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Climatic Concerns

As the number of large-scale clinical trials continues to increase globally, connecting countries and regions thousands of miles apart, pharmaceutical and biotech firms now face complex challenges in maintaining control and visibility of temperature-sensitive materials on a global scale. Temperaturesensitive biomaterials, such as clinical trial samples, cell banks, tissue samples, microbiological and viral samples, are invaluable to biopharmaceutical developers, as they play a vital role in clinical research.

A product of today’s multi-million dollar research investments, as well as tomorrow’s multi-billion dollar potential revenue, well-managed biomaterial samples can bring significant long-term value to drug developers. As evidence, the value of these materials is rapidly increasing as novel discoveries can be made from their use in ongoing clinical testing. For example, high-throughput analysis of biological samples has led to recent advances in molecular and genetic epidemiology, enhancing the possibility of identifying individuals with genetic risk for certain cancers. Furthermore, the use of biomarkers is helping to rapidly advance studies of cancer etiology, detection, treatment and prognosis (1).

To realise such benefits and breakthroughs, it is of paramount importance that samples are maintained in the best possible condition, and a history of the samples’ logistics and storage kept in the greatest possible detail. However, despite having standard operating procedures for many aspects of clinical research and development, companies often overlook one critical step: developing a strategy for the specialised shipment of biological samples.

TRANSPORTING TEMPERATURE-SENSITIVE SAMPLES AND SUPPLIES

To capitalise on the intrinsic value of these samples, biotech and pharmaceutical companies, both large and small, must understand the importance of implementing a comprehensive cold chain strategy for transporting temperature-sensitive biological samples and clinical supplies. An effective cold chain strategy defines how temperature-sensitive products and biomaterials are packaged, transported and stored throughout the research and development process. Maintaining the integrity of the cold chain requires logistics and management expertise to ensure that temperature-sensitive samples are constantly monitored and properly packaged, so they do not degrade during packing, shipping, processing and storage.


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Jeff Clark is Director of Global Logistics for BioStorage Technologies, a dedicated biorepository service provider that stores, ships and manages temperature-sensitive biomaterials for pharmaceutical and biotechnology firms worldwide. As Director of Global Logistics, Jeff Clark oversees BioStorage Technologies’ day-to-day cold chain logistics for the US and Europe. Jeff holds a diploma from the International Air Transport Association (IATA) and International Federation of Freight Forwarders Association (FIATA). He has also earned certifications in international rates and tariffs, advanced cargo agent 803-53/01 and IATA hazmat training.
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