Journal
PHARMACEUTICAL RESEARCH
Volume 31, Issue 11, Pages 3006-3018Publisher
SPRINGER/PLENUM PUBLISHERS
DOI: 10.1007/s11095-014-1394-3
Keywords
pilot scale-up; spray drying; thermostable; vaccines
Funding
- Defense Threat Reduction Agency
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Stable vaccines with long shelf lives and reduced dependency on the cold chain are ideal for stockpiling and rapid deployment during public emergencies, including pandemics. Spray drying is a low-cost process that has potential to produce vaccines stable at a wide range of temperatures. Our aim was to develop a stable formulation of a recombinant H1N1 influenza hemagglutinin vaccine candidate and take it to pilot-scale spray-drying production. Eight formulations containing different excipients were produced and assayed for antigen stability, powder characteristics, and immunogenicity after storage at a range of temperatures, resulting in the identification of four promising candidates. A pilot-scale spray-drying process was then developed for further testing of one formulation. The pilot-scale process was used to reproducibly manufacture three batches of the selected formulation with yields > 90%. All batches had stable physical properties and in vitro potency for 6 months at temperatures from -20A degrees C to +50A degrees C. Formulations stored for 3 months elicited immunogenic responses in mice equivalent to a frozen lot of bulk vaccine used as a stability control. This study demonstrates the feasibility of stabilizing subunit vaccines using a spray-drying process and the suitability of the process for manufacturing a candidate product.
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