Patient safety is the priority of every clinical trial. It is vital that the investigational medicine dispensed to the patient is in perfect condition, whatever the storage and distribution challenges.
Many biologics have stringent stability protocols dictating the acceptable storage temperature range to ensure the drug remains safe and effective. As such, it is critical that trial sponsors consider many factors to control drug temperature conditions throughout the supply chain.
From point of manufacture to delivery to the patient, the drug will be exposed to a multitude of environments during its many stops in the supply chain - such as transit to packaging site, packaging and labelling, shipment to storage facility, storage, shipment to depot, shipment to final destination and storage at investigational site.
Traditional USB temperature monitors enable sponsors to identify any excursions that may occur during shipment. These monitors prove especially useful once in storage at clinical centres or research hospitals; site staff can keep monitors with investigational medicines and frequently check for any temperature excursions.
When thinking of more sophisticated, real-time data collection monitors, the real question is what strategies can we use if an excursion is about to happen? In many instances, the potential benefit is insufficient to justify the expense; there may not be enough time or resources to mitigate the excursion before it happens.
The technology of real-time temperature monitoring - while impressive - will not prevent an excursion from happening, but can be beneficial if there are protocols mitigating the consequences of an in-transit excursion. Once a problem is detected, the options are limited depending on where the shipment is located. Either a fresh shipment can be issued to replace the suspect product, or it can be rerouted back to the origin. However, the latter option may not be enough to save the shipment, often invaluable IMP with limited availability.
To ensure reliable shipments, PCI Clinical Services has enabled a higher standard for shipper qualifications, testing shipper performance against extreme temperature conditions that are much more intense than the industry standard requirements. Once a shipment leaves the origin, the shipper will face an array of environmental conditions depending on weather and various global geographies. For example, a winter profile will account for extreme low temperatures on the tarmac, as well as above average hot temperatures at the destination location that may be nearer the equator. A second profile for summer would account for a short period of mild environmental temperature when in flight and even higher temperatures throughout ground transit.
The shipper is chosen based on the weather forecast on the day of dispatch, and has a packaging configuration and cooling method to keep the drug on temperature, whether it be a water-based gel, phase change or dry ice. The chosen configuration will mitigate any environmental risk posed to the investigational product inside.
When considering clinical trials in geographies with limited storage facilities, a common occurrence in Europe (where hospitals in urban areas are older and have tight quarters), it is important to consider package design. The growing popularity of kitting may cause the investigator difficulty once on-site, where storage space - especially refrigerated storage - is scarce. The kit may add additional, unnecessary bulk if there are items that do not require temperature control or monitoring.
At PCI, the ideal direction is to care for cold chain products in a specific temperature-controlled environment and handle ancillary items separately to optimally use valuable and limited cold storage. For example, adding syringes and needles to a kit may look nice and add convenience, but kitting them together is not recommended where storage facilities are in high demand. This will also save the sponsor the cost of cold chain storage and distribution for items not requiring those conditions.
Keeping biologics safe and effective is the highest priority. It is important to consider traditional and nontraditional methods to mitigate every possible risk to the product and patient.