Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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20 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing wasted, a number still cited by the United Nations Environment Programme (1). Although this figure includes both closed and open vial wastages, errors in storage and transportation—mainly due to the specific storage temperature requirements of the vaccine products—are a major cause of lost doses of crucial vaccines. Developed nations with established cold-chain distribution networks and infrastructure are not im- mune to the loss of vaccines due to temperature fluc- tuations. The French Directorate General of Health has estimated a 30% wastage rate on COVID-19 vaccines distributed within the country (2). Product stability-related wastage is expected to be high. Vac- cine distribution in the developing world countries is even more challenging. Vaccines that have been inactivated due to inappropriate storage may still be used if proper monitoring systems are not in place to detect mishandling. With a global need to vaccinate billions of people, reducing vaccine waste should be a key aim of all roll- out programs to ensure this precious commodity is used as intended. While current COVID-19 vaccine distribution will continue with the defined stability N 2 in Atomizer Gas Drying Gas Mass Flow Controller Mass Flow Controller 0.2 µm Inlet Filter 0.2 µm Inlet Filter Electrical Heater DRYING CHAMBER Atomizer Nozzle Formulation Vessel with Stirring Peristaltic Feed Pump Product Collection CYCLONE Outlet HEPA Filter Exhaust out Figure 1. Basic steps of aseptic spray drying. Table I. Shelf life and storage conditions of some of the approved COVID-19 vaccines. Vaccine Type of vaccine Unopened shelf life Shelf life once opened Pfizer/BioNTech mRNA • 6 months stored between -80 °C and -60 °C • 5 days once thawed and refrigerated between 2–8 °C After dilution, must be stored at –25 °C and used within six hours AstraZeneca/ Oxford University Viral vector • 6 months stored at 2–8 °C Must be stored at 2–25 °C and used within six hours Moderna mRNA • 7 months stored at -25 °C to -15 °C • 30 days once thawed and refrigerated between 2–8 °C Must be stored at 2–25 °C and used within six hours Johnson & Johnson's Janssen COVID-19 Vaccine Viral vector • 3 months stored at 2– 8°C or 2 years stored at -20 °C Must be stored at 2–8°C and used within six hours ALL FIGURES COURTESY OF THE AUTHOR.

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