Nordic Life Science 1
TOBIAS KUNERS OF KOENDERS, MANAGING CONSULTANT, T
OB MANAGEMENT he proper packaging and shipping of drugs, medical equipment and food for medical purposes has become a major industry all of its own. One of the top consultants in the field, Tobias Kuners of Koenders, managing consultant at Tob Management, a Netherlands-based consulting firm, advises small and medium-sized pharmaceutical and biotechnical companies to do sufficient work ahead of time to ensure they have the most effective shipping and transport validation strategy possible when their products leave the warehouse. “Shipping and transport strategies and execution are often started late in the development of products,” Kuners of Koenders told Nordic Life Science. “Some of the elements of the strategy should be started early on, and have others already in place in the laboratory setting by gathering intelligence to help shape the actual validation with placebo and final product.” When crafting shipping and transport strategies, patient safety is always the priority. The factors companies take into account in developing their strategies depend, logically, on the nature of their products. “Tablets are less sensitive to temperature variations compared to liquids, and biologics are much more sensitive again,” according to Kuners of Koenders. “Biologics may also be more sensitive to vibration. Powders may be sensitive to becoming lumps when you want them to be fine powders. A good risk assessment with people from product development, quality, engineering and qualification should identify the most important and critical factors. When you make such assessments early on you can design your strategy to tackle the issues while going along the product life cycle.” Companies should also work backwards from the commercial to the pre-clinical stage when developing strategies, Kuners of Koenders advises. “A lot of first results can be obtained in the laboratory, testing stability; chemical and physical effects, UV, heat and vibration. Those results provide input to the actual transport validations that need to be executed with the actual products. Here, also, many trials can be tested with a placebo product.” Depending on the stage the products are in – pre-clinical, clinical, phase I/II, phase III or commercial – they should grow to a more mature level of addressing the validation, according to Kuners of Koenders. “To do that effectively, they need to plan in reverse. In the early stages, companies do not have resources to do everything, but for instance a stability study takes time and if they can start one early, they can gather data over an extended time, which will benefit them at the filing,” he says. If a company is close to launching a product and knows its first markets, it can have actual transport validation runs to those, Kuners of Koenders advises, but early on the company needs to develop an approach and work on those activities that need to be done in all cases, and use the results from the first markets in other areas with similar conditions. Some of the biggest challenges in developing an effective strategy are finding the right balance between the markets the companies want to serve, the transport modes to bring products to those markets, the risks identified and the money needed to perform such trials. One of the trends in global shipping of which companies should be aware is the move to cold chain, with temperatures between 2 – 8 °C, or -20 °C for biologics, which require even more rigorous design and execution of transports, Kuners of Koenders says. Monitoring products during shipment is essential, he adds. “For temperature, data loggers are used; at least two per shipment, and usually