21 Critical Cell Therapy Supply Chain Tips

6. Consider static and dynamic seasonality conditions. This depends on where you are. For example, if the destination is a clinical site in northern Japan, it may be hard to ship materials there without a temperature excursion, and you may need a more robust seasonal shipper.

7. Qualify your payload and shipping configuration.

8. Use an appropriate data logger. Seymour cautioned, “I’ve seen people pick a logger for the wrong temperature range, so it wasn’t collecting data. Check and verify that the logger meets your needs.” Some systems send auto-reminders if data hasn’t been uploaded in a certain time period.

9. Prearrange transport and check holidays in the destination. If a cell therapy misses a flight or gets stuck in customs and sits a weekend, you’re missing 3-4 days. “Check the holidays where it’s going. If it goes to Europe but it’s a 4- or 5-day weekend, the sample won’t move. Prepare customs paperwork ahead of time [if possible]. Wheels Up clearance should be considered if needed,” she said.

Seymour took this time to remind attendees that the patient has given that sample, and they may not be able to give one again.

10. Product stability can determine the selection of a centralized single site model or a de‐centralized (multi-site) model. A centralized model may not be possible. Additionally, multiple patients’ samples at the same facility at once means extra vigilance is required. Samples must be labeled clearly, and have different shelves/compartments in the incubator.

11. Scheduling must account for the health of the patient. They may need the dose X days after a planned surgery. If manufacturing is delayed, it could be very harmful.

Single-use technology

12. Understand your suppliers’ supply chain. Talk about the polymers. If the raw materials come from the same source, it can lead to issues. Diversifying through vendors can reduce risk, but pay attention upstream to the raw materials themselves.

13. If you don’t have to customize, don't. It’s beneficial to have redundancy built in. What if your custom supplier has an interruption?

Testing and release

14. Patient identification is critical for release. Sample management can be tough. Because of the timing, the standard release periods aren’t appropriate. Some products have a conditional release while lengthy assays take time to complete. Procedures must be in place to ensure patient safety.

15. Out of spec results must have processes. How do you deal with these? It may not be a binary yes/no if the product is still safe and efficacious.

Treatment

16. Plan for close communication. Delays in manufacturing must be relayed to the clinical director and patient, particularly if surgery is involved.

17. Consider the pharmacy/clinical layout. At a large health center, the infusion site may be a mile from the pharmacy. Seymour described this as the final mini-mile. How do you transport the product across the campus? Someone may just stick it in an EPS cooler and hop on the shuttle bus. She said, “Be very prescriptive about how to handle product at the clinical site!”

18. Related to #17, offer instructions. Seymour explained, “Typically this would be part of site initiation visit/pharmacy manual. Work closely with your clinical colleagues on specifics for the clinical site. You can’t have 100 SOPs, so don’t make these very specific for each site. But controlling vibration, temperature, time when the dose is prepared and how quickly it’s administered… these are specific instructions you can provide in documentation.”

Risk management

19. Look at an orchestration platform. The information from the MES, LIMS, etc. has to feed into some centralized space, such as Vineti’s platform. “You don't need to homegrow it. There are vendors for this,” she noted. Data confidentiality must be considered as patient data is transferred. There must be proper controls or security in place.

20. Risk mapping is an iterative process. Think about where the risks are throughout the supply chain. Use Target Product Profiles/QTPP to identify critical supply chainattributes and assess their impact as the therapy scales. “Even after you’ve gone commercial, feed the information back into the risk map,” she said. There are many tools such as HAZOP and FMEA—ensure it’s orthogonal.

21. Make sure that areas of lower risk don’t become high risk down the road. People can become lax, so assess risk periodically.

As Seymour told attendees, “You could have the best cell therapy facility design in the world, but if you can’t ship the product in a safe manner, you really have a problem.”