Compositions and methods for stabilizing live-attenuated flaviviruses
A stabilizer formulation with trehalose, PVP 10, CaCl2, L-Proline, a poloxamer, and urea addresses the stability issues of live-attenuated flaviviruses during freeze-drying, maintaining potency and reducing excipient use, suitable for industrial-scale vaccine production.
Patent Information
- Application Number
- PCT/EP2025/078817
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-10-08
- Filing Date
- 2025-10-07
- Publication Date
- 2026-04-16
AI Technical Summary
Existing live-attenuated flavivirus vaccines face stability challenges during freeze-drying processes, particularly due to the macromolecular complexity of intact viruses, leading to reduced efficacy, and there is a need for stabilizers that can be used at an industrial scale with a reduced number of excipients, including sorbitol and proteins.
A stabilizer formulation comprising trehalose, PVP 10, CaCl2, L-Proline, a poloxamer, and urea, with a dry content between 5% and 20%, devoid of sorbitol and proteins, is used to stabilize live-attenuated flaviviruses during freeze-drying.
The formulation maintains the potency of live-attenuated flaviviruses under thermal stresses, reducing the loss of infectious titer and enhancing stability, even in the absence of sorbitol and proteins, suitable for industrial-scale vaccine production.