Transporting cell and gene samples and therapies on time, at the correct temperature and in perfect condition can be a logistics challenge like no other. World Courier discusses how planning is vital to optimum performance.
Cell and gene therapy products are produced one by one, under strictly controlled conditions, using live biomaterials. Time and temperature variations can destroy them, so samples must arrive at manufacturing sites, and therapies at clinical sites, on time and in pristine condition.
In theory, that’s a tough job: in the real world, it’s much harder. Weather, air traffic, road conditions, climate zones, customs regulations and processing times can’t be allowed to delay delivery, or affect the temperature-controlled packaging of the samples and therapeutic materials.
To ensure success, study sponsors and therapy owners should start planning years in advance to develop a unique supply chain for these personalised medicines. Logistics providers aren’t just responsible for the physical delivery, as Dr Ruediger Lomb, World Courier’s vice-president for global quality and technical compliance, explains: "Acting as an extension of the shipper from pick-up through delivery, a qualified GxP-compliant logistics partner will deliver the required service basics – an uninterrupted chain-of-custody during transit according to established global SOPs. This, however, is the minimum of expectations when it comes to managing these shipments.
Quality beyond compliance
"Knowledge – not only of good distribution practices, but also of current good manufacturing practices (cGMP) as defined by FDA – is essential in order to adhere to existing regulations, as well as to anticipate potential bottlenecks in the manufacturing and supply chain, and prepare for the unexpected. Clinical teams, therefore, should be seeking ‘quality beyond compliance’ operationally at the global level."
According to Lomb, logistics firms should provide:
- a dedicated cross-functional project team able to consistently manage the intricacies of these shipments globally
- study-specific SOPs and work instructions applied globally
- mandatory pre-trial training and credentialing for all personnel globally who come in contact with the shipments: clinical staff, investigators, logistics personnel and external suppliers
- public and industry outreach to other key stakeholders, such as customs agents and airline personnel, to assure that everyone understands what is at stake
- unrelenting attention to detail from people who can and will think outside the box
- oversight and continuous assessment by company leaders.
"Compliance can be obtained by strict adherence to SOPs," he concludes, "but quality can only be obtained by engaging all major stakeholders both inside and outside the supply chain on a shipment-by-shipment basis. That role falls on the logistics provider."
While partnering with a qualified GxP-compliant logistics provider is, without doubt, the place to begin, it is far from the end when it comes to handling these highly complex high-value shipments.
To find out more about global logistics strategies for cell and gene therapies, please download World Courier’s new ebook, Tomorrow’s Medicine: Curing One Patient at a Time, from the company’s website (see below).
