Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study.
Appl Microbiol Biotechnol
; 108(1): 359, 2024 Jun 05.
Article
en En
| MEDLINE
| ID: mdl-38836885
ABSTRACT
Vacuum foam drying (VFD) has been shown to improve the thermostability and long-term shelf life of Newcastle Disease Virus (NDV). This study optimized the VFD process to improve the shelf life of NDV at laboratory-scale and then tested the optimized conditions at pilot-scale. The optimal NDV to T5 formulation ratio was determined to be 11 or 32. Using the 11 virus to formulation ratio, the optimal filling volumes were determined to be 13-17% of the vial capacity. The optimized VFD process conditions were determined to be at a shelf temperature of 25â with a minimum overall drying time of 44 h. The vaccine samples prepared using these optimized conditions at laboratory-scale exhibited virus titer losses of ≤ 1.0 log10 with residual moisture content (RMC) below 3%. Furthermore, these samples were transported for 97 days around China at ambient temperature without significant titer loss, thus demonstrating the thermostability of the NDV-VFD vaccine. Pilot-scale testing of the NDV-VFD vaccine at optimized conditions showed promising results for up-scaling the process as the RMC was below 3%. However, the virus titer loss was slightly above 1.0 log10 (approximately 1.1 log10). Therefore, the NDV-VFD process requires further optimization at pilot scale to obtain a titer loss of ≤ 1.0 log10. Results from this study provide important guidance for possible industrialization of NDV-VFD vaccine in the future. KEY POINTS ⢠The process optimization and scale-up test of thermostable NDV vaccine prepared through VFD is reported for the first time in this study. ⢠The live attenuated NDV-VFD vaccine maintained thermostability for 97 days during long distance transportation in summer without cold chain conditions. ⢠The optimized NDV-VFD vaccine preparations evaluated at pilot-scale maintained acceptable levels of infectivity after preservation at 37â for 90 days, which demonstrated the feasibility of the vaccine for industrialization.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Temperatura
/
Virus de la Enfermedad de Newcastle
/
Vacunas Virales
/
Enfermedad de Newcastle
Límite:
Animals
País/Región como asunto:
Asia
Idioma:
En
Revista:
Appl Microbiol Biotechnol
Año:
2024
Tipo del documento:
Article
País de afiliación:
China