Living cells mean complexity for distribution. Demanding criteria such as higher temperature sensitivity, lower margin for error and extremely tight timelines all require extra careful handling.
- starting cell material is derived from patients via apheresis.
Whole blood, stems cells or bone marrow drawn from patient
Step 1 of 6
Apheresis
Sample Collection
Patient samples must be shipped at defined temperature ranges to avoid compromising cells
The most common temperature requirements is 2°C to 8°C, but it can vary from cryogenic to controlled ambient depending on the therapy. Transport from the site (apheresis center) to production facility within 18 to 36 hours is a frequent timeline requirement and could present a challenge based on the shipping lane.
X-raying cells can also impact their viability so logistics providers must have processes in place to arrange for
hand searches or other allowable (non X-ray) checks to be performed at airports whenever possible. Leveraging a ‘known shipper’ status or being in good standing with regulators locally may help streamline the security process.
Step 2 of 6
Apheresis
TRANSPORT
Cells undergo processing and are transformed into the final drug product, which is typically stored and shipped at frozen and cryogenic temperatures. These materials are often very high value and can be irreplaceable so manufacturing and logistics providers must work closely together to ensure a tightly temperature-controlled and
precise supply chain with clear visibility for all stakeholders.
Step 3 of 6
Production
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Are adequate risk mitigation / issue escalation plans in place?
What transit milestones need to be communicated?
Are shipping lanes mapped out with suitable contingencies in place?
Will GPS tracking be required? If so, for location, temperature or both?
Who will ensure dry shippers are properly charged with liquid nitrogen?
If cryogenic temperatures are required, who will provide the dry shipper and how will scheduling be managed?
Common temperature requirements for the manufactured product are frozen and cryogenic, and packaging types include frozen/dry ice or a dry shipper. Any deviations can have a serious impact on all involved parties involved, including the patient.
Critical factors to consider across the supply chain in advance:
Product
Step 4 of 6
TRANSPORT
It is critically important that therapies are received at the administration site on time so that treatment can be administered to the patient as scheduled.
The supply chain inherently faces some level of unpredictability. Elements that impact expected transit times are amplified when strict timelines are at stake. Products are sensitive and patient treatment is urgent and scheduled.
The logistics partner has an important role to play in the site experience; both for patients and provider/physicians; collection and administration should be as convenient as possible, completed every time and performed as scheduled.
Therefore, these shipments require flawless execution that considers various supply chain challenges.
Step 5 of 6
SITE for patient administration
Repeat as necessary.
A breakdown in the supply chain, whether the logistics coordination or transportation process, could mean a missed shipment. A missed shipment could result in a missed treatment, which has the potential to impair individual patient outcomes while being costly and disruptive to
the manufacturer.
At the administration site, the cell therapy is administered to the patient.
Why World Courier
Step 6 of 6
Treatment
Why World Courier
Apheresis
Sample Collection
Apheresis
Transport
Production
Product
Transport
Site for Patient Administration
Patient
Treatment
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Autologous Cell Therapy Supply Chain
