Managing Biospecimen Shipments

This lesson will guide you through the main steps of managing the biospecimen shipments. These are:

Book the courier for a biospecimen shipment
Manage incoming biospecimen
Print the hang-tag label
Confirm Shipment Receipt
Manage Biospecimen Disposition

Once the treatment order has been reviewed and approved, the execution phase of the supply chain orchestration can begin. In our case, this would begin with the management of the biospecimen (the starting material that is collected in the apheresis) shipment.

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, with roles indicated by color: light blue for the Treatment Order Manager and dark blue for the Manufacturing Organization. The tasks are as follows:1.Receive Treatment Order 2.Manage Treatment Order: a)Confirm Flow Version b) Confirm Schedule c) Approve Treatment Order 3. Manage Biospecimen Shipment: a) Book Biospecimen Courier b)Manage Incoming Biospecimen c) Print Hangtag Labels d) Confirm Shipment Receipt e) Manage Biospecimen Disposition 4. Manage Processing Activities: a) Manage Process Order Batch Details b) Report Processing Start c) Print Finished Product Labels d) Report Processing Completion e)Manage Finished Product Disposition 5. Manage Finished Product Shipment: a) Allocate Batches to Shipment b) Book Finished Product Courier c) Confirm Shipment Pickup d) Confirm Receipt of Finished Product. Icons representing each stage are displayed above the corresponding tasks.

Here, the first step for the treatment order manager is to book a courier for the biospecimen shipment. For that, we navigate to the order of interest using the Manage Orders application in the Treatment Managementsection.

Navigate to the Respective Order

From this screen, we can open the detail view of this particular order by clicking on the arrow pointing to the right.

Screenshot of the SAP Treatment Management interface. The top navigation bar includes options for Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Below, there are five main options: Confirm Flow Versions, Confirm Schedules, Manage Orders, Manage Inbound Logistics, and Order Overview. The Manage Orders section is expanded, showing a search bar and various filters such as COI ID, Treatment Center, Therapy, and more. One order is listed with details including COI ID, Treatment Center, Therapy, Clinical Trial Subject Number, Country/Region, Order Status, Order Number, and Changed On date and time.

Determine the Transportation Lane for the Biospecimen Shipment

In the order overview, navigate to the. Shipments tab and select the biospecimen shipment number (in blue). In the pop-up window, select Manage Shipments to navigate to the biospecimen shipment view. Here, the first thing that needs to be done is determining the transportation lane. This is done based on configured rules by the system when you click on the Determine Transportation Lane button on the top right. This will determine which courier would be best suited for the biospecimen shipment.

Screenshot of a SAP interface showing details of a biospecimen shipment. The COI ID is RG8S72U37, and the order status is marked as Order Complete. The shipment status is Delivered. The patient information, therapy type (Autologous Cell Therapy (TH003)), and treatment center (Twin Lakes General Hospital) are displayed. The interface includes options for confirming biospecimen receipt, managing biospecimen disposition, managing incoming biospecimen, managing shipments, and printing biospecimen hangtags and labels. Additional details such as shipment ID, collection center, shipment reason, ERP order reference, purchase order number, and admin data (created and changed dates and times) are also shown.

Book The Courier For The Biospecimen Shipment

The next step would then be to book this courier. Make sure that the location data and the shipment dates are correct or adjust accordingly, before clicking on the Book Courier button on the top right. This action will also generate the waybill number and populate the respective field on the Logistics tab of the biospecimen shipment. Additional information, like the Shipper Tracking Link, the Shipper Serial Number or the Temperature Monitor Serial Number can be also provided by the courier and would be available here, too.

Screenshot of SAP Biospecimen Shipment 227 interface. The screen shows details of a biospecimen shipment, including COI ID: RGBS72UJ7, patient information, therapy type, and treatment center. The shipment status is marked as Delivered and the order status as Order Complete. The interface includes tabs for General Information, Location, Shipment Dates, Logistics, Shipment and Receipt, Biospecimen Materials, Approval Details, PPF Events, Cancellation Request Details, Documents, ERP Data, and Logs. The Location tab displays the From Location and To Location details, including addresses, contact persons, and other relevant information. The Logistics tab shows logistics details, including courier ID, contact person, transportation lane, account number, and waybill details with shipper serial number, temperature monitor serial number, and shipper tracking link. The interface also includes options to edit, create tasks, determine transportation lane, book courier, and request shipment cancellation.

Using The Manage Inbound Logistics App

As an alternative, you can now also use the new Manage Inbound Logistics app to quickly navigate to and manage a biospecimen shipment.

Screenshot of a software interface for managing biospecimen shipments. The top section shows a navigation bar with tabs for Treatment Management, Biospecimen Shipment Processing, Processing Activities, Finished Product Processing, and COI/COC. Below the navigation bar, the Treatment Management section displays options for Confirm Flow Versions, Confirm Schedules, Manage Orders, Manage Inbound Logistics, and Order Overview. The middle section highlights the Manage Inbound Logistics option, showing a list of biospecimen shipments with details like COI ID, Shipment ID, Reference Shipment ID, Shipment Status, and Changed By. The bottom section zooms in on a specific biospecimen shipment (ID: 227) with detailed information, including COI ID, Patient Information, Therapy, Treatment Center, Order Status, Shipment Status, and various tabs for General Information, Location, Shipment Dates, Logistics, Shipment and Receipt, and Biospecimen.

Manage Incoming Biospecimen

Once the biospecimen is on its way to the processing site (which can be inhouse-manufacturing or a CMO), the next steps can be managed using the applications in the Biospecimen Shipment Processing section. Here, the first app that we are going to use is: Manage Incoming Biospecimen.

Screenshot of SAP Biospecimen Shipment Processing interface. The top navigation bar includes tabs for Treatment Management, Biospecimen Shipment Processing, Processing Activities, and Finished Product Processing. Below, there are four main options: Manage Incoming Biospecimen, Print Biospecimen Hangtag Labels, Confirm Biospecimen Receipt, and Manage Biospecimen Disposition. The highlighted section shows details for Biospecimen Shipment 227, including COI ID RG8S72U37, patient information, therapy Cartus (TH003), and treatment center Twin Lakes General Hospital. The order status is complete, and the shipment status is delivered. Additional tabs include Logistics, Purchase Order, Biospecimen Materials, Shipment Dates, Documents, and Logs.

Using the chain of identity (COI) ID or the Biospecimen Shipment ID, the manufacturing organization can navigate to the incoming biospecimen shipments and review all available data, i.e. the logistics information, the associated purchase order of the integrated ERP, the biospecimen batches that are part of the shipment, attached documents and logs. Also, in the Documents section an Inbound Logistics Form summarizing all shipment information can be generated and printed. This will help to prepare to receive the shipments.

Print Biospecimen Hangtag Label

One such preparation step is the printing of hangtag labels for the biospecimen. To print the hangtag label, navigate to the Print Biospecimen Hangtag Label app in the Biospecimen Shipment Processing section. Here you can use the COI ID and the Shipment ID to open the label printing view of the relevant shipment. In this view, you can select the relevant label document and generate, reprint or invalidate the associated label. The information for the label will be provided by SAP Cell and Gene Therapy Orchestration, the printing itself is then executed using the integrated label printing service.

Screenshot of the SAP system interface showing the Biospecimen Shipment Processing section. The user has selected the Print Biospecimen Hangtag Labels option. The screen displays details for Collection ID 91, including COI ID RGS72U37, Biospecimen Shipment 227, and other related information such as patient information, therapy, treatment center, and shipment status. The Label Documents tab is active, listing one label document for Cryopreserved Leukapheresis with batch number 1074 and subunit ID BSSUSE2023010609. The interface includes search and filter options, as well as buttons for generating, reprinting, and invalidating labels.

Once all labels that will be needed are printed, the next logical step will be the confirmation of the biospecimen receipt.

Confirm Biospecimen Receipt

To confirm the receipt of the biospecimen, navigate to the Confirm Biospecimen Receipt app in the Biospecimen Shipment Processing section. Here you can use the COI ID and the Shipment ID to open the confirm biospecimen receipt view of the relevant shipment. In this view, you need to go to Edit mode by clicking on the Edit button on the top right and then navigate to the collection details that are part of this shipment.

The image shows a screenshot of the SAP software interface for managing biospecimen shipment processing. The top section of the interface has a navigation bar with tabs labeled Treatment Management, Biospecimen Shipment Processing, Processing Activities, and Finished Product Processing. Under the Biospecimen Shipment Processing tab, there are four options: Manage Incoming Biospecimen, Print Biospecimen Hangtag Labels, Confirm Biospecimen Receipt, and Manage Biospecimen Disposition. A blue arrow points from the Confirm Biospecimen Receipt option to a detailed view of the Confirm Biospecimen Receipt screen. This screen shows information about a specific biospecimen shipment with COI ID: RG4D8NRU7 and Biospecimen Shipment: 251. The shipment details include the plant, pickup location, delivery location, order status, and shipment status. Additional sections provide logistics details, biospecimen materials, shipment dates, receipt confirmation, documents, and logs. The courier details list the courier as Marken and the courier contact as John Doe. The biospecimen materials section lists one item: Cryopreserved Leukapheresis with an expected quantity of 1 EA.

Confirm Subunit Receipt of The Biospecimen

In the collection details you can now confirm the receipt of all individual subunits by setting the tick mark and then applying the changes by clicking on the "apply" button on the bottom right.

Screenshot of an SAP interface displaying details of a biospecimen shipment. The top section shows the shipment number (251) and batch number (1083) from Twin Lakes General Hospital. The General Information tab includes details such as material (Cryopreserved Leukapheresis), vendor material, packaging product type (Evo DV10 Liquid Nitrogen Dry Vapor Smart Shipper), expected and received quantity (1 EA), processing date (Aug 15, 2023), and received status (checked). The Collection tab provides collection details including qualifier ID (CQI123), value (cval45), date (Aug 14, 2023), quantity (2 EA), cryopreservation date (Aug 15, 2023), creation date (Sep 9, 2023), and change date (Oct 9, 2023). The Subunit tab lists one item: a cryobag with subunit ID SUEDM771121, quantity (1 EA), and received status (checked). The Documents tab shows no items available.

Confirm Receipt Date And Condition of The Biospecimen

This will bring you back to the shipment view where you now need to confirm the date and time of the biospecimen receipt and the shipping conditions as well as the fact that the biospecimen shipment patient data matches the biospecimen and the hangtag data (COI Confirmation).To finalize this step, you now need to save by clicking on the save button on the bottom right. Here, again, your e-signature will be needed to complete this step.

Screenshot of the SAP Biospecimen Shipment interface. The page is titled Biospecimen Shipment: 251 and is in draft status. The interface has several tabs: Logistics, Biospecimen Materials, Shipment Dates, Receipt Confirmation, Documents, and Logs. The Shipment Dates tab is active, displaying planned and actual shipment dates and times for pickup and delivery. Planned Pickup Date is June 18, 2024, 10:30:24 PM in New York, and Planned Delivery Date is June 19, 2024, 7:30:32 AM in Los Angeles. Actual Pickup Date is not filled, but the Actual Delivery Date is June 18, 2024, 7:39:27 AM. The Receipt Confirmation section asks if shipping conditions are within acceptable parameters, with Yes selected. The COI Confirmation section asks if patient attributes on the cryobag match the biospecimen data form and labels, with Yes selected. The bottom of the page has Save and Discard Draft buttons.

Manage Biospecimen Disposition

Next, to manage the disposition of the biospecimen, navigate to theManage Biospecimen Disposition app in the Biospecimen Shipment Processingsection. Here you can use the COI ID and the Shipment ID to open the manage biospecimen disposition view of the relevant shipment.

Screenshot of SAP system interface showing two sections. The top section is the main menu with tabs for Treatment Management, Biospecimen Shipment Processing, Processing Activities, and Finished Product Processing. Under the Biospecimen Shipment Processing tab, there are four options: Manage Incoming Biospecimen, Print Biospecimen Hangtag Labels, Confirm Biospecimen Receipt, and Manage Biospecimen Disposition. The bottom section shows details of a specific biospecimen shipment (Shipment: 251) with information such as COI ID, Patient Information, Therapy, Treatment Center, Plant, Delivery Location, Pickup Location, and Shipment Status. The Materials section lists one item: Cryopreserved Leukapheresis with details on packaging, received quantity, disposition quantity, processing date, expiration date, and batch status.

In this view, you need to go to Edit mode by clicking on the Edit button on the top right and then navigate to the received collection details that are part of this shipment.

Update Biospecimen Disposition Status

We can select the correct disposition status for each subunit and apply changes by clicking on the Apply button on the bottom right. This will bring you back to the manage biospecimen disposition view of the relevant shipment where you can now save the changes by clicking on the save button on the bottom right. This step will again require your e-signature.

Screenshot of an SAP Material Management interface displaying detailed information about a biospecimen shipment. The interface includes tabs for General Information, Collection, Subunit, Comment, and Documents and apply.

With this, we now have successfully received the biospecimen shipment, printed relevant hangtag labels for it and dispositioned it so that it is ready for the processing activities.