Abstract
Spray dried vaccine formulations might be an alternative to traditional lyophilized vaccines. Compared to lyophilization, spray drying is a fast and cheap process extensively used for drying biologicals. The current study provides an approach that utilizes Design of Experiments for spray drying process to stabilize whole inactivated influenza virus (WIV) vaccine. The approach included systematically screening and optimizing the spray drying process variables, determining the desired process parameters and predicting product quality parameters. The process parameters inlet air temperature, nozzle gas flow rate and feed flow rate and their effect on WIV vaccine powder characteristics such as particle size, residual moisture content (RMC) and powder yield were investigated. Vaccine powders with a broad range of physical characteristics (RMC 1.2–4.9%, particle size 2.4–8.5μm and powder yield 42–82%) were obtained. WIV showed no significant loss in antigenicity as revealed by hemagglutination test. Furthermore, descriptive models generated by DoE software could be used to determine and select (set) spray drying process parameter. This was used to generate a dried WIV powder with predefined (predicted) characteristics. Moreover, the spray dried vaccine powders retained their antigenic stability even after storage for 3 months at 60°C. The approach used here enabled the generation of a thermostable, antigenic WIV vaccine powder with desired physical characteristics that could be potentially used for pulmonary administration.
Highlights
Many existing vaccines are currently distributed and administered in a liquid form
To gain more insight in the relation between input parameters on the responses, a reduced Central Composite Family (CCF) design was adopted for further optimization of process parameters (Table 2)
After spray drying and analyzing the formulations of the CCF design, multiple linear regression (MLR) models were fitted for each output parameter
Summary
Many existing vaccines are currently distributed and administered in a liquid form. Liquid vaccines need to be stored at 2–8 C to remain stable. This dependency on a steady cold chain makes vaccine distribution complex and expensive, especially in developing countries (Wang, 1999). Dried vaccines can overcome this requirement for a cold chain, as they possess a longer shelf life at elevated temperatures (Geeraedts et al, 2010; Smith et al, 2015). 3 Current address: Virtuvax BV, The Netherlands
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