Knowledge quiz

It's time to put what you've learned to the test, get 8 right to pass this unit.

What makes the supply chain of an autologous cell therapy so different compared to traditional small molecule drug manufacturing?

Choose the correct answer.

The manufacturing organization can only process one therapy request at a time.

As the product will be administred to the same patient, good manufacturing practice (GMP) does not apply.

The patient's own cells are the starting material for the manufacturing process and need to be shiped to the manufacturing site first.

A good cell donor needs to be identified whose cells can be used for the manufacturing process and then administred to the right patients.

What can you do with the "Monitor Business Events" application?

Choose the correct answer.

Manage chain of identity report.

Configure therapy types and categories.

Set up master data for material and organizations.

Find all business events with their respective information, view current status, and retrigger events if necessary.

Name the four main capabilities of SAP Cell and Gene Therapy Orchestration.

Choose the correct answer.

Order Management, Goods Flow, COI/COC, Reporting

Order Management, Manufacturing, Logistics, COI/COC

Patient Onboarding, Manufacturing, Logistics, COI/COC

Order Management, Processing Activities, Patient Management, COI/COC

Why have cell and gene therapy products generated so much excitement in the life science industry in the last 5-10 years?

Choose the correct answer.

They are easy to manufacture and show no adverse effects while being very effective

They can perform complex biological function and offer unique clinical and therapeutical advantages.

Patients can buy them over-the-counter and administer at home.

Most have been approved for use by the FDA and EMA and are easily accessible by patients.

Which are the four key entities used in processing a CGT order?

Choose the correct answer.

Purchase Order, Process Order, Sales Order, and Service Order

Shipper, Hang-Tag Label, Cryobag, Cell Culture

Treatment Order, Shipment, Collection, Processing Activity

Treatment Order, Process Order, Batch, Shipment

Which feature of SAP Cell and Gene Therapy Orchestration will be helpful to manage the mitigation in case a delay arises?

Choose the correct answer.

Monitoring

Logistics Management

COI/COC Management

Exception Management

Where in the CGT value chain is SAP Cell and Gene Therapy Orchestration positioned?

Choose the correct answer.

It is used by the health-care providers in the clinic to manage patient data

It is used by the logistics service provider to manage the fleet of trucks to deliver CGT products.

It is used by the quality assurance team in CGT manufacturing to release batches of finished products.

It is positioned between the clinical side and the supply chain side and is used by the CGT case manager to orchestrate the supply chain.

Which of the following configuration aspects is related to organizations and business partners?

Choose the correct answer.

Configure organization location types, configure sales area, configure plants.

Configure material types, configure material groups.

Configure therapy types, configure therapy categories, configure indications.

Configure user status, configure status profiles, configure entity status profile.

Name 4 cross-platform features available in SAP Cell and Gene Therapy Orchestration.

Choose the correct answer.

COI/COC, Document Management, Task Management, Exception Management

Master Data Management, Document Management, Monitoring, E-Signature

Authorization, E-Signature, Document Management, Audit Logging

Authorization, E-Signature, Audit Logging, Application Logging

10.

Name the three core components of SAP Cell and Gene Therapy Orchestration.

Choose the correct answer.

Treatment Order, Flow Version, and Goods Flow.

Treatment Order, Logistics, and Manufacturing.

Document Management, Goods Flow, and Treatment Order.

Treatment Management, Manufacturing, and Logistics.