, the graph-based visualization tool may include a GUI that allows a user to view collected data points, assess their health, and select points to generate charts (e.g., interactive charts) that facilitate focused analysis of various aspects of the bioproduction process.

[0149] For example, in certain embodiments, a graph-based visualization may be generated and / or rendered 3704 to include a data health and integrity display 3722 that facilitates visualization and assessment of data health. The data health and integrity display may include and visually convey multiple data point indicators, each representing collected and / or input values ​​of data parameters and / or variables at a particular timepoint and / or unit operation during a particular manufacturing process.

[0150] Examples of visualizations including rendered data points are shown in Figures 38C and 38D. Figures 38C and 38D each show a streamlined process graph and, below it, a data health and selection matrix. The data health and selection matrix is ​​arranged in multiple rows and columns, with each vertical column corresponding to a particular day and / or unit operation in the streamlined process graph shown at the top of the display, along a timeline. Each horizontal row represents a different data parameter or variable that is monitored or controlled throughout the process. Exemplary data parameters and / or variables include, but are not limited to, viable cell count, volume, concentration, and other relevant metrics.

[0151] In the example screenshots shown in Figures 38C and 38D, data point indicators may be rendered as dots to indicate the presence or absence of data for a particular unit operation. For example, color coding may be used to distinguish between collected data, missing data, and planned but skipped data collection points. For example, in Figures 38C and 38D, black dots indicate collected data, blue dots identify selected data points for further analysis, and the absence of a dot indicates missing data. By visually communicating and distinguishing between data points in this manner, users can quickly assess data completeness throughout the manufacturing process and / or identify areas of concern in the data collection process. Data health and selection matrix displays such as those shown in Figures 38C and 38D can ensure data integrity and robustness in manufacturing processes by highlighting patterns in data availability or systematically missing data.

[0152] In certain embodiments, data health and integrity matrices such as those shown in Figures 38C and 38D are interactive, allowing a user to select specific data points (indicated by color changes) to be used to generate one or more additional graphs that can be displayed and interacted with via the data analysis GUI and used for more detailed and / or targeted analysis of specific unit operations and / or parameters controlled and / or measured during the manufacturing process.

[0153] 38E and 38F show the correspondence between various nodes and / or data points and the underlying values ​​of the measured parameters. By combining the process graph with the data health and selection matrix, the graph-based visualization tools of the present disclosure provide users with a comprehensive overview of the process and its associated data. Among other things, they support decision-making, process optimization, and detailed analysis by allowing the visualization of the entire manufacturing process and its data landscape in one integrated view.

[0154] Figure 38G shows a screenshot of an exemplary data analysis interface, referred to as a "cell journey" chart, that is generated following user selection of one or more data points as described herein. The cell journey analysis interface shown in Figure 38G provides a visualization that represents a step-by-step analysis of process metrics and can be used to provide insight into cell behavior, process efficiency, and / or quality control.

[0155] The data analysis interface of the present disclosure can include a header section that includes summary statistics and / or graphical representations of data corresponding to selected data points collected across multiple lots, i.e., batches and / or experimental groups corresponding to a particular manufacturing process. For example, the screenshot in Figure 38G includes a "Products" tab that lists the total number of different production batches or experimental groups ("99 Lots"), the different product lines or experiments (e.g., A1, A2, A3, B), and a list of various lots ("Lot ID by Day").

[0156] In certain embodiments, the data analysis interface can include interactive graphical widgets that allow users to customize and / or toggle between different styles and variables plotted in dynamic charts. For example, the exemplary interface shown in FIG. 38G includes several sections of graphical widgets, including a Variable Display Mode section with a toggle ("Single" / "Multiple") that allows users to view individual process metrics separately or multiple metrics simultaneously. The Group by Process Version section includes a toggle ("Yes" / "No") that allows users to choose whether to cluster data according to different process iterations or conditions. The In-Process Analysis section includes several selectable widgets through which users can interact to select various cellular metrics, such as percentages of B cells, monocytes, and NK cells, viability, etc., for inclusion in visualizations. Absolute count metrics, such as viable cells and total nucleated cells (TNC), are also available, along with the option to include / exclude red blood cells (RBCs). The calculated metrics section allows for the selection of specific calculated metrics (e.g., calculated automatically by the processor), such as total number of NK cells, based on the raw data.

[0157] The data analysis interface may also include one or more dynamic charts, such as the cell journey chart shown in Figure 38G. The particular chart shown in Figure 38G plots the values ​​of a selected metric across various process unit operations, from "post-thaw" to "post-harvest." Each line represents a lot or batch (indicated by "daily lot ID") and shows the progression of a particular metric through the process.

[0158] 21A-21J show various versions of the data analysis view that provide cell data and, in certain embodiments, illustrate the impact of different user selections and controls via the graphical widgets described herein. Figure 38H shows two graphs plotting metrics of cell count and cell viability across various unit operations on a particular day.

[0159] In certain embodiments, the dynamic charts are interactive, allowing users to select data points directly on the graph, facilitating complex process tracking, for example, as shown in Figures 21A and 21B. This interactivity means that users can visualize progress without requiring prior data harmonization or processing, which can be particularly useful when working with real-time monitoring or raw data.

[0160] Thus, the interactive "Cell Journey" shown in Figure 38G provides a visual representation of the cell journey across multiple lots, highlighting trends, deviations, and process consistency that are essential for process understanding, control, and optimization.

[0161] In certain embodiments, interactive data selection can be used to generate and display other data analysis interface styles, such as patient tile views, various other cellular data views, swimmers chart views, emission matrices, star plots, etc., as described herein and illustrated in Figures 17A-25F.

[0162] In particular, the data analysis view of the present invention provides deep understanding of manufacturing processes and outputs (e.g., cell processing data) and includes robust data selection and visualization tools to support process analysis and decision-making in the biotechnology or pharmaceutical manufacturing context.

[0163] iii. Comparison and alignment of multiple processes In certain embodiments, the graph-based visualization tools of the present disclosure include techniques for the automatic comparison and alignment of multiple manufacturing processes. Among other things, this functionality facilitates understanding the interactions between different manufacturing processes, or the same process under different conditions.

[0164] 37, in certain embodiments, a user may select one or more additional processes 3732 to be compared to the initially selected and rendered process. The graph-based visualization tool of the present disclosure may then render, align, and / or overlay additional process graphs 3734, each representing the additional selected manufacturing processes, for comparison.

[0165] Figure 38I shows an exemplary screenshot generated via the techniques described herein. The screenshot shows multiple (three) overlaid and aligned process graphs, each representing a similar series of unit operations over a timeline of several days. These multiple process graphs can represent different experimental runs and / or batches in a manufacturing process. The screenshot illustrates the results of applying the described techniques, displaying three overlaid and aligned process graphs. Each graph represents a series of unit operations over a timeline of several days. These graphs represent different experimental runs or batches in a manufacturing process, allowing for easy comparison and analysis of these separate activities over the same period of time. By comparing multiple graphs in this manner, a user can, among other things: (i) Identifying Patterns and Trends: In certain embodiments, overlaying graphs allows users to easily spot common trends or patterns across different data sets or time periods. (ii) Assessing Consistency and Variability: In certain embodiments, comparing graphs helps assess the consistency of a process or experiment and identify variability or anomalies. (iii) Benchmark Performance: In certain embodiments, graphs can be used to represent different batches or experimental runs, allowing users to compare them and determine which performed better for a particular metric. (iv) Understanding Relationships: In certain embodiments, seeing how different variables interact over time can help understand the relationships between them. (v) Informed Decisions: In certain embodiments, the clear comparisons facilitated via the tools described herein facilitate making decisions based on empirical data, such as improving a process or replicating a successful experiment.

[0166] In particular, the process comparison and alignment tools provided herein can programmatically overlay multiple graphs and perform comparative analysis of their structures and data points. For example, overlaying multiple graphs allows for direct visual comparison of different experimental runs or process batches. In certain embodiments, by analyzing the structure of the overlaid graphs, the tools of the present disclosure can (e.g., automatically) identify differences and similarities between one or more processes and visually highlight them via the rendered graphs. For example, if one process deviates at a particular unit operation, the process comparison and alignment tools described herein can detect and flag this variation, e.g., via variations in the type, size, color, etc. of the icons used to represent the nodes. For example, in Figure 38I, the process variation is flagged with an enlarged, color-coded (orange) circle.

[0167] Additionally or alternatively, in certain embodiments, the disclosed process comparison and alignment tool can (e.g., automatically) compare data points from different graphs corresponding to different selected processes. For example, the disclosed system and method can automatically evaluate whether a particular data point is consistent across all processes or whether outliers exist that represent unexpected results and / or deviations from a particular desired tolerance. Metrics such as mean, median, standard deviation, variance, quartiles, etc., may be determined across the selected process and / or reference process (e.g., stored in a database) and individual data points from the particular process to compare against the metrics to determine whether those data points should be flagged, for example, based on whether they fall outside one or more standard deviations, above or below a particular quartile, etc. Such data points may be visually highlighted, for example, via variations in the type, size, color, etc. of the icon used to represent the node.

[0168] In certain embodiments, for example, following data comparison, data from corresponding points in the different processes can be extracted to create and export a harmonized dataset 3736. This harmonized dataset can then be used for further analysis, such as statistical testing or predictive modeling. For example, the harmonized dataset can be used as input for mathematical models that can predict outcomes, simulate different scenarios, or optimize the process. These models can be used to facilitate understanding the impact of different unit operations on the overall process and in making data-driven decisions to improve the process. Insights gained from mathematical modeling can be applied to refine the process, improve yield, or enhance quality, among other things. Understanding where deviations occur and their impact allows process engineers or chemists to make precise adjustments. Such an approach can be particularly useful in fields such as biotechnology, pharmaceuticals, and chemical engineering, where process control and optimization are important to ensure product quality and efficiency.

[0169] D. Experimental Process Design and Data Collection 39A-39D, in certain embodiments, the CMC technology of the present disclosure includes an experimental process design and data collection GUI to facilitate the design and management of manufacturing processes for pharmaceutical product manufacturing. Specifically, as shown in FIG. 39A, the experimental process design and data collection GUI 3906 can receive and / or access data from one or more pieces of equipment and / or databases used to perform various unit operations and render them in an informative and visually convenient manner to one or more users 3910. Additionally or alternatively, the experimental process design and data collection GUI 3906 can receive input from the user 3910, such as updating experimental control parameters, data analysis, parameters of the database 3904 and / or unit operation equipment 3902. Data can be rendered for and / or received from the user 3910 via various graphical widgets and / or subportions of the GUI 3906, which may be displayed, for example, as separate panels or sections within a single window, multiple subwindows, etc. These may include, for example, one or more of: (i) a real-time data display panel containing a graphical rendering of data obtained from and / or input into one or more connected devices used during a particular manufacturing process (e.g., to perform unit operations and / or collect measurements); (ii) a process design display panel containing a graphical rendering of one or more unit operations performed during the manufacturing process (e.g., as link tiles); (iii) a data entry and calculation panel containing a graphical rendering of multiple fields (e.g., text entry boxes) for entry of raw data and corresponding calculations; and (iv) a material preparation and data calculation panel containing a graphical rendering of multiple input fields and / or output calculations corresponding to material preparation inputs and calculations, as described in further detail herein.

[0170] i. Metadata and real-time display Figure 39B shows a screenshot of an exemplary format of GUI 3906, useful for, among other things, reviewing metadata and displaying real-time data. The GUI layout of Figure 39B includes a real-time data display panel occupying the top of the window, a data entry and calculation panel occupying the middle portion of the window, and a process design display panel occupying the bottom of the window.

[0171] Certain embodiments include a real-time data display panel that displays real-time data. It is set up to receive and show dynamically updated data from connected devices or operator input resulting from the execution of an experimental process. For example, the screenshot in Figure 39B shows elements such as "Plasmatherm3x10," "PRODIGY," and "PLI20," which represent equipment and / or processes that can be interfaced with to generate real-time data metrics.

[0172] The bottom section of the interface is dedicated to a process design display panel for designing the experimental process itself and collecting metadata. This outlines a series of unit operations from "starting material" to "freezing" and suggests a workflow for handling and processing materials. Each unit operation appears to have associated data entry fields, allowing the user to enter and track information such as the various unit operations provided to track and manage the use of specific materials and samples. The process flow is visually supported by icons and connecting lines, enhancing the user's ability to follow and manage the experimental protocol.

[0173] ii. Automatic in-process calculations and interfaces Figure 39C shows a screenshot of an exemplary format of GUI 3906 useful for, among other things, automated in-process calculations. The GUI layout in Figure 39C includes a real-time data display panel occupying the top of the window, a data entry and calculation panel occupying the middle portion of the window, and a process design display panel occupying the bottom portion of the window. This display is similar to that shown in Figure 39B, except that the "Data Calculation" option has been selected in the middle portion instead of "Data Entry."

[0174] The Data Entry and Calculations panel is geared toward automated in-process calculations, providing users with real-time calculation support for experimental data. This section includes fields for raw data entry and its corresponding calculations. Fields include timestamps, live and dead cell counts, sample volume, and viability, relevant to cell culture or biological sample analysis. It also features an area for "raw metadata" that can be used to process detailed manufacturing process metadata. It includes calculators and selection tools for different well plate formats, providing the ability to accommodate various experimental setups and different data entry requirements.

[0175] The "Tools" section may contain icons for different functions or modules within the software, such as data entry, calculations, and experiment configuration. The icons may represent actual equipment that can be connected to provide, for example, real-time data display.

[0176] The bottom of the GUI window also shows a process design display panel. Each unit operation in the process flow is paired with an interactive element, such as a drop-down menu or input field, to document and track the progression of materials through the experimental process.

[0177] iii. Material preparation and data calculation Figure 39D shows a screenshot of an exemplary format of GUI 3906 useful for, among other things, material preparation and data calculation. The layout is the same as that of Figures 39B and 39C, but now the center panel shows the material preparation and data calculation panel.

[0178] The Material Preparation and Data Calculations panel displays a table for material preparation calculations, facilitating user management of experiments requiring accurate measurement and tracking of reagents and materials. This table provides fields for input of various data points, such as stock concentrations, volumes per container, and number of containers, essential for accurately preparing experimental materials. In certain embodiments, the GUI 3906 can guide users to interact with the software correctly using color-coded warnings, such as "Do not modify gray or yellow cells," and can suggest built-in safeguards or validation rules to ensure data integrity.

[0179] In certain embodiments, GUI 3906 can be used for multi-well experiments, and Figure 39D shows detailed input fields and calculated data for different time points, such as days 0, 7, and 11. The table contains comprehensive data such as experimental concentrations, volumes per vessel, and total volumes, allowing for complex management of experimental conditions over time.

[0180] Thus, among other things, the various combinations of visual elements and the interactive nature of the interface described herein provide a streamlined and efficient workflow for laboratory experiments.

[0181] In particular, the GUI shown in Figures 39A-D combines static process designer charts with dynamic data display, input, and calculation capabilities, allowing users to easily inspect and analyze, in near real time, data being collected and / or input at various unit operations across a complex manufacturing process. Specifically, users can select a specific unit operation by selecting a linked tile displayed at the bottom of the interface. The upper portion of the interface, the data display, input, and / or calculation portions, then update to reflect data relevant to the specific selected unit operation, as guided, for example, by custom ontologies stored in the knowledge base described herein. This allows users to read and manipulate data in real time, ensure data is collected completely and in a timely manner, and input missing data as needed. This approach facilitates and expedites complex and time-consuming data management activities in the context of pharmaceutical product manufacturing.

[0182] E. Software, Computer Systems, and Network Environments Certain embodiments described herein utilize computer algorithms in the form of software instructions executed by a computer processor. In certain embodiments, the software instructions include a machine learning module, also referred to herein as artificial intelligence software. As used herein, a machine learning module refers to a computer-implemented process (e.g., software function) that implements one or more specific machine learning algorithms, such as, for example, an artificial neural network (ANN), a random forest, a decision tree, a support vector machine, etc., to determine one or more output values ​​for a given input. In certain embodiments, the input includes alphanumeric data, which may include, for example, a number, a word, a phrase, or a longer string of characters. In certain embodiments, the one or more output values ​​include values ​​representing a number, a word, a phrase, or other alphanumeric string. In certain embodiments, the one or more output values ​​include the identification of one or more response strings (e.g., selected from a database).

[0183] For example, a machine learning module can receive as input a text string (e.g., entered by a human user) and generate various outputs. For example, the machine learning module can automatically analyze the input alphanumeric string(s) to determine an output value that classifies the content (e.g., intent) of the text, e.g., as in natural language understanding (NLU). In particular embodiments, the text string is analyzed to generate and / or search an output alphanumeric string. For example, the machine learning module can be (or include) natural language processing (NLP) software.

[0184] In certain embodiments, a machine learning module implementing machine learning techniques is trained using a dataset including, for example, the categories of data described herein. Such training can be used to determine various parameters of the machine learning algorithm implemented by the machine learning module, such as weights associated with layers in a neural network. In certain embodiments, once a machine learning module is trained to accomplish a particular task, such as identifying a particular response string, the determined parameter values ​​are fixed (e.g., unchanging, static), and the machine learning module is used to process new data (e.g., different from the training data) and accomplish its trained task without further updating its parameters (e.g., the machine learning module does not receive feedback and / or updates). In certain embodiments, the machine learning module can receive feedback based, for example, on user reviews of accuracy, and such feedback can be used as additional training data to dynamically update the machine learning module. In certain embodiments, two or more machine learning modules can be combined and executed as a single module and / or a single software application. In certain embodiments, two or more machine learning modules can be implemented separately, for example, as separate software applications. The machine learning modules can be software and / or hardware. For example, the machine learning module may be implemented entirely as software, or certain functions of the ANN module may be performed via dedicated hardware (e.g., via an application specific integrated circuit (ASIC)).

[0185] As shown in FIG. 40 , an implementation of a network environment 4000 for use in providing the systems, methods, and architectures described herein is shown and described. Briefly, referring now to FIG. 40 , a block diagram of an exemplary cloud computing environment 4000 is shown and described. The cloud computing environment 4000 may include one or more resource providers 4002 a, 4002 b, 4002 c (collectively, 4002). Each resource provider 4002 may include computing resources. In some embodiments, computing resources may include any hardware and / or software used to process data. For example, computing resources may include hardware and / or software capable of executing algorithms, computer programs, and / or computer applications. In some embodiments, exemplary computing resources may include application servers and / or databases with storage and retrieval capabilities. Each resource provider 4002 may be connected to any other resource providers 4002 in the cloud computing environment 4000. In some embodiments, the resource providers 4002 may be connected via a computer network 4008. Each resource provider 4002 may be connected to one or more computing devices 4004 a , 4004 b , 4004 c (collectively, 4004 ) via a computer network 4008 .

[0186] The cloud computing environment 4000 may include a resource manager 4006. The resource manager 4006 may be connected to the resource providers 4002 and the computing devices 4004 via a computer network 4008. In some implementations, the resource manager 4006 may facilitate the provision of computing resources by one or more resource providers 4002 to one or more computing devices 4004. The resource manager 4006 may receive a request for a computing resource from a particular computing device 4004. The resource manager 4006 may identify one or more resource providers 4002 that can provide the computing resource requested by the computing device 4004. The resource manager 4006 may select a resource provider 4002 that provides the computing resource. The resource manager 4006 may facilitate a connection between a resource provider 4002 and a particular computing device 4004. In some implementations, the resource manager 4006 may establish a connection between a particular resource provider 4002 and a particular computing device 4004. In some implementations, the resource manager 4006 may redirect a particular computing device 4004 to a particular resource provider 4002 that has the requested computing resource.

[0187] 41 illustrates examples of a computing device 4100 and a mobile computing device 4150 that can be used to implement the techniques described in this disclosure. The computing device 4100 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other suitable computers. The mobile computing device 4150 is intended to represent various forms of mobile devices, such as personal digital assistants, mobile phones, smartphones, and other similar computing devices. The components, their connections and relationships, and their functions shown here are for illustrative purposes only and are not meant to be limiting.

[0188] The computing device 4100 includes a processor 4102, a memory 4104, a storage device 4106, a high-speed interface 4108 connecting to the memory 4104 and multiple high-speed expansion ports 4110, and a low-speed interface 4112 connecting to a low-speed expansion port 4114 and the storage device 4106. Each of the processor 4102, the memory 4104, the storage device 4106, the high-speed interface 4108, the high-speed expansion port 4110, and the low-speed interface 4112 are interconnected using various buses and may be mounted on a common motherboard or otherwise, as desired. The processor 4102 can process instructions, including instructions stored in the memory 4104 or the storage device 4106, for execution within the computing device 4100 to display graphical information for a GUI on an external input / output device, such as a display 4116 coupled to the high-speed interface 4108. In other implementations, multiple processors and / or multiple buses may be used, as desired, along with multiple memories and types of memory. Also, multiple computing devices can be connected, with each device providing a portion of the required operations (e.g., as a server bank, a group of blade servers, or a multiprocessor system). Thus, as the terms are used herein, when functions are described as being performed by a "processor," this encompasses embodiments in which the functions are performed by any number of processors in any number of computing device(s). Furthermore, when functions are described as being performed by a "processor," this encompasses embodiments in which the functions are performed by any number of processors in any number of computing device(s) (e.g., in a distributed computing system).

[0189] The memory 4104 stores information within the computing device 4100. In some implementations, the memory 4104 is a volatile memory unit(s). In some implementations, the memory 4104 is a non-volatile memory unit(s). The memory 4104 may also be another form of computer-readable medium, such as a magnetic or optical disk.

[0190] The storage device 4106 can provide mass storage for the computing device 4100. In some implementations, the storage device 4106 can be or contain a computer-readable medium, such as a floppy disk drive, a hard disk drive, an optical disk drive, or a tape drive, a flash memory or other similar solid-state memory device, or an array of devices, including devices in a storage area network or other configuration. The instructions can be stored on an information carrier. When executed by one or more processing devices (e.g., the processor 4102), the instructions perform one or more methods, such as those described above. The instructions can also be stored by one or more storage devices (e.g., the memory 4104, the storage device 4106, or memory on the processor 4102), such as a computer-readable or machine-readable medium.

[0191] The high-speed interface 4108 manages bandwidth-intensive operations of the computing device 4100, while the low-speed interface 4112 manages less bandwidth-intensive operations. This allocation of functionality is by way of example only. In some implementations, the high-speed interface 4108 is coupled to the memory 4104, the display 4116 (e.g., via a graphics processor or accelerator), and is coupled to a high-speed expansion port 4110 that can accept various expansion cards (not shown). In some implementations, the low-speed interface 4112 is coupled to the storage device 4106 and the low-speed expansion port 4114. The low-speed expansion port 4114, which may include various communication ports (e.g., USB, Bluetooth, Ethernet, wireless Ethernet), may be coupled, for example, via a network adapter, to one or more input / output devices such as a keyboard, pointing device, scanner, or a networking device such as a switch or router.

[0192] The computing device 4100, as shown in the figure, may be implemented in many different forms. For example, it may be implemented multiple times as a standard server 4120 or within a group of such servers. Furthermore, the present invention may be implemented in a personal computer, such as a laptop computer 4122, or as part of a rack server system 4124. Alternatively, components from the computing device 4100 may be combined with other components in a mobile device (not shown), such as a mobile computing device 4150. Each such device may include one or more of the computing device 4100 and the mobile computing device 4150, and the entire system may be composed of multiple computing devices communicating with each other.

[0193] The mobile computing device 4150 includes, among other components, a processor 4152, memory 4164, an input / output device such as a display 4154, a communication interface 4166, and a transceiver 4168. The mobile computing device 4150 may also include a storage device such as a microdrive or other device to provide additional storage. Each of the processor 4152, memory 4164, display 4154, communication interface 4166, and transceiver 4168 are interconnected using various buses, and some of the components may be mounted on a common motherboard or otherwise, if desired.

[0194] The processor 4152 can execute instructions within the mobile computing device 4150, including instructions stored in the memory 4164. The processor 4152 can be implemented as a discrete processor and a chipset of chips including multiple analog and digital processors. The processor 4152 can provide coordination of other components of the mobile computing device 4150, such as control of a user interface, applications executed by the mobile computing device 4150, and wireless communication by the mobile computing device 4150.

[0195] The processor 4152 can communicate with a user through a control interface 4158 coupled to a display 4154 and a display interface 4156. The display 4154 can be, for example, a TFT (thin film transistor liquid crystal display) display, an OLED (organic light emitting diode) display, or other suitable display technology. The display interface 4156 can include appropriate circuitry for driving the display 4154 to present graphics and other information to the user. The control interface 4158 can receive commands from the user and convert them for submission to the processor 4152. Additionally, an external interface 4162 can provide communication with the processor 4152 to enable short-range communication between the mobile computing device 4150 and other devices. The external interface 4162 can provide, for example, wired communication in some implementations or wireless communication in other implementations; multiple interfaces can also be used.

[0196] The memory 4164 stores information within the computing device 4150. The memory 4164 may be implemented as one or more of a computer-readable medium(s), a volatile memory unit(s), or a non-volatile memory unit(s). Expansion memory 4174 may also be provided and connected to the mobile computing device 4150 through an expansion interface 4172, which may include, for example, a SIMM (single in-line memory module) card interface. The expansion memory 4174 may provide additional storage space for the mobile computing device 4150 or may also store applications or other information for the mobile computing device 4150. Specifically, the expansion memory 4174 may include instructions that perform or complement the processes described above and may also include secure information. Thus, for example, the expansion memory 4174 may be provided in the mobile computing device 4150 as a security module and may be programmed with instructions that enable secure use of the mobile computing device 4150. Additionally, secure applications may be provided via SIMM cards with additional information, such as placing identifying information on the SIMM card in a non-hackable manner.

[0197] The memory may include, for example, flash memory and / or NVRAM memory (non-volatile random access memory), as discussed below. In some embodiments, the instructions are stored on an information carrier. When executed by one or more processing devices (e.g., processor 4152), the instructions perform one or more methods, such as those described above. The instructions may also be stored by one or more storage devices, such as one or more computer-readable or machine-readable media (e.g., memory 4164, expansion memory 4174, or memory on processor 4152). In some implementations, the instructions may be received in a propagated signal, for example, via transceiver 4168 or external interface 4162.

[0198] The mobile computing device 4150 may communicate wirelessly via the communication interface 4166, which may include digital signal processing circuitry as needed. The communication interface 4166 may provide communications under various modes or protocols, including, among others, GSM (Global System for Mobile Communications), voice calling, SMS (Short Message Service), EMS (Enhanced Messaging Service), or MMS messaging (Multimedia Messaging Service), CDMA (Code Division Multiple Access), TDMA (Time Division Multiple Access), PDC (Personal Digital Cellular), WCDMA (Wideband Code Division Multiple Access), CDMA2000, or GPRS (General Packet Radio Service). Such communications may occur, for example, via the transceiver 4168 using radio frequencies. Additionally, short-range communications may occur, such as using Bluetooth, Wi-Fi, or other such transceivers (not shown). Additionally, a GPS (Global Positioning System) receiver module 4170 can provide additional navigation and location-related radio data to the mobile computing device 4150, which can be used as appropriate by applications running on the mobile computing device 4150.

[0199] The mobile computing device 4150 can also communicate audibly using an audio codec 4160, which can receive spoken information from a user and convert it into usable digital information. The audio codec 4160 can also generate audible sounds for the user, such as via a speaker in a handset of the mobile computing device 4150. Such sounds can include sounds from a voice call, recorded sounds (e.g., voice messages, music files, etc.), and sounds generated by applications running on the mobile computing device 4150.

[0200] The mobile computing device 4150 may be implemented in many different forms, as shown in the figure, for example as a mobile phone 4180, or as part of a smartphone 4182, personal digital assistant, or other similar mobile device.

[0201] Various implementations of the systems and techniques described herein may be realized in digital electronic circuitry, integrated circuits, specially designed ASICs (application-specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations may include implementation in one or more computer programs executable and / or interpretable on a programmable system including at least one programmable processor, which may be special-purpose or general-purpose, coupled to receive or transmit data and instructions from or to a storage system, at least one input device, and at least one output device.

[0202] These computer programs (also known as programs, software, software applications, or code) include machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages, and / or assembly / machine languages. As used herein, the terms machine-readable medium and computer-readable medium refer to any computer program product, apparatus, and / or device (e.g., magnetic disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives the machine instructions as a machine-readable signal. The term machine-readable signal refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0203] To provide for user interaction, the systems and techniques described herein are implemented on a computer that has a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user, and a keyboard and pointing device (e.g., a mouse or trackball) by which the user can provide input to the computer. Other types of devices can also be used to provide for user interaction. For example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback), and input from the user can be received in any form, such as acoustic, verbal, or tactile input.

[0204] The systems and techniques described herein can be implemented in a computing system that includes back-end components (e.g., a data server), or a computing system that includes middleware components (e.g., as an application server), or a computing system that includes front-end components (e.g., a client computer having a graphical user interface or web browser through which a user can interact with an implementation of the systems and techniques described herein), or any combination of such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (LAN), a wide area network (WAN), and the Internet.

[0205] A computing system may include clients and servers. Clients and servers are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and by virtue of the client-server relationship they have to each other.

[0206] In some implementations, particular modules described herein may be separated, combined, or incorporated into a single module or combined modules. Any modules shown in the figures are not intended to limit the systems described herein to the software architectures shown herein.

[0207] Elements of different embodiments described herein may be combined to form other embodiments not specifically described above. Elements may be omitted from the processes, computer programs, databases, etc. described herein without adversely affecting their operation. Furthermore, the logic flow depicted in the figures does not require the particular order or sequential order shown to achieve desirable results. Various separate elements may be combined into one or more individual elements to perform the functions described herein.

[0208] While the present invention has been shown and described with reference to certain preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the true spirit and scope of the invention as defined in the appended claims. (Item 1) 1. A method of using heterogeneous, structured data of an enterprise in the development and / or manufacture of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the method comprising: (a) receiving, by a processor of a computing device, a user query via a portal (e.g., a web-based portal), the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing (e.g., via a federating server) multiple data sources having heterogeneous data formats and retrieving integrated results (e.g., combining data from multiple sources and resolving one or more inconsistencies), the response to the user query including the integrated results; (c) graphically rendering the response to the user query. (Item 2) 2. The method of claim 1, wherein the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data. (Item 3) 3. The method of claim 1 or 2, wherein step (c) includes updating a process monitoring graphical display (e.g., a monitoring dashboard) with the response to the user query in real time (e.g., near real time). (Item 4) 10. The method of any one of the preceding items, wherein the plurality of data sources accessed by the VDIS includes live data (e.g., data that is updated in real time). (Item 5) 10. The method of claim 1, wherein step (c) comprises graphically rendering a digital page comprising a plurality of sentences and / or paragraphs of text, the digital page also comprising user-interactive data (e.g., tile data) associated with the text, the data being updated to reflect the response to the user query. (Item 6) 10. The method of any one of the preceding items, wherein the view-based data integration system includes a both-as-view (BAV) (also known as global and local as view (GLAV)) backend infrastructure. (Item 7) 10. The method of any one of the preceding items, wherein the view-based data integration system includes a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure. (Item 8) 10. The method of claim 1, wherein the mediator converts the user query into a plurality of source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates the response to the query. (Item 9) 9. The method according to any one of items 6 to 8, wherein the backend infrastructure comprises multiple sources containing heterogeneous structured data that are integrated into a unified view. (Item 10) 10. The method of any one of the preceding items, wherein the method uses a graph-based real-time digitization and contextualization engine. (Item 11) 10. The method of claim 1, wherein the plurality of data sources having heterogeneous data formats accessed by the VDIS includes at least one data source, the data of which is automatically reconciled at the time of data collection. (Item 12) Item 12. The method of item 11, wherein the at least one data source automatically harmonizes its data by restricting data entry to a number of predetermined fields and / or values. (Item 13) 10. The method of claim 9, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface (e.g., a process director display) including one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is contained in at least one of the plurality of data sources accessed by the VDIS, and wherein the one or more blocks are dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS. (Item 14) 10. The method of claim 1, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface (e.g., a process designer) comprising one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is contained in at least one of the plurality of data sources accessed by the VDIS; wherein the one or more blocks can be linked together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks; and wherein the one or more blocks are dynamic such that upon user interaction with the particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the unit operation represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS. (Item 15) 10. The method of claim 9, wherein step (c) comprises graphically rendering the response to the query via a graphical user interface (e.g., patient tiles) including a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of the plurality of data sources accessed by the VDIS (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and wherein one or more of the tiles are dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data about the subject represented by the particular tile, the additional data being included in at least one of the plurality of data sources accessed by the VDIS. (Item 16) 3. The method of any one of the preceding items, wherein step (c) includes graphically rendering the response to the user query via a graphical user interface (e.g., substantially as rendered in FIGS. 4A-34J). (Item 17) 1. A method of using company data in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the method comprising: (a) receiving, by a processor of a computing device, a user query via a portal (e.g., a web-based portal), the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (b) communicating the user query to a database management system to generate a response to the user query, wherein the database management system accesses multiple data sources (e.g., via a federating server) to retrieve results (e.g., combine data from multiple sources and resolve one or more inconsistencies to generate an integrated result), and the response to the user query includes the results; (c) graphically rendering the response to the user query; The method, wherein the plurality of data sources accessed by the database management system includes at least one data source, the data of which is automatically harmonized at the time of data collection by restricting data entry to a plurality of predetermined fields and / or values. (Item 18) 18. The method of claim 17, wherein the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data. (Item 19) Item 19. The method of item 17 or 18, wherein step (c) includes updating a process monitoring graphical display (e.g., a monitoring dashboard) with the response to the user query in real time (e.g., near real time). (Item 20) 20. The method of any one of items 17 to 19, wherein the plurality of data sources accessed by the database management system includes live data (e.g., data that is updated in real time). (Item 21) 21. The method of any one of items 17 to 20, wherein step (c) comprises graphically rendering a digital page comprising a plurality of sentences and / or paragraphs of text, the digital page also comprising user-interactive data (e.g., tile data) associated with the text, the data being updated to reflect the response to the user query. (Item 22) 22. The method according to any one of items 17 to 21, wherein the method uses a graph-based real-time digitization and contextualization engine. (Item 23) 23. The method of any one of items 17 to 22, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface (e.g., a process director display) comprising one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein the one or more blocks are dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system. (Item 24) 24. The method of any one of items 17 to 23, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface (e.g., a process designer) comprising one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is contained in at least one of the plurality of data sources accessed by the database management system, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed conveying to the user additional data regarding the unit operation represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system. (Item 25) 25. The method of any one of items 17 to 24, wherein step (c) comprises graphically rendering the response to the query via a graphical user interface (e.g., patient tiles) including a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is contained in at least one of the plurality of data sources accessed by the database management system (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and wherein one or more of the tiles are dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user about the subject represented by the particular tile, the additional data being contained in at least one of the plurality of data sources accessed by the database management system. (Item 26) 26. The method of any one of items 17 to 25, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface (e.g., substantially as rendered in Figures 4A to 34J). (Item 27) 1. A system for using heterogeneous, structured data of an enterprise in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the system comprising: a processor of a computing device; and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receiving a user query via a portal (e.g., a web-based portal), the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing (e.g., via a federating server) multiple data sources having heterogeneous data formats and retrieving integrated results (e.g., combining data from multiple sources and resolving one or more inconsistencies), the response to the user query including the integrated results; (c) graphically rendering the response to the user query. (Item 28) 28. The system of claim 27, wherein the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data. (Item 29) 29. The system of claim 27 or 28, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to update a process monitoring graphical display (e.g., a monitoring dashboard) with the response to the user query in real time (e.g., near real time). (Item 30) 30. The system of any one of items 27 to 29, wherein the plurality of data sources accessed by the VDIS includes live data (eg, data that is updated in real time). (Item 31) 31. The system of any one of items 27-30, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render a digital page including a plurality of sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, the data being updated to reflect the response to the user query. (Item 32) 32. The system of any one of items 27 to 31, wherein the view-based data integration system includes a both-as-view (BAV) [also known as global and local as view (GLAV)] backend infrastructure. (Item 33) 33. The system of any one of items 27 to 32, wherein the view-based data integration system includes a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure. (Item 34) 34. The system of any one of items 27 to 33, wherein the mediator converts the user query into multiple source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates the response to the query. (Item 35) 35. The system of any one of items 32 to 34, wherein the backend infrastructure includes multiple sources containing heterogeneous structured data that are integrated into a unified view. (Item 36) 36. The system of any one of items 27 to 35, wherein the system uses a graph-based real-time digitization and contextualization engine. (Item 37) 37. The system of any one of items 27 to 36, wherein the plurality of data sources having heterogeneous data formats accessed by the VDIS includes at least one data source, the data of which is automatically reconciled at the time of data collection. (Item 38) Item 38. The system of item 37, wherein the at least one data source automatically harmonizes its data by restricting data entry to a number of predetermined fields and / or values. (Item 39) 39. The system of any one of items 27-38, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., a process director display) including one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is included in at least one of the multiple data sources accessed by the VDIS, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the process step represented by the particular block, the additional data being included in at least one of the multiple data sources accessed by the VDIS. (Item 40) 40. The system of any one of items 27-39, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., a process designer) including one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is included in at least one of the multiple data sources accessed by the VDIS, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the multiple unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the unit operation represented by the particular block, the additional data being included in at least one of the multiple data sources accessed by the VDIS. (Item 41) 41. The system of any one of items 27-40, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the query via a graphical user interface (e.g., patient tiles) including a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of the plurality of data sources accessed by the VDIS (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and wherein one or more of the tiles are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data about the subject represented by the particular tile, the additional data being included in at least one of the plurality of data sources accessed by the VDIS. (Item 42) 42. The system of any one of items 27-41, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., substantially as rendered in Figures 4A-34J). (Item 43) 1. A system for using data from a company in the development and / or manufacturing of a pharmaceutical product (e.g., a cell therapy product, e.g., natural killer (NK) cells, T cells, iPS-derived CAR T cells, gamma-delta (GD) T cells, or stem cells), the system comprising: a processor of a computing device; and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receiving a user query via a portal (e.g., a web-based portal), the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (ii) operating (e.g., process monitoring and / or process control) a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); and (iii) modeling a manufacturing process for producing the pharmaceutical product (e.g., the cell therapy product); (b) communicating the user query to a database management system to generate a response to the user query, wherein the database management system accesses multiple data sources (e.g., via a federating server) to retrieve results (e.g., combine data from multiple sources and resolve one or more inconsistencies to generate an integrated result), and the response to the user query includes the results; (c) graphically rendering the response to the user query; The system, wherein the multiple data sources accessed by the database management system include at least one data source, the data of which is automatically harmonized at the time of data collection by restricting data entry to a plurality of predetermined fields and / or values. (Item 44) 44. The method of claim 43, wherein the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data (e.g., results), (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data. (Item 45) 45. The system of claim 43 or 44, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to update a process monitoring graphical display (e.g., a monitoring dashboard) with the response to the user query in real time (e.g., near real time). (Item 46) 46. ​​The system of any one of items 43 to 45, wherein the plurality of data sources accessed by the database management system includes live data (eg, data that is updated in real time). (Item 47) 47. The system of any one of items 43-46, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render a digital page including a plurality of sentences and / or paragraphs of text, the digital page also including user-interactive data (e.g., tile data) associated with the text, the data being updated to reflect the response to the user query. (Item 48) 48. The system of any one of items 43 to 47, wherein the system uses a graph-based real-time digitization and contextualization engine. (Item 49) 49. The system of any one of items 43-48, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., a process director display) including one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a step in a particular experimental and / or manufacturing process, the data (e.g., live data) for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system. (Item 50) 50. The system of any one of items 43-49, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., a process designer) including one or more linked blocks (e.g., a type of graphical widget, e.g., a tile), each block representing a unit operation in a particular experimental and / or manufacturing process, the data (e.g., live data) of which is included in at least one of the multiple data sources accessed by the database management system, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the multiple unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data regarding the unit operation represented by the particular block, the additional data being included in at least one of the multiple data sources accessed by the database management system. (Item 51) 51. The system of any one of items 43 to 50, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the query via a graphical user interface (e.g., patient tiles) including a plurality of tiles (e.g., a type of graphical widget), each tile representing a particular subject (e.g., a patient in a clinical trial) whose data (e.g., live data) is included in at least one of the plurality of data sources accessed by the database management system (e.g., the tiles have different colors, shading, line styles, etc. to visually convey data about the subject, e.g., to convey clinical response), and wherein one or more of the tiles are dynamic such that upon user interaction (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction) with a particular block, a pop-up window (e.g., an expandable pop-up) is displayed to convey to the user additional data about the subject represented by the particular tile, the additional data being included in at least one of the plurality of data sources accessed by the database management system. (Item 52) 52. The system of any one of items 43-51, wherein the instructions, when executed by the processor, cause the processor (e.g., in step (c)) to graphically render the response to the user query via a graphical user interface (e.g., substantially as rendered in Figures 4A-34J). (Item 53) 1. A method for facilitating user management of a manufacturing process (e.g., an experimental (e.g., lab or pilot scale) process developed for / in the design of a manufacturing process; e.g., a commercial scale production process) for producing a pharmaceutical product (e.g., a cell therapy product, e.g., a biological agent) via an interactive manufacturing management graphical user interface (GUI), the method comprising: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a plurality of unit operations in a particular manufacturing process, said data representing (i) actions performed in said plurality of unit operations, and / or (ii) information collected about said plurality of unit operations (e.g., information collected before, during, and / or after one or more of said plurality of unit operations is performed); and (b) causing the processor to render, via the manufacturing control GUI, a graph-based visualization of the particular manufacturing process, the graph-based visualization including a plurality of interactive nodes (e.g., graphical icons such as (e.g., color-coded) interconnected circular icons), each of which represents (i) an individual data point corresponding to a particular action performed at one of the plurality of unit operations, and / or (ii) a particular set of information collected for a particular one of the plurality of unit operations (e.g., information collected before, during, and / or after a particular unit operation) (e.g., one or more of the interactive nodes are linked (e.g., connected to each other), with each link between a first and second interactive node representing a dependency and / or sequence of material and / or data flow (e.g., each link is graphically rendered as a line connecting two graphical nodes representing nodes). (Item 54) Item 54. The method of item 53, wherein the graph-based visualization includes a timeline (e.g., vertical or horizontal lines, markings (e.g., labeled) along the line representing days and / or unit operations) showing days (e.g., days on which the particular manufacturing process is carried out) and / or unit operations (e.g., of the particular manufacturing process), and wherein each interactive node of the plurality of interactive nodes is visually associated with a particular one of the days and / or unit operations in the timeline (e.g., positioned in the graph-based visualization proximate to and along the same horizontal and / or vertical axis as the particular day and / or unit operation). (Item 55) 55. The method of claim 53 or 54, wherein the graph-based visualization includes a base graph corresponding to and representing a baseline version of the manufacturing process, together with one or more auxiliary sub-graphs, each sub-graph corresponding to and representing an experimental condition and / or variation of the baseline version of the manufacturing process (e.g., the one or more auxiliary sub-graphs are displayed below the base graph (e.g., each auxiliary sub-graph includes one or more icons representing nodes and connecting lines representing links between nodes, which in turn represent unit operations and materials and / or data flows therebetween, respectively)). (Item 56) 56. The method of any one of items 53-55, wherein the plurality of interactive nodes are dynamic, such that upon user interaction with a particular interactive node (e.g., via a mouse click or hover, e.g., via a tap or other touchscreen-based interaction), a pop-up window (e.g., an expandable pop-up) is displayed to convey additional data to the user regarding the data point represented by the particular interactive node (e.g., the additional data is contained in at least one of the plurality of data sources accessed by the VDIS). (Item 57) 57. The method of any one of items 54 to 56, comprising rendering a plurality of data point indicators for each of one or more data parameters and / or variables controlled and / or monitored during the particular manufacturing process, each data point indicator representing a collected and / or entered value of the data parameter and / or variable at a particular timepoint and / or unit operation during the particular manufacturing process. (Item 58) 58. The method of claim 57, wherein the plurality of data point indicators are color coded according to whether data has been collected, is missing, and / or is selected for further analysis. (Item 59) receiving, by the processor, a user selection of at least some of the data points via the GUI (e.g., via a user click); and generating, by the processor, an interactive graph plotting the values ​​of the selected data points. (Item 60) Item 59. The method of item 59, wherein the manufacturing process data includes multiple sets of values ​​for the one or more data parameters and / or variables controlled and / or monitored during the particular manufacturing process, each set of values ​​being associated with a separate lot and / or batch, and the interactive graph includes multiple traces (e.g., lines, a collection of points (e.g., as in a scatter plot), a series of bars (e.g., as in a bar graph), graphic icons (e.g., pictograms), etc.; e.g., as shown in any of Figures 20A-28F), each trace corresponding to and showing the progression of a set of values ​​for the particular lot and / or batch with which the set is associated. (Item 61) receiving and / or accessing, by the processor, additional manufacturing process data corresponding to one or more additional manufacturing processes; 61. The method of any one of items 53 to 60, comprising: causing the processor to render one or more additional graph-based visualizations, each representing a particular one of the one or more additional manufacturing processes within the manufacturing control GUI, wherein the one or more additional graph-based visualizations align and / or overlay with the graph-based visualization corresponding to the particular manufacturing process. (Item 62) Item 62. The method of item 61, wherein rendering the one or more additional graph-based visualizations comprises automatically highlighting deviations between the one or more processes and / or deviations from norms (e.g., visually rendering nodes and / or lines connecting them representing unit operations that (i) differ from those of other processes and / or (ii) have one or more parameters and / or collected data that deviate from norms and / or ranges of norms). (Item 63) 63. The method of claim 61 or 62, comprising generating and outputting a harmonized data set corresponding to the particular manufacturing process and the one or more additional manufacturing processes (e.g., for subsequent mathematical modeling) (e.g., identifying data points that are consistent and / or outliers (e.g., automatically and / or based on user input and / or selection) and then extracting a portion of the data points (identified as consistent) to generate the harmonized data set). (Item 64) receiving, by the processor, via the manufacturing management GUI, a user selection of one or more nodes for inclusion in a harmonized data set and / or user data input for one or more nodes of the graph-based visualization and / or one or more additional graph-based visualizations; and generating, by the processor, a harmonized dataset based at least in part on the user selection and / or data input (e.g., a dataset in which the user selected nodes and / or originally stored data have been replaced with the user input). (Item 65) 1. A method for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, comprising: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a particular manufacturing process and representing operations performed (e.g., unit operations in the particular manufacturing process) and / or information collected during the particular manufacturing process; (b) causing the processor to graphically render one or more interactive panels representing the operations during the manufacturing process and / or information collected during the manufacturing process, the one or more interactive panels including one or more (e.g., up to all) of the following: (i) a real-time data display panel containing a graphical rendering of data obtained from and / or input into one or more connected devices used (e.g., to perform unit operations and / or collect measurements) during the particular manufacturing process; (ii) a process design display panel (e.g., as link tiles) containing a graphical rendering of one or more unit operations performed during said manufacturing process; (iii) a data entry and calculation panel that includes a graphical rendering of multiple fields (e.g., text entry boxes) for entry of raw data and corresponding calculations; and (iv) a material preparation and data calculation panel including a graphical rendering of multiple input fields and / or output calculations corresponding to material preparation inputs and calculations; (Item 66) Item 66. The method of item 65, wherein a unit operation includes causing a graphical rendering of the real-time data display panel according to variations in values ​​of parameters input to and / or collected from one or more interconnected devices, and dynamically updating the real-time data display panel. (Item 67) Step (b) generating, by the processor, a graphical rendering of the process design panel, the process design panel including one or more selectable icons (e.g., link tiles), each representing a particular unit operation in the manufacturing process; receiving, by the processor, a user selection of a particular unit operation for data review and / or entry via a corresponding user interaction of one or more selectable icons within the process design panel; and 67. The method of claim 65 or 66, further comprising: updating, by the processor, one or more of the real-time data display panel, the data entry and calculation panel, and the material preparation and data calculation panel to reflect data associated with a particular unit operation (e.g., collected during and / or entered into the particular unit operation) (e.g., the updating includes identifying a set of data associated with the particular unit operation (e.g., and the particular manufacturing process) in one or more databases (e.g., knowledge bases) based on a stored ontology that links unit operations, manufacturing processes, input parameters, and collected data in a relational manner (e.g., in a hierarchical manner, e.g., via a knowledge graph)). (Item 68) 1. A system for facilitating user management of a manufacturing process (e.g., an experimental (e.g., lab or pilot scale) process developed for / in the design of a manufacturing process; e.g., a commercial scale production process) for producing a pharmaceutical product (e.g., a cell therapy product, e.g., a biological agent) via an interactive manufacturing management graphical user interface (GUI), the system comprising: a processor of a computing device; and a memory having instructions stored thereon, the instructions, when executed by the processor, causing the processor to: (a) receiving and / or accessing manufacturing process data corresponding to a plurality of unit operations in a particular manufacturing process and representing actions performed in the plurality of unit operation manufacturing process and / or information collected about the plurality of unit operations in the particular manufacturing process (e.g., information collected before, during, and / or after one or more of the plurality of unit operations is performed); and (b) causing the rendering of a graph-based visualization of the particular manufacturing process via the manufacturing management GUI, the graph-based visualization including a plurality of interactive nodes (e.g., graphical icons such as (e.g., color-coded) interconnected circular icons), each interactive node of the plurality of interactive nodes representing an individual data point corresponding to a particular action performed in one of the plurality of unit operations and / or a particular set of information collected for a particular one of the plurality of unit operations (e.g., information collected before, during, and / or after a particular unit operation). (Item 69) 1. A system for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, the system comprising: a processor of a computing device; and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receiving and / or accessing manufacturing process data corresponding to a particular manufacturing process and representing operations performed (e.g., unit operations in the particular manufacturing process) and / or information collected during the particular manufacturing process; (b) graphically rendering one or more interactive panels representing the operations during the manufacturing process and / or information collected during the manufacturing process, wherein the one or more interactive panels include one or more (e.g., up to all) of the following: (i) a real-time data display panel containing a graphical rendering of data obtained from and / or input into one or more connected devices used (e.g., to perform unit operations and / or collect measurements) during the particular manufacturing process; (ii) a process design display panel (e.g., as link tiles) containing a graphical rendering of one or more unit operations performed during said manufacturing process; (iii) a data entry and calculation panel that includes a graphical rendering of multiple fields (e.g., text entry boxes) for entry of raw data and corresponding calculations; and (iv) a material preparation and data calculation panel including a graphical rendering of multiple input fields and / or output calculations corresponding to material preparation inputs and calculations;

Claims

1. 1. A method for using heterogeneous, structured data of an enterprise in pharmaceutical product development and / or manufacturing, said method comprising: (a) receiving, by a processor of a computing device, a user query via a portal, the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product; (ii) operating a manufacturing process for producing the pharmaceutical product; and (iii) modeling a manufacturing process for producing the pharmaceutical product; (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing multiple data sources having heterogeneous data formats to retrieve integrated results, and the response to the user query including the integrated results; (c) graphically rendering the response to the user query.

2. 10. The method of claim 1, wherein the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data, (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

3. 3. The method of claim 1, wherein step (c) includes updating a process monitoring graphical display with the response to the user query in real time.

4. 10. The method of any one of the preceding claims, wherein the plurality of data sources accessed by the VDIS includes live data.

5. 10. A method according to any one of the preceding claims, wherein step (c) comprises graphically rendering a digital page comprising a plurality of sentences and / or paragraphs of text, said digital page also comprising user interactive data associated with said text, said data being updated to reflect said response to said user query.

6. 10. The method of any one of the preceding claims, wherein the view-based data integration system comprises a both-as-view (BAV) backend infrastructure.

7. 10. The method of any one of the preceding claims, wherein the view-based data integration system comprises a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure.

8. 10. The method of claim 1, wherein the mediator converts the user query into a plurality of source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates the response to the query.

9. The method of any one of claims 6 to 8, wherein the backend infrastructure comprises multiple sources containing heterogeneous structured data that are integrated into a unified view.

10. 10. The method of any one of the preceding claims, wherein the method uses a graph-based real-time digitization and contextualization engine.

11. 10. A method according to any one of the preceding claims, wherein the plurality of data sources having heterogeneous data formats accessed by the VDIS includes at least one data source, the data of which is automatically reconciled at the time of data collection.

12. The method of claim 11 , wherein the at least one data source automatically harmonizes its data by restricting data entry to a number of predetermined fields and / or values.

13. 10. The method of claim 1, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface comprising one or more linked blocks, each block representing a step in a particular experimental and / or manufacturing process, data for which is contained in at least one of the plurality of data sources accessed by the VDIS, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS.

14. 10. The method of any one of the preceding claims, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface comprising one or more linked blocks, each block representing a unit operation in a particular experimental and / or manufacturing process, the data for which is contained in at least one of the plurality of data sources accessed by the VDIS, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the unit operation represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS.

15. 10. The method of claim 9, wherein step (c) comprises graphically rendering the response to the query via a graphical user interface comprising a plurality of tiles, each tile representing a particular subject, data for which is contained in at least one of the plurality of data sources accessed by the VDIS, and wherein one or more of the tiles are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data relating to the subject represented by the particular tile, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS.

16. 10. A method according to any one of the preceding claims, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface.

17. 1. A method of using company data in pharmaceutical product development and / or manufacturing, said method comprising: (a) receiving, by a processor of a computing device, a user query via a portal, the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product; (ii) operating a manufacturing process for producing the pharmaceutical product; and (iii) modeling a manufacturing process for producing the pharmaceutical product; (b) communicating the user query to a database management system to generate a response to the user query, the database management system accessing a plurality of data sources to retrieve results, the response to the user query including the results; (c) graphically rendering the response to the user query; The method, wherein the plurality of data sources accessed by the database management system includes at least one data source, the data of which is automatically harmonized at the time of data collection by restricting data entry to a plurality of predetermined fields and / or values.

18. 18. The method of claim 17, wherein the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data, (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

19. 19. The method of claim 17 or 18, wherein step (c) comprises updating a process monitoring graphical display with the response to the user query in real time.

20. The method of any one of claims 17 to 19, wherein the plurality of data sources accessed by the database management system comprises live data.

21. 21. The method of any one of claims 17 to 20, wherein step (c) comprises graphically rendering a digital page comprising a plurality of sentences and / or paragraphs of text, said digital page also comprising user interactive data associated with said text, said data being updated to reflect said response to said user query.

22. The method according to any one of claims 17 to 21, wherein the method uses a graph-based real-time digitisation and contextualisation engine.

23. 23. The method of any one of claims 17 to 22, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface comprising one or more linked blocks, each block representing a step in a particular experimental and / or manufacturing process, data for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data relating to the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

24. 24. The method of any one of claims 17 to 23, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface comprising one or more linked blocks, each block representing a unit operation in a particular experimental and / or manufacturing process, the data for which is contained in at least one of the plurality of data sources accessed by the database management system, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the unit operation represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

25. 25. The method of any one of claims 17 to 24, wherein step (c) comprises graphically rendering the response to the query via a graphical user interface comprising a plurality of tiles, each tile representing a particular subject, data for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein one or more of the tiles are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data relating to the subject represented by the particular tile, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

26. The method of any one of claims 17 to 25, wherein step (c) comprises graphically rendering the response to the user query via a graphical user interface.

27. 1. A system for using heterogeneous, structured data of an enterprise in pharmaceutical product development and / or manufacturing, said system comprising: a processor of a computing device; and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receiving a user query via a portal, the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product; (ii) operating a manufacturing process for producing the pharmaceutical product; and (iii) modeling a manufacturing process for producing the pharmaceutical product; (b) communicating the user query to a mediator of a view-based data integration system (VDIS) to generate a response to the user query, the VDIS accessing multiple data sources having heterogeneous data formats to retrieve integrated results, and the response to the user query including the integrated results; (c) graphically rendering the response to the user query.

28. 28. The system of claim 27, wherein the multiple data sources accessed by the VDIS include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data, (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

29. 29. The system of claim 27 or 28, wherein the instructions, when executed by the processor, cause the processor to update a process monitoring a graphical display with the responses to the user queries in real time.

30. The system of any one of claims 27 to 29, wherein the plurality of data sources accessed by the VDIS includes live data.

31. 31. The system of any one of claims 27 to 30, wherein the instructions, when executed by the processor, cause the processor to graphically render a digital page comprising a plurality of sentences and / or paragraphs of text, the digital page also comprising user interactive data associated with the text, the data being updated to reflect the response to the user query.

32. The system of any one of claims 27 to 31, wherein the view-based data integration system includes a both-as-view (BAV) (also known as global and local as view (GLAV)) backend infrastructure.

33. The system of any one of claims 27 to 32, wherein the view-based data integration system comprises a global-as-view (GAV) backend infrastructure and / or a local-as-view (LAV) backend infrastructure.

34. 34. The system of claim 27, wherein the mediator converts the user query into a plurality of source-specific queries, sends the source-specific queries to one or more wrappers for execution, and generates the response to the query.

35. The system of any one of claims 32 to 34, wherein the backend infrastructure includes multiple sources containing heterogeneous structured data that are integrated into a unified view.

36. The system of any one of claims 27 to 35, wherein the system uses a graph-based real-time digitization and contextualization engine.

37. 37. The system of claim 27, wherein the plurality of data sources having heterogeneous data formats accessed by the VDIS includes at least one data source, the data of which is automatically reconciled at the time of data collection.

38. 38. The system of claim 37, wherein the at least one data source automatically harmonizes its data by restricting data entry to a number of predetermined fields and / or values.

39. 39. The system of claim 27, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface including one or more linked blocks, each block representing a step in a particular experimental and / or manufacturing process, data for which is contained in at least one of the plurality of data sources accessed by the VDIS, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS.

40. 40. The system of any one of claims 27-39, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface including one or more linked blocks, each block representing a unit operation in a particular experimental and / or manufacturing process, the data for which is included in at least one of the plurality of data sources accessed by the VDIS, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the unit operation represented by the particular block, the additional data being included in at least one of the plurality of data sources accessed by the VDIS.

41. 41. The system of claim 27, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the query via a graphical user interface including a plurality of tiles, each tile representing a particular subject, data for which is contained in at least one of the plurality of data sources accessed by the VDIS, and wherein one or more of the tiles are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying to the user additional data regarding the subject represented by the particular tile, the additional data being contained in at least one of the plurality of data sources accessed by the VDIS.

42. 42. The system of any one of claims 27 to 41, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface.

43. 1. A system for using company data in pharmaceutical product development and / or manufacturing, said system comprising: a processor of a computing device; and a memory storing instructions that, when executed by the processor, cause the processor to: (a) receiving a user query via a portal, the query relating to one or more of the following: (i) designing a manufacturing process for producing the pharmaceutical product; (ii) operating a manufacturing process for producing the pharmaceutical product; and (iii) modeling a manufacturing process for producing the pharmaceutical product; (b) communicating the user query to a database management system to generate a response to the user query, the database management system accessing a plurality of data sources to retrieve results, the response to the user query including the results; (c) graphically rendering the response to the user query; The system, wherein the plurality of data sources accessed by the database management system includes at least one data source, the data of which is automatically harmonized at the time of data collection by restricting data entry to a plurality of predetermined fields and / or values.

44. 44. The method of claim 43, wherein the multiple data sources accessed by the database management system include one or more of the following: (i) raw exploratory oncology and / or cell therapy data, (ii) processed exploratory oncology and / or cell therapy data, (iii) cell therapy product characteristics, (iv) raw pharmacokinetic data, (v) raw primary and / or secondary biological endpoint data, (vi) manufacturing process protocols, (vii) manufacturing unit operation (device) data, and (viii) analytical device data.

45. 45. A system according to claim 43 or 44, wherein the instructions, when executed by the processor, cause the processor to update a process monitoring a graphical display with the responses to the user queries in real time.

46. The system of any one of claims 43 to 45, wherein the plurality of data sources accessed by the database management system includes live data.

47. 47. The system of any one of claims 43 to 46, wherein the instructions, when executed by the processor, cause the processor to graphically render a digital page comprising a plurality of sentences and / or paragraphs of text, the digital page also comprising user interactive data associated with the text, the data being updated to reflect the response to the user query.

48. The system of any one of claims 43 to 47, wherein the system uses a graph-based real-time digitization and contextualization engine.

49. 49. The system of claim 43, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface including one or more linked blocks, each block representing a step in a particular experimental and / or manufacturing process, data for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein the one or more blocks are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying additional data to the user regarding the process step represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

50. 50. The system of any one of claims 43-49, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface including one or more linked blocks, each block representing a unit operation in a particular experimental and / or manufacturing process, the data for which is contained in at least one of the plurality of data sources accessed by the database management system, the one or more blocks being linkable together in the creation of a new experimental and / or manufacturing process comprising the plurality of unit operations represented by the linked blocks, and the one or more blocks being dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying additional data to the user regarding the unit operation represented by the particular block, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

51. 51. The system of any one of claims 43 to 50, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the query via a graphical user interface including a plurality of tiles, each tile representing a particular subject, data for which is contained in at least one of the plurality of data sources accessed by the database management system, and wherein one or more of the tiles are dynamic such that upon user interaction with a particular block, a pop-up window is displayed conveying additional data to the user regarding the subject represented by the particular tile, the additional data being contained in at least one of the plurality of data sources accessed by the database management system.

52. 52. The system of any one of claims 43 to 51, wherein the instructions, when executed by the processor, cause the processor to graphically render the response to the user query via a graphical user interface.

53. 1. A method for facilitating user management of a manufacturing process for producing a pharmaceutical product via an interactive manufacturing management graphical user interface (GUI), the method comprising: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a plurality of unit operations in a particular manufacturing process, said data representing (i) actions performed in said plurality of unit operations and / or (ii) information collected about said plurality of unit operations; (b) causing the processor to render, via the manufacturing management GUI, a graph-based visualization of the particular manufacturing process, the graph-based visualization including a plurality of interactive nodes, each interactive node of the plurality of interactive nodes representing (i) an individual data point corresponding to a particular action performed in one of the plurality of unit operations, and / or (ii) a particular set of information collected for a particular one of the plurality of unit operations.

54. 54. The method of claim 53, wherein the graph-based visualization includes a timeline showing days and / or unit operations, and wherein each interactive node of the plurality of interactive nodes is visually associated with a particular one of the days and / or unit operations in the timeline.

55. 55. The method of claim 53 or 54, wherein the graph-based visualization includes a base graph corresponding to and representing a baseline version of the manufacturing process, together with one or more auxiliary sub-graphs, each sub-graph corresponding to and representing an experimental condition and / or variation of the baseline version of the manufacturing process.

56. 56. The method of any one of claims 53 to 55, wherein the plurality of interactive nodes are dynamic, such that upon user interaction with a particular interactive node, a pop-up window is displayed conveying additional data to the user regarding the data point represented by the particular interactive node.

57. 57. The method of any one of claims 54 to 56, comprising rendering a plurality of data point indicators for each of one or more data parameters and / or variables controlled and / or monitored during the particular manufacturing process, each data point indicator representing a collected and / or entered value of the data parameter and / or variable at a particular timepoint and / or unit operation during the particular manufacturing process.

58. 58. The method of claim 57, wherein the plurality of data point indicators are color coded according to whether data has been collected, is missing, and / or is selected for further analysis.

59. receiving, by the processor, via the GUI, a user selection of at least some of the data points; and generating, by the processor, an interactive graph plotting the values ​​of the selected data points.

60. 60. The method of claim 59, wherein the manufacturing process data includes multiple sets of values ​​for the one or more data parameters and / or variables controlled and / or monitored during the particular manufacturing process, each set of values ​​being associated with a separate lot and / or batch, and the interactive graph includes multiple traces, each trace corresponding to and showing the progression of a set of values ​​for the particular lot and / or batch with which the set is associated.

61. receiving and / or accessing, by the processor, additional manufacturing process data corresponding to one or more additional manufacturing processes; 61. The method of any one of claims 53-60, comprising: causing the processor to render one or more additional graph-based visualizations, each representing a particular one of the one or more additional manufacturing processes within the manufacturing management GUI, wherein the one or more additional graph-based visualizations align and / or overlay with the graph-based visualization corresponding to the particular manufacturing process.

62. 62. The method of claim 61 , wherein rendering the one or more additional graph-based visualizations comprises automatically highlighting deviations between the one or more processes and / or deviations from a baseline.

63. 63. The method of claim 61 or 62, comprising generating and outputting harmonized data sets corresponding to the particular manufacturing process and the one or more additional manufacturing processes.

64. receiving, by the processor, via the manufacturing management GUI, a user selection of one or more nodes for inclusion in a harmonized data set and / or user data input for one or more nodes of the graph-based visualization and / or one or more additional graph-based visualizations; and generating, by said processor, a harmonized data set based at least in part on said user selections and / or data inputs.

65. 1. A method for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, comprising: (a) receiving and / or accessing, by a processor of a computing device, manufacturing process data corresponding to a particular manufacturing process and representing operations performed and / or information collected during said particular manufacturing process; (b) causing the processor to graphically render one or more interactive panels representing the operations during the manufacturing process and / or information collected during the manufacturing process, the one or more interactive panels including one or more of the following: (i) a real-time data display panel containing a graphical rendering of data acquired from and / or input to one or more connected devices used during said particular manufacturing process; (ii) a process design display panel including a graphical rendering of one or more unit operations performed during said manufacturing process; (iii) a data entry and calculation panel including a graphical rendering of multiple fields for entry of raw data and corresponding calculations; and (iv) A material preparation and data calculation panel including a plurality of input fields and / or graphical renderings of output calculations corresponding to material preparation inputs and calculations.

66. 66. The method of claim 65, wherein a unit operation includes causing a graphical rendering of the real-time data display panel according to variations in values ​​of parameters input to and / or collected from one or more interconnected devices, and dynamically updating the real-time data display panel.

67. Step (b) generating, by the processor, a graphical rendering of the process design panel, the process design panel including one or more selectable icons, each representing a particular unit operation in a manufacturing process; receiving, by the processor, a user selection of a particular unit operation for data review and / or entry via user interaction with a corresponding one of the one or more selectable icons in the process design panel; and 67. The method of claim 65 or claim 66, comprising causing the processor to update one or more of the real-time data display panel, the data entry and calculation panel, and the material preparation and data calculation panel to reflect data related to a particular unit operation.

68. 1. A system for facilitating user management of a manufacturing process for producing a pharmaceutical product via an interactive manufacturing management graphical user interface (GUI), the system comprising: a processor of a computing device; and a memory having instructions stored thereon, the instructions, when executed by the processor, causing the processor to: (a) receiving and / or accessing manufacturing process data corresponding to a plurality of unit operations in a particular manufacturing process and representing actions performed at and / or information collected about the plurality of unit operations in the particular manufacturing process; and (b) causing rendering of a graph-based visualization of the particular manufacturing process via the manufacturing management GUI, the graph-based visualization including a plurality of interactive nodes, each interactive node of the plurality of interactive nodes representing an individual data point corresponding to a particular action performed in one of the plurality of unit operations and / or a particular set of information collected for a particular one of the plurality of unit operations.

69. 1. A system for facilitating experimental process design and data collection for a manufacturing production process via an interactive GUI, comprising: a processor of a computing device; and a memory having instructions stored thereon, the instructions, when executed by the processor, causing the processor to: (a) receiving and / or accessing manufacturing process data corresponding to a particular manufacturing process and representing operations performed and / or information collected during said particular manufacturing process; (b) graphically rendering one or more interactive panels representing the operations during the manufacturing process and / or information collected during the manufacturing process, wherein the one or more interactive panels include one or more of the following: (i) a real-time data display panel containing a graphical rendering of data obtained from and / or input into one or more connected devices used during the particular manufacturing process; (ii) a process design display panel including a graphical rendering of one or more unit operations performed during said manufacturing process; (iii) a data entry and calculation panel including a graphical rendering of multiple fields for entry of raw data and corresponding calculations; and (iv) A material preparation and data calculation panel including a plurality of input fields and / or graphical renderings of output calculations corresponding to material preparation inputs and calculations.

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