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Temperature issues affect clinical trials packaging

Dan Bell, Marken’s Vice President of Quality, Compliance and Technical Affairs, discusses pharmaceutical and biological clinical trials packaging issues.

Temperature-controlled packaging is focusing more on security around seals and tamper-evident closures, along with greater use of GPS tracking and geofencing to address DSCSA concerns for drugs in transit.
Temperature-controlled packaging is focusing more on security around seals and tamper-evident closures, along with greater use of GPS tracking and geofencing to address DSCSA concerns for drugs in transit.

Packaging World:
Acquired in late 2016 by UPS, Marken provides supply chain products to the life sciences industry and clinical trials material storage and distribution. What are the key differences in packaging/packaging design between commercial and clinical trials packaging for pharmaceuticals and biologics?

Dan Bell:
Although thermo-isolating packaging for both commercial and clinical products can usually be interchanged, there are additional considerations that are particular to clinical drugs. First, long-term stability data is not fully known during drug development. This will often result in a more conservative approach when considering packaging for transportation, additional validation times, lower temperatures, higher insulation factors, and active monitoring of environmental factors.

Clinical biological samples are likely to be time-and/or-temperature sensitive. As some clinical samples may contain infectious or pathological agents, a special consideration for packaging that meets the requirements of UN classification and Intl. Air Transport Assn.-compliant systems are more likely to be a requirement.

With commercial quantities of product, would distribution go through a more traditional process, and in pallet load quantities?

This is often the case. Quantities of clinical drugs are nearly always transported in smaller quantities than commercial counterparts. This is usually due to availability, production schedules, and patient/subjects spread over a large geographical area for clinical trials. However, greater use of specialist depots for clinical drug distribution, and the advances in late-stage customization often results in clinical drugs transported in bulk/pallet load containers albeit less than commercial quantities. It is not unusual to see multiple active containers transported in a single shipment to a regional depot to support a Phase III clinical trial.

For clinical trials, we’re typically talking about a patient either receiving a package at a physician’s office or medical facility, or via a package sent directly to the patient’s residence, yes?

Correct, however, the last two-to-three years have seen a considerable increase in the number of trials including direct to patient (DTP), or from the patient for bio samples. In fact, most trials now include a provision for DTP even if most subjects still receive their medication at a physician’s office or pharmacy. Therapies targeted to orphan disease, or where patient mobility adds to the challenge of the trial, are good candidates for this type of service. Maintaining temperature control through the last mile to the patient’s home is often critical to ensuring medicine arrives in good condition and is safe to use. A clinical trial involving DTP may also include the need for a nurse to be present to administer the medicine, which in turn requires precise coordination of supply delivery and mobile nursing care.

How is the clinical trials process different from a few years ago—in other words, what are the current and developing trends in this area?

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