By Paddy Hanlon, Senior Director, Business Development, Marken
Ultimately, it is a patient’s health that we are entrusted to protect.
Life science products have a distinct logistical profile; the nuances between a fine chemical and a medical compound or medical devices and computer hardware have significant regulatory differences. When determining the logistics plan for a product it is critical to remember that it is not just a box.
The health and lives of patients, both currently in treatment and those patients dependant on the result of a trial, will benefit from the research conducted. Every product shipped, whether Active Product ingredient (API), blood specimen, or clinical trial supply such as medicines or devices, is the result of millions of dollars worth of investment and years of research expertise. As logistics experts, life science companies and physicians turn to us to extend their reach of quality and diligence in protecting their assets and the health of their patients.
In determining the best logistics solution the three key elements to consider are:
1. Think inside the box
2. Think about the box
3. Think outside the box
Think inside the box: understanding the profile of the product.
Is it a biological, or a small molecule drug? What sensitivities does it have and what risks should be avoided through the transit chain? Understanding the product must be the first step in defining the logistics solution.
In the case of a specimen, if it is a PK sample it could represent a critical endpoint for a clinical trial. That would escalate the value of that shipment as it could impact data submitted to the FDA or other regulatory bodies. The specimen may also be safety data required to manage patient dosing. Either way, understanding the risks can only help determine the next step.
Think about the box: protecting the product on its journey.
The box, temperature logging device, and all the accessories are intended to protect the product on its journey. Matching the secondary packaging to the sensitivities and risk of a product should not be taken lightly. This step includes questions on who is packing the materials and how complex the packaging preparation needs to be to assure success. While system cost is a factor in every program, it is important to keep in mind the risks if the product doesn’t reach its destination in ideal conditions. Would it risk the trial? Will the patient need to come back for a second test? How quickly can the product be replaced, and at what cost?
The packaging system and temperature monitoring data may also be questioned by regulatory bodies to verify the quality of the product or results of a test. Once the system and accessories are identified the next factor needs to be considered.
Think outside the box: what environments will the shipment experience.
Extreme temperatures, cross hemisphere shipments, and customs concerns all play a part in this next step. Ultimately, time is also a factor in success, so having an understanding of what external barriers may either delay or impact the packaging system is crucial to extending quality and patient safety. Global regulations on the transfer and transport of biological products, live virus, or controlled substances can substantially delay delivery or cause interference in the packaging system. Also, security agencies such as the TSA may impact the program. Finally, environmental conditions vary from week to week and lane to lane; all these are critical factors that may dynamically affect the scope of a multi-shipment program.
In summary, remember:
- Packaging is only part of an overall solution
- Delivery speed — shorter the transit time provides less opportunity for excursions (know lanes, know airport capabilities and customs processing times)
- Practical Experience: ‘real world’ experience on packaging, conditioning, and when to transfer into cold storage may make the difference in the success of a program
- Understanding seasonal and geographic variations that can have an impact on packaging solutions
- Expertise on routing choices, airlines, and regional holidays is a critical factor
- Recording temperature in transit to meet regulatory requirements should be part of best practices.