Brian Keesee, executive director, US clinical services at PCI explains how to efficiently maximising the supply chain for biologics in clinical trials.
Cold Chain
Biologics such as a drug, vaccine, or an antitoxin are synthesized from living organisms or their products and used as a diagnostic, preventive, or therapeutic agent.
Supply chain requirements of a biological are similar to those of a non-biological product – with the ultimate objective of delivering the drug safely, on time, to the right location, at the right temperature and at the lowest cost.
With biological products often being more expensive than conventional drugs, and therefore of higher value, extra care must be taken ensure that all supply chain processes are robust and validated to avoid potential hazards.
Biological therapies have widely varying temperature requirements, calling for specialist Cold Chain or Ultra Low Temperature (ULT) storage, packing and distribution. Maintaining correct product temperature is paramount and a reliable, expert cold chain process is critical to product integrity.
Effective supply chain for Biological Investigation Medicinal Products (IMP) can be addressed in three key phases:
Plan ahead
In the EU, in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), an IMP for clinical trial use has to be stored and distributed from a fully licenced facility. In most clinical trials, the IMP will not be manufactured in the same country as the Qualified Person (QP) certification and will need to be imported.
A copious amount of information is needed to gain an import licence for a biological product. In the UK, the Department for Environment, Food and Rural Affairs (DEFRA) issues licences for the import of any animal- or human-derived product. Issues will occur if the product contains materials not covered under general licences, where an individual product application must be made.
At the onset of a clinical trial, it is vital to establish the information and timelines for obtaining licenses to import the IMP into all countries involved. Compiling this in advance may impact the decision to perform a trial in a specific region, and should be considered alongside the regulatory authority requirements.
When shipping biological products, selecting the correct transportation method is paramount. Most products of this type are sent by air; the quickest means of transport given the need to maintain product temperature. The selected transport system must be able to maintain the required temperature for the duration of the journey, including the flight, customs clearance and onward delivery.
Specialist couriers should be used for biologic shipments capable of ensuring that correct temperatures are maintained throughout the journey. Specialist suppliers can be costly; however, the risk of experiencing a temperature excursion can be far more costly.
Map transport routes and storage depots
When shipping to countries outside of the EU, several factors may require an in-country depot to be used – including import license requirements and transportation time. Additionally, for some trials the time between patients being screened to receiving their first dose can be short – customs processes may make it impossible to meet these timelines, so local storage depots are essential.
The supply route should be considered on both an individual product and country basis. The product, cost and availability as well as site storage capacity and recruitment rates must be addressed to ensure a secure and cost-effective route that meets trial demands.
Cold chain packaging for trial material logistics
Selection and preparation of shippers is critical for temperature-controlled products. Shippers must be qualified to last the duration of the shipment and couriers should have the facilities to top up, dry ice or hold refrigerated product.
Even with qualified shippers, a monitor must be included to ensure product temperature, ideally one allowing immediate review of the data. While high quality shippers and monitors may add cost, using them reduces the risk of temperature excursions.
These three phases look at product supply chain where final packaging is already defined. Greater efficiencies could be made if an integrated design process is introduced in conjunction with the supply chain.
An integrated process where supply chain is considered at design or proposal stage enables the development of a streamlined and efficient strategy for each trial, capable of delivering product on time, at temperature and cost-effectively.
Selecting an experienced service provider early in the study development phase avoids frustrations common to shipping Cold and Ultra-Cold Chain products, ensuring the focus remains on the successful delivery of life-saving therapies.