Continuous spin-freeze-drying of a live attenuated viral vaccine
EducationalEmbracing innovation: towards a new paradigm for Freeze-drying
2025-06-05 | 01:20 PM - 01:35 PM | TPD Room
Information
Live attenuated viral vaccines (LVV) are inherently thermolabile, necessitating lyophilization to preserve their efficacy over extended storage periods. Recently, alternative drying methods such as continuous spin-freeze-drying (CSFD) have been explored as cost-effective and faster approach for stabilizing biopharmaceuticals.
This research compares emerging drying technique with conventional batch freeze-drying (BFD) regarding process efficiency and the preservation of viral titer during both dehydration and storage. A stress-sensitive LVV was used as a model to identify stress factors associated with this rapid drying technology. The drying parameters were optimized, and the resulting doses were assessed for process and storage stability.
Our findings demonstrate that the viral titer was predominantly affected by water removal, whereas unit operations that improve heat and mass transfer did not negatively impact viral infectivity. Doses produced using optimized CSFD retained potency comparable to BFD. A two-week accelerated stability study at 37°C indicated that CSFD maintained LVV stability comparable to BFD.