You're shipping critical biological materials: do you take your chances, or do you perform a full shipper qualification and transit lane study? To answer this question, you have to decide how critical it is to maintain your product integrity.
Whether you are working on a clinical trial or just simply shipping your biologics to another location under controlled temperature conditions, it is extremely important that you have a shipping container and temperature data loggers that can be counted on each and every time of use. Most people look for commercial off-the-shelf solutions, which may or may not be adequate for your particular needs. If not, the shipper can result in loss of very valuable (and sometimes irreplaceable) materials. Performing your due diligence, through either your own internal testing or working with a reliable external partner, can help reduce the chance that your chosen shipper and temperature loggers will not live up to your given requirements.
Evaluating your shipper through worst case scenarios (taking into account seasonality, transport duration, and mode) and finding out the results upfront will allow you to apply the needed fixes, and also save your organization significant funds. Knowing how well a shipper performs up front can help keep your clinical trials on time and your product integrity unquestioned.
Due diligence in evaluating a shipper means asking the right questions. How much thermal load is enough? The proper amounts of dry ice or LN2 need to be calculated out and include a good margin of error in case of unexpected delays, such as delivery to the wrong location or a long delay in customs.The same principle of proportion applies to PCM (Phase Change Material) shippers as well. Sometimes it’s best to use a “White Glove” service, such as World Courier, Priority Solutions International, or Fed-Ex Custom Critical to overcome these potential issues. These services include replenishing LN2, dry ice, ice packs, etc. at the point of delay. A transit study will help you determine when this service is cost-effective.
Spending a little effort and modest resources upfront can help you avoid a shipping disaster down the road. The Fisher BioServices Quality Assurance Manager, Praveen Bezawada-Joseph discusses the importance of patient safety and regulatory compliance in cold chain logistical systems in the eBook, "Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics".
Can your organization afford a major setback during a clinical trial by losing patient biologics or trial drugs? You can greatly reduce your chances by investing some time and money in a shipping/transit study before your big event begins. I'd be interested in learning about your biologics transport challenges. Please share your comments below.