Considering the clinical supply chain in vaccine trials: Special handling required


Vaccines are one of the most useful and cost-effective means of reducing illness and death from infectious diseases. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today. The interest in vaccines is fueled by a variety of factors. Among them: The COVID-19 pandemic, the impact of globalization, technological advances in biotechnology, post 9/11 concerns about biological warfare, the emergence and reemergence of diseases such as West Nile Virus and tuberculosis, and scientists’ pursuit of new vaccine targets such as cancer and Alzheimer’s disease. Another key contributor is the recognition by principal vaccine purchasers—healthcare providers and governments, whose ranks have swollen to include those of emerging markets such as China and India— of the ability of vaccines to reduce healthcare expenditures and increase quality of life through disease prevention.

The renewed investment in vaccine development has been accompanied by formidable challenges—both for biopharmaceutical research companies pursuing the next generation of products, as well as the clinical supply chain industry, to which responsibility for packaging, labeling, storing and delivering vaccines for global clinical trials has been outsourced. 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,” a strict system of temperature and stock control to assure their potency and safety. Successful 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.

Thermo Fisher Scientific is a global leader in clinical trial supplies through its Patheon™ Fisher Clinical ServicesSM offering. Today, half of our projects involve controlled temperature or cold chain products, a proportion that has been increasing steadily as the number of global vaccine trials escalate. This paper discusses how we are meeting the challenges of cold supply chain for global vaccine studies. Also included are planning recommendations for biopharmaceutical companies preparing to scale up to global vaccine trials