Illustrating the Main Features and Capabilities of SAP Cell and Gene Therapy Orchestration​

In this chapter, we will explore the key features of SAP Cell and Gene Therapy Orchestration, including order management, task management, exception handling, manufacturing management, and shipping logistics. We will also delve into cross-platform services, master data management, and capabilities for handling patient data, document management, and label printing. Each feature is designed to optimize the orchestration of cell and gene therapy treatments, ensuring safety, efficiency, and compliance with regulatory standards.

SAP Cell and Gene Therapy Orchestration is a comprehensive solution designed to manage the complex supply chains and processes involved in personalized cell and gene therapies. This platform ensures the integrity and transparency of both the chain of identity (COI) and the chain of custody (COC) throughout the treatment lifecycle. Its key features includes:

1. Order Management
2. Core functionality that manages treatment order requests from creation to fulfillment.
3. Integrates with source systems for data validation and completeness.
4. Task Management
5. Assigns and orchestrates tasks among users.
6. Triggers notifications to ensure timely action and updates.
7. Exception Management
8. Captures and handles exceptions during order processing to ensure timely and accurate treatment delivery.
9. Chain of Identity/Chain of Custody (COI/COC) Management
10. Tracks patient-specific materials and drug products through the supply chain.
11. Generates COI/COC IDs and reports for transparency and regulatory compliance.
12. Manufacturing Management
13. Manages manufacturing processes including label printing, sample quality reporting, and product shipment.
14. Supports e-signatures for good practice (GxP) relevant steps.
15. Shipping and Logistics Management
16. Manages biospecimen and finished product shipments.
17. Coordinates logistics handovers and bookings with couriers.
18. Cross-Platform Services
19. Provides authorization, e-signature, audit logging, application logging, monitoring, and change logs.
20. Master Data Management
21. Manually creates and manages necessary master data such as Contract Manufacturing Organizations, material master, business partners, carriers, and therapies.
22. Access Patient's Protected Health Information (PHI)
23. Securely accesses patient data stored in the customer's PHI Data Vault based on authorization.
24. Document Management
25. Links, views, uploads, downloads, and prints documents related to various entities in the system.
26. Label Generation and Printing
27. Integrates with third-party systems to generate and print labels for products and shipments.

This overview provides a foundational understanding of the capabilities and benefits of SAP Cell and Gene Therapy Orchestration, setting the stage for detailed exploration of each feature in the subsequent sections.

Order management is the core of the SAP Cell and Gene Therapy Orchestration (CGTO) solution, represented primarily by the Manage Orders app. This feature orchestrates the journey of treatment order requests from their creation in patient onboarding or treatment request applications (not part of the CGTO solution) through to their submission, validation, fulfillment, and closure. The journey involves data collection and task assignments via integrated source systems such as ERP.

The integrated Process Flow app provides an overview of the order processing steps and their statuses. Additionally, the Order Overview app offers visualizations of key performance indicators for treatment orders and their processing steps, including counts, comparisons, and actual vs. target metrics. All other solution components support these overarching order management capabilities, ensuring streamlined operations, reduced manual tasks, and minimized errors, ultimately enhancing patient safety and operational efficiency.

Task Management ensures efficient assignment and orchestration of tasks among users. This feature integrates seamlessly with the Manage Orders, Manage Shipment, and Manage Processing Activity apps, displaying the number of open tasks within these interfaces. Users are directed to the Manage Tasks app to view and manage these tasks. Task Management also triggers notifications to keep users informed about task assignments and updates, ensuring that all activities are tracked and completed in a timely manner.

Exception Management is crucial for handling any issues that arise during order processing or other workflow steps. The Manage Exceptions app captures these exceptions, making them available for users to address and correct. This ensures that treatment orders can continue to be executed and managed even when exceptions occur. The app is integrated into the Manage Orders, Manage Shipment, and Manage Processing Activity apps, allowing users to view and manage open exceptions directly from these interfaces.

COI and COC management ensures the permanent, unequivocal, and transparent association of a patient's unique identifiers to their biospecimen tissue or cells (raw material), and the resulting drug product. This spans the entire process from order through manufacturing to treatment. Key functionalities include:

• Generating COI/COC IDs
• Collecting and storing COI/COC events
• Querying events
• Generating COI/COC reports

These capabilities enable comprehensive tracking of a product through the supply chain, ensuring regulatory compliance and patient safety.

SAP Cell and Gene Therapy Orchestration provides robust label-printing functionality by integrating with third-party label management systems. Users can generate and print labels directly from various apps within the solution. These labels, which may contain critical patient data, are securely stored in the document vault. This feature ensures that labels are accurately produced and managed, supporting the traceability and identification requirements crucial in cell and gene therapy processes.

Manufacturing Management allows users to view and manage all past, planned, and future processing activities. Each activity encompasses various functions such as:

• Label Printing
• Reporting the quality of received samples
• Disposition of biospecimen and finished product
• Reporting processing start and completion with yield
• Allocation of manufactured batches to shipment

All GxP relevant steps, including expiry date changes, manufacturing termination, and COI data updates, are supported by e-signature. Key functionalities include viewing order data, label printing, and capturing milestones like goods receipt, biospecimen disposition, processing milestones, and product shipment.

SAP Cell and Gene Therapy Orchestration provides robust document management capabilities, allowing users to link documents (which may or may not contain Protected Health Information (PHI) to various entities such as treatment orders, shipments, and processing activities. Users can view, download, and print existing documents from the document vault, as well as upload new documents into the vault. This functionality ensures that all relevant documentation is easily accessible and securely managed, supporting the detailed tracking and compliance requirements essential in cell and gene therapy workflows.

SAP Cell and Gene Therapy Orchestration ensures secure management of patient data by providing authorization-based access from various apps within the solution to the patient's data stored in the customer's Protected Health Information (PHI) Data Vault. This ensures that only authorized personnel can access sensitive patient information, maintaining confidentiality and compliance with data protection regulations. This feature is crucial for safeguarding patient privacy while allowing necessary access for treatment and processing activities.

The Manage Shipment app in SAP Cell and Gene Therapy Orchestration handles the logistics of shipping biospecimens (BS) and finished products (FP). This feature triggers booking requests to couriers and manages the handover process steps. By streamlining and automating these logistics processes, the Manage Shipment app ensures timely and accurate transportation of critical materials, enhancing the efficiency and reliability of the supply chain in cell and gene therapy treatments.

SAP Cell and Gene Therapy Orchestration provides several master data management apps essential for running the therapy processes. These apps facilitate the creation and management of critical master data, including:

• Contract Manufacturing Organizations (CMOs)
• Material Master Data
• Business Partners
• Couriers
• Therapies
• Flow Definitions

By maintaining accurate and comprehensive master data, the system ensures smooth and efficient operation of the entire cell and gene therapy orchestration process, supporting all other functional areas within the solution.

SAP Cell and Gene Therapy Orchestration provides several platform-wide, reusable services that enhance the overall functionality and security of the system. These services include:

• Authorization: Controls access to various parts of the system based on user roles.
• E-signature: Ensures that critical actions are authenticated and verified.
• Audit Logging: Keeps a record of all user activities for security and compliance purposes.
• Application Logging: Monitors system performance and logs application events.
• Monitoring: Tracks system health and performance.
• Change Logs: Records changes made within the system to maintain data integrity and traceability.

These services ensure robust, secure, and compliant operations across the entire platform.