Publications by authors named "Heidi Pixley"
Dengue fever has remained a continuing global medical threat that impacts half of the world's population. Developing a highly effective dengue vaccine, with live-attenuated tetravalent vaccines as leading candidates, remains essential in preventing this disease. For the development of live virus vaccines (LVVs), potency measurements play a vital role in quantifying the active components of vaccine drug substance as well as drug product during various stages of research, development, and post-licensure evaluations.
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- Vaccine thermal stability relies on formulation factors like pH and ionic strength, which can be predicted based on scientific knowledge and experience.
- Support from experimental data is necessary for regulators to validate stability claims, as predictions alone are insufficient.
- The Design of Experiment (DoE) approach enables deeper understanding of how these formulation factors affect thermal stability, even in cases where the underlying mechanisms are not fully understood; this was exemplified in a study of an aluminum adjuvant vaccine showing formulation differences within just 15 days.