In our most recent article, we discussed the real-world complexity of transporting gene and cell samples and therapies from clinical to manufacturing to administration site and patient on time, at the correct temperature, and in perfect condition, every time.
When planning clinical trials or therapy production and administration, therefore, it’s vital to choose a logistics partner that is up to the task, has a successful track record and can demonstrate how they achieve those results.
Logistics not only covers a lot of ground, in terms of physical delivery but also in areas of responsibility. In our e-book, Tomorrow’s Medicine: Curing One Patient at a Time, Dr. Ruediger Lomb, World Courier VP for Global Quality & Technical Compliance, explains it this way:
“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….
“Knowledge of not only GDP [Good Distribution Practices] but also cGMP [Current Good Manufacturing Practices defined by the US Food & Drug Administration] is key, as it is not only adhering to existing regulations, it is anticipating potential bottlenecks in the manufacturing and supply chain, and preparing for the unexpected. Clinical teams, therefore, should be seeking ‘quality beyond compliance’ operationally at the global level…”