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- Title
Stabilization of HAC1 Influenza Vaccine by Spray Drying: Formulation Development and Process Scale-Up.
- Authors
Zhu, Changcheng; Shoji, Yoko; McCray, Scott; Burke, Michael; Hartman, Caitlin; Chichester, Jessica; Breit, Jeff; Yusibov, Vidadi; Chen, Dexiang; Lal, Manjari
- Abstract
Purpose: 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. Methods: 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. Results: 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 −20°C to +50°C. Formulations stored for 3 months elicited immunogenic responses in mice equivalent to a frozen lot of bulk vaccine used as a stability control. Conclusions: 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.
- Subjects
INFLUENZA vaccines; DRUG stability; SPRAY drying; DRUG development; LABORATORY mice; DRUG factories; PANDEMICS
- Publication
Pharmaceutical Research, 2014, Vol 31, Issue 11, p3006
- ISSN
0724-8741
- Publication type
Article
- DOI
10.1007/s11095-014-1394-3