Managing the Processing Activities

This lesson will guide you through the main steps of managing the processing activities. These are:

Manage Process Order Batch Details
Report Processing Start
Print Finished Product Labels
Report Processing Completion
Manage Finished Product Disposition

Manage Processing Activities

Now that the biospecimen shipment has been received and is ready for the processing activities, we can start with managing the process order batch details. For that, you navigate to the Manage Process Order Batch Details application in the Processing Activities section.

The image is a flowchart illustrating the process of managing a treatment order, divided into six main stages: Receive Treatment Order, Manage Treatment Order, Manage Biospecimen Shipment, Manage Processing Activities, Manage Finished Product Shipment, and Confirm Receipt of Finished Product. Each stage contains specific tasks, In the image the Manage Processing Activities is highlighted:under this there are 1. Manage Process Order Batch Details 2.Report Processing Start 3.Print Finished Product Labels 4.Report Processing Completion 5.Manage Finished Product Disposition

Navigate to the process order Batches

From this screen below, we can navigate to the Manage Process Order Batches view of this particular order by clicking on the arrow pointing to the right.

The image shows a screenshot of an SAP interface. The top section displays a navigation menu with tabs labeled Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Under the Processing Activities tab, there are five options: Manage Process Order Batches, Report Processing Start, Print Finished Product / Secondary Packaging Labels, Report Processing Completion and Yield, and Manage Product Disposition. An arrow points from Manage Process Order Batches to a detailed view below. The detailed view shows the Manage Process Order Batches screen with a search bar and filtering options. It lists one processing activity with details such as COI ID (RG3Y394V4), Processing Activity (Therapy Manufacturing), Processing Plant (First CMO US), Planned Processing End Date (June 28, 2024), Planned Processing Start Date (June 20, 2024), Order Status (In Progress), Processing Status (Processing Scheduled), Therapy (Cartus), and Treatment Center (Twin Lakes General Hospital).

Edit Batch Information for all Subunits

In this view, we have the information on the processing slot (planned start and end date), the associated process order in the ERP, the batches (components and expected yield information), as well as documents and logs. On this screen, we change into the editing mode by clicking on the Edit button on the top right and enter the details-page for each line item in the materials in the process order yield section.

Screenshot of the SAP Manage Process Order Batches interface. The screen displays details for a specific process order batch with COI ID RG3Y394V4. The main sections include Processing Activities, Therapy Manufacturing details, Process Orders, and Process Order Yield. The Therapy Manufacturing section shows the processing activity, plant, order status, and planned processing start and end dates. The Process Order Yield section lists four batches of finished products with line item numbers, material codes, vendor material codes, and batch numbers. The interface includes options to edit, filter, and search within the data.

Provide Subunit Batch Data

In this view, we have to provide the information like Batch ID, Subunit Type, Subunit Qualifier and Subunit ID for all associated batches and subunits of the planned processing activities. Save changes by clicking on the Apply button on the bottom right and repeat for all batches and subunits.

Screenshot of an SAP Batch Management interface for Therapy Manufacturing. The screen shows details for Batch 80035020 with COI ID RG3Y394V4 and Order Status In Progress. The patient information is viewable, and the therapy is Cartus (TH003) at Twin Lakes General Hospital (6000000001). The General Information tab is active, displaying Material: Finished Product (80035020), Vendor Material: VM320325, Batch: Batch1, and Processed Quantity is blank. The Subunit section lists one allocated item with Line Item Number 10, Subunit Type: Cryobag, Subunit Qualifier: Cryobag ID, and Subunit ID: Subunit1. The Documents section shows no items available. The interface includes options to search, upload, invalidate, and apply changes.

Once complete, click on the save button on the bottom right to save all changes and data. With the batch information prepared, the manufacturing organization now can start the processing activities.

Navigate to The Report Processing Start App

For that, select the Report Processing Start application in the Processing Activities section of the SAP Cell and Gene Therapy Orchestration landing page. Select the correct processing activity using the COI ID of the order and clicking on the arrow pointing to the right.

Screenshot of SAP interface showing the Processing Activities section. The top part displays navigation tabs: Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Below are icons for Manage Process Order Batches, Report Processing Start, Print Finished Product / Secondary Packaging Labels, Report Processing Completion and Yield, and Manage Product Disposition. The bottom part shows the Report Processing Start screen with a table listing processing activities, including COI ID RG3Y394V4, Therapy Manufacturing, Process Order 951, Processing Plant First CMO US (CMO1), Processing Status Scheduled, Order Status In Progress, and Planned Processing Start Date June 20, 2024, 4:41:40 AM Americas, Los Angeles.

Edit The Processing Start Date And The Date of Formulation

In the next view, we can now switch to the edit mode by clicking on the Edit button on the top right and enter the actual processing start date and the date of formulation in the appropriate fields. This will automatically calculate the expiration date based on your configuration. To save the changes, we click on the Save button on the bottom right.

Screenshot of SAP Processing Activity page for Therapy Manufacturing. The page is in Draft status and shows details for COI ID: RG3Y394V4, Therapy: Cartus (TH003), Processing Plant: First CMO US (CM01), and Treatment Center: Twin Lakes General Hospital (6000000001). The Order Status is In Progress and Processing Status is Processing Scheduled. The Planned Processing Start Date is Jun 20, 2024, 4:41:40 AM Americas, Los Angeles, and the Actual Processing Start Date is Jun 18, 2024, 6:13:34 AM Americas, Los Angeles. The Date of Formulation is Jun 18, 2024, 6:13:39 AM Americas, Los Angeles. The Process Order Yield section lists 4 batches with Line Item Numbers 10, 20, 30, and 40, all for Finished Product (80035020) with Vendor Material VM320325. Each batch has a Processing Date of Jun 18, 2024, 6:13:39 AM Americas, Los Angeles, and an Expiration Date of Oct 16, 2024, 6:13:39 AM Americas, Los Angeles. The Process Order Components section for Consumed Materials shows no items available. The bottom of the page has options to Save or Discard Draft.

With the processing steps underway, we need to prepare the finished product labels and also the secondary packaging labels that will be used next. On this same page, scroll down to Process Order Components and click on Add to add the consumed material for this process order (the biospecimen samples that were received from the treatment center). This will open a new window where you can select the biospecimen material that was received.

Add Consumed Biospecimen Material

In the selection window, choose the material that will be consumed by the processing activities (in this case, we will use all cryobags that were received from the treatment center. To save, click on Confirm to save the selection.

Screenshot of the SAP Therapy Manufacturing - CMO interface. The screen is divided into two main sections. The top section shows the Process Order Yield tab with details of materials, including Line Item Number, Material, Vendor Material, Batch, Manufacturing Quantity, Batch Manufacturing Date, and Expiration Date. The bottom section shows the Consumed Materials tab, which is currently empty. A pop-up window titled Add Materials is open, displaying a list of items with checkboxes, including Biospecimen Shipment, Collection 18, Leukapheresis sample, and Cryopreserved Leukapheresis sample. Two Cryobag items are selected, showing details such as Collection Qualifier, Line Item, Batch, Expiry Date, and Consumption Status. The Confirm and Cancel buttons are at the bottom of the pop-up window.

With the processing steps now underway, we can prepare the required labels for intermediate and final drug products.

Print Finished Product And Secondary Packaging Label

Using the COI ID, we can navigate to the relevant order and then generate and print all labels that will be needed for the finished product and relevant secondary packaging for the produced subunits.

Screenshot of SAP interface showing the Processing Activities section. The user has selected Print Finished Product / Secondary Packaging Labels. Below, the Finished Product / Secondary Packaging Label screen displays details for Process Order Number RG3Y394V4. Information includes COI ID, Patient Information, Therapy, Treatment Center, Processing Activity, Processing Plant, Order Status, and Processing Status. The Items section lists two entries for Finished Product (Material 80035020) with Batch Number Batch3 and Batch4, Expiration Date Oct 16, 2024, Subunit IDs Subunit3 and Subunit4, Subunit Qualifier Cryobag ID, Document Version 1, Subunit Number 2 and 1, and Label Type Finished Product Short (FPS). Options to Generate, Reprint, and Invalidate labels are available.

Report Processing Completion And Yield

With the labels prepared, the next step will be the Report Processing Completion and Yield step which can be found in the Processing Activities section of the SAP Cell and Gene Therapy Orchestration landing page. We can use the COI ID to navigate to the relevant view where we can report on the completion of the processing activities and provide information on the yield for the associated batches. For that, we switch to the edit mode and enter the relevant data for all subunits.

The image shows a screenshot of an SAP application interface. The top section displays a navigation menu with tabs labeled Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Under the Processing Activities tab, there are five options: Manage Process Order Batches, Report Processing Start, Print Finished Product / Secondary Packaging Labels, Report Processing Completion and Yield, and Manage Product Disposition. An arrow points from Report Processing Completion and Yield to the lower section of the image, which shows detailed information about a processing activity titled Therapy Manufacturing. The details include COI ID, patient information, therapy type, treatment center, processing activity, processing plant, order status, and processing status. The bottom section also has tabs for Processing Information, Process Order Yield, Documents, and Logs.

Report Processing Completion And Yield For Subunits

Here, we confirm that the batch subunit has been produced and report on the produced quantity using the appropriate fields and adding the unit of measure. Click on the button Apply on the bottom right to save changes and repeat for all subunits.

Screenshot of an SAP Batch Management interface for Therapy Manufacturing. The batch is labeled Batch1 with COI ID RG3Y394V4 and is currently In Progress. The patient information is viewable, and the therapy is Cartus (TH003) for Twin Lakes General Hospital. The material is Finished Product (80035020) with vendor material VM320325. The processed quantity is 1 EA, with a processing date of Jun 18, 2024, and a batch expiration date of Oct 16, 2024. The subunit section lists one allocated item, a cryobag with Subunit ID Subunit1 and a quantity of 100 ML. There is a comment section with one item and a documents section with no items available. The interface includes options for searching, uploading, and invalidating documents.

Report Actual Processing End Date And Date of Formulation

Once the data has been provided for all subunits, we also enter the actual processing end date and the date of formulation. Now we can save all changes by clicking on the Save button on the bottom right.

Screenshot of SAP Processing Activity page for Therapy Manufacturing. The page is in Draft status and shows the details: Click on SAVE

Navigate to Manage Product Disposition

Now that the processing steps have been completed and the finished product has been manufactured, we need to manage its disposition. For that, we navigate to the Manage Product Disposition application in the Processing Activities section of the SAP Cell and Gene Therapy Orchestration landing page. Using the COI ID we can navigate to the correct order.

Screenshot of an SAP interface showing the Processing Activities section. The top navigation bar includes options for Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Below, there are five icons for different tasks: Manage Process Order Batches, Report Processing Start, Print Finished Product / Secondary Packaging Labels, Report Processing Completion and Yield, and Manage Product Disposition. The Manage Product Disposition task is selected, leading to a detailed view. The detailed view shows a search bar and a table with one processing activity listed. The table includes columns for COI ID, Processing Activity, Order Status, Process Order, Processing Plant, Processing Status, Therapy, and Treatment Center. The listed activity has COI ID RG3Y394V4, Therapy Manufacturing as the processing activity, an In Progress order status, process order 951, First CMO US (CM01) as the processing plant, Processing Completed as the processing status, Autologous Cell Therapy (TH003) as the therapy, and Twin Lakes General Hospital (6000000001) as the treatment center.

Navigate to Disposition Status of All Batch Items

In the next screen we switch to editing mode by clicking on the Edit button on the top right and then enter all individual batch items that have been produced.

Screenshot of SAP Processing Activity interface for Therapy Manufacturing. The screen shows details for Therapy Manufacturing (951) with COI ID: RG3Y394V4, Therapy: Autologous Cell Therapy (TH003), and Treatment Center: Twin Lakes General Hospital (6000000001). The order status is In Progress and processing status is Processing Completed. The Product Batches tab is active, displaying a table with 4 batches. Each batch has columns for Line Item Number, Material (80035020), Vendor Material (VM320325), Batch (Batch1 to Batch4), Batch Status (In Quality), Out of Specification, Disposition Quantity (0 EA), Processed Quantity (1 EA), Processing Date (Jun 18, 2024, 6:13:39 AM, Americas, Los Angeles), and Expiration Date (Oct 16, 2024, 6:13:39 AM, Americas, Los Angeles). The interface includes search and settings options.

Update The Disposition Status of All Batch Items

Here, we can update the disposition status of all individual items of the produced batches. We can select the correct disposition status and apply changes by clicking on the Apply button on the bottom right. Once this information has been provided for all items, we can save all changes by clicking on the Save button on the bottom right.

creenshot of an SAP Batch Management screen for Therapy Manufacturing. The batch is labeled Batch4 with a finished product code of 80035020. The COI ID is RG3Y394V4, and the order status is In Progress. The therapy type is Autologous Cell Therapy (TH003) and the treatment center is Twin Lakes General Hospital (6000000001). The batch status is Unrestricted use. The processing date is June 18, 2024, and the expiration date is October 16, 2024. The subunit section lists one item with a subunit type of Cryobag, subunit ID Subunit4, and a quantity of 100 ML. The disposition status is Unrestricted use, and the disposition is by authorized User.

This step requires your e-signature. With this, we now have successfully accomplished all processing activities and dispositioned the finished product for being shipped and used at the treatment center.