The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides an industry overview and a framework for discussion. The importance of a robust supply chain is addressed. It includes planning recommendations for biopharmaceutical companies preparing to scale up to global vaccine trials.
‘Cold chain management’ is undoubtedly a hot topic in the clinical research industry because a rising percentage of the drugs in clinical testing today are biologics. The percentage of pharmaceuticals based on biologics and vaccines has grown tremendously in the past decade. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today. In 2016, biologics accounted for six of the top-eight drugs, in terms of revenue. In fact, the global biologics market size is expected to reach around $319 billion by 2021 at an annual growth rate of 9.6%, more than twice the growth rate of conventional pharmaceuticals.
New drug development is accompanied by formidable challenges, both for biopharmaceutical research companies pursuing the next generation of products, as well as the clinical supply chain partners. These partners often take responsibility for packaging, labeling, storing and delivering IMP for global clinical trials. In addition to their cost and complexity to develop and manufacture, vaccines must be stored, transported and maintained at controlled temperatures in a “cold chain environment.” Maintaining cold supply chain demands planning, partnering and attention to detail; a single broken link can result in loss of scarce resources and time, the twin currencies of the biopharmaceutical industry.