Issue link: https://www.e-digitaleditions.com/i/1373953
38 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations N ow that COVID-19 vaccines have received regulatory authorizations and vaccine manufacturers are provid- ing a steady and increasing supply, the focus is on dis- tributing doses. Vaccine manufacturers worked closely with cold-chain distribution experts to plan for maintaining and monitoring the cold chain for these crucial drug products. The vac- cines must be transported and stored at temperatures ranging from refrigerated (2–8 °C) to frozen (-20 °C) or in deep-freeze, with spe- cific requirements depending on the manufacturer and vaccine type. Pfizer and BioNTech's COVID-19 vaccine was authorized with the most stringent requirements of the currently authorized products, with storage between -80 and -60 °C, and the vaccine is being shipped in thermal containers designed to hold dry ice for both shipping and temporary storage. The companies said in late February 2021 that they had demonstrated stability of the vaccine when stored at -25 to -15 °C and would apply for an updated label that would allow storage at these typical freezer temperatures for up to two weeks (1). Many suppliers from all parts of the distribution chain—from makers of thermal packaging, sensors, data loggers, and supply- chain visibility systems to dry ice suppliers and airlines—stepped up to prioritize vaccine distribution, and in some cases modified existing technologies to meet the requirements (2). "We have seen tremendous efforts across the COVID-19 vaccine distribution channel, with parties coming together to help solve a common goal for humanity," says Gisli Herjolfssonn, CEO and cofounder of Controlant, headquartered in Iceland, which is pro- viding monitoring and supply-chain visibility services to Pfizer for Tracking Technologies Safeguard Vaccine Cold Chain Jennifer Markarian Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future. DANIEL - STOCK.ADOBE.COM