Identifying the Benefits, Capabilities, Components, and Processes of SAP Cell and Gene Therapy Orchestration

Objectives

After completing this lesson, you will be able to:

  • Describe the high-level process of delivering a typical cell therapy and the unique supply chain of Cell and Gene Therapy operations
  • Outline the main benefits that are achieved by SAP Cell and Gene Therapy Orchestration
  • Explain which processes in the supply chain of typical cell therapy are supported by SAP Cell and Gene Therapy Orchestration
  • Identify the core and cross components of SAP Cell and Gene Therapy Orchestration
  • Describe the main capabilities of SAP Cell and Gene Therapy Orchestration solution

Introduction and High Level Processes

As an introduction to the SAP Cell and Gene Therapy Orchestration solution, we invite you to view this short video.

Note
This lesson will outline the unique supply chain processes that are needed for a biotech company to implement a typical clinical or commercial cell therapy program. You will learn which capabilities are provided by the software-as-a-service solution SAP Cell and Gene Therapy Orchestration to address these needs and which benefits can be expected. You will discover which cross components and core components are provided by SAP Cell and Gene Therapy Orchestration to orchestrate these processes and ensure that the right product is delivered to the right patient at the right time.

In the last 5-10 years, cell and gene therapies (often also called advanced therapy medicinal products (ATMPs)) have emerged as a promising new therapeutic modality. They offer unique clinical and therapeutic advantages over conventional small molecules and biologics. Specifically, living cells can perform complex biological functions in ways that conventional drugs cannot, thus expanding the spectrum of available therapeutic options to include key cellular functions and processes. As such, cell and gene therapies are currently one of the most investigated therapeutic modalities, with several products having been approved and more than 2000 active clinical trials ongoing (figure above adopted from the Alliance for Regenerative Medicine H12022 report with permission).

New cell and gene therapy (CGT) products will surely emerge from this pipeline, requiring new business capabilities to provide adequate access during the commercialization phase.

To clarify why new business capabilities are required and what they are, let us first review the typical high-level process of delivering an autologous cell therapy. Here, autologous means that the patient's own cells are used as the drug after having been modified to elicit the desired clinical effect.

Briefly, the major steps in the manufacture of a relatively complex cell therapy are as follows:

  1. First, an eligible patient is identified and the appropriate therapy is selected and ordered at the vendor
  2. Blood or cells are extracted from the patient (apheresis or biospecimen collection)
  3. The cells are prepared for further processing or shipments (for example, cryopreservation)
  4. The cells are shipped to the site of manufacture, which could also be done by a third-party, that is, a contract manufacturing organization (CMO)
  5. At the site of manufacture, relevant cell populations are isolated, the cells are activated, genetically modified, and expanded before undergoing post-processing, such as washing and purification
  6. After samples are taken for quality assurance (QA) measures, the cells are concentrated and packaged by dose before being shipped to the treatment site
  7. At the treatment site, the product is prepared for infusion and the therapy will be administered
  8. Lastly, the billing and reimbursement steps complete the process

This process is very different to traditional small-molecules or biologicals pharmaceutical manufacturing and involves tight interaction between the cell therapy vendor and numerous external stakeholders. The supply chain is much more complex and requires the ability to follow the patient journey as well as the product journey and ensure that the right product is delivered to the right patient at the right time without errors.

To orchestrate the supply chain and provide this visibility and control, we developed SAP Cell and Gene Therapy Orchestration which supports the process with the following capabilities:

  • Order Management
  • Biospecimen Shipment
  • Processing Activities
  • Finished Product Shipment
  • Chain of Identity and Chain of Custody Management and Reporting

With these capabilities, SAP Cell and Gene Therapy Orchestration is positioned between the clinical side and the complex supply chain side. Its role is to facilitate, manage, and drive the cell and gene therapy supply chain. It is the hyper-connected conduit between all functions in the supply chain, helping the CGT case manager and related roles to ensure patient orders are fulfilled on time with zero errors.

Benefits

We see clear benefits that are provided by employing SAP Cell and Gene Therapy Orchestration:

  • End-to-end supply chain visibility and orchestration in line with regulatory compliance
  • Establish and maintain the chain of identity and chain of custody
  • Orchestrate the delivery of finished product to the right patient at the right time with zero errors
  • Being compliant with regulatory requirements and reducing compliance costs
  • Reducing cost and turn-around time
  • Increase efficiency by orchestrating the cell or gene therapy supply chain
  • Accelerate setup and rollout of new therapies or products
  • Integrate with all relevant business partners, such as treatment center, cell labs, contract manufacturing organizations (CMOs), and logistics service providers
  • Faster time to market for cell and gene therapies
  • Reduce manual effort to onboard new treatment centers
  • Achieve your clinical trial recruitment goal faster by working with more sites
  • Be ready to scale your cell or gene therapy supply chain for commercial phase

Process Overview

Thus, the process begins with receiving the treatment order from the treatment center where the patient has been identified and found to be eligible for this therapy. The treatment order manager then needs to determine the exact supply chain for this order, confirm the schedule for it, and book the courier for the biospecimen shipment from the treatment center to the manufacturing facility.

The manufacturing organization then takes over to manage the incoming biospecimen. Here, the hangtag label that will be used need to be printed to be ready to be applied. Once the biospecimen shipment has arrived, the receipt is confirmed and the biospecimen is dispositioned before the processing activities are started.

The actual manufacturing begins by managing the process order batch details and reporting the processing start. While the manufacturing steps are ongoing, the labels for the finished products are printed. Once processing is completed, this is again reported before the finished product is dispositioned and prepared for the shipment.

The manufacturing organization allocates batches of the finished product to the shipment and the treatment order manager books the courier for the finished product shipment accordingly to the schedule. The last step that the manufacturing organization needs to do is to confirm the finished product pickup once the courier picked up the shipment.

The successful receipt of the finished product shipment is then confirmed by the treatment center before the product is used.

Setting up a typical autologous cell therapy program requires new processes that differ a lot from the traditional "make to stock" manufacturing in the life science industry for small-molecules or biologicals drugs. Autologous cell therapies are personalized products that require the patient's own cells as input for the manufacturing process.

Setting up a typical autologous cell therapy program requires new processes that differ a lot from the traditional "make to stock" manufacturing in the life science industry for small-molecules or biologicals drugs. Autologous cell therapies are personalized products that require the patient's own cells as input for the manufacturing process.

Core and Cross Components Overview

SAP Cell and Gene Therapy Orchestration is composed of core and cross components with distinct capabilities to support this complex supply chain. It is the hyper-connected conduit between all functions in the supply chain, helping the CGT case manager and related roles to ensure patient orders are fulfilled on time with zero errors.

The core components are:

  • Treatment order: Used to get an overview of a single treatment order for a patient and all related data and documents. It can also be used to manage individual steps like shipments and processing activities.
  • Flow version: Used to determine the exact supply chain for a single treatment order based on location rules.
  • Goods flow: Used to manage the product journey from the biospecimen collection and shipment, through the processing activities, optional distribution center or depot steps, to the shipment of the finished product.

The cross components are:

  • Document management: Documents can be added/uploaded for later review or documentation purposes at all major steps in the process
  • Chain of identity and chain of custody: All steps of the patient and product journey are recorded to ensure that the right product is delivered to the right patient and to be able to provide a report.
  • Exception management: If deviations or delays are noticed, exceptions can be raised to assign somebody to work on a resolution
  • Task management: Can be used to assign to-do tasks to individuals to support the process
  • Supply chain partner portal: External contributors can be provided access to individual apps of SAP Cell and Gene Therapy Orchestration to manage the steps they are responsible for

Typically, SAP Cell and Gene Therapy Orchestration will be interacting with a number of external systems, mainly with the ERP system of the cell therapy manufacturer and the patient onboarding and management application on the treatment center side.

Capabilities Overview

With the core and cross components just discussed, SAP Cell and Gene Therapy Orchestration provides the following capabilities to support the supply chain of a cell or gene therapy:

  • Order Management
  • Provides Order Management with configurable orchestration of the process from biospecimen pickup until delivery of the therapy
  • Approval workflow for orders
  • Enables visibility for pick-up and delivery date reservation
  • Manufacturing
  • Provide visibility of manufacturing status
  • Supports processing, disposition, and logistics of product batches
  • Label management with an interface to existing printing solutions¬†
  • Logistics
  • Manage shipment order lifecycle (soft booking, booking, handovers, and so on)
  • Interaction with multiple Logistic Service Providers
  • Provides digital document exchanges
  • Chain of Identity and Chain of Custody
  • Generate or capture Chain of Identity and Chain of Custody IDs
  • Collect and store Chain of Identity/Chain of Custody events
  • Provide Chain of Identity/Chain of Custody reporting

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