Pharmaceutical Lyophilization
Summit 2019
Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.
- 13 Feb 2019
- Prague, CZ
- Pharma
Day 2:
Thursday, 14 February 2019
BLOCK: FORMULATION DEVELOPMENT.
CASE STUDY: Inactivated Zika virus vaccine – fast track drug product development – formulation and lyophilization design space study.
The Zika virus (ZIKV) epidemic which occurred throughout Latin America, led The World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PEIC) in February 2016. An inactivated Zika vaccine, developed by the Walter Reed Army Institute of Research, was found to be protective in animal models.
This vaccine was transferred to Sanofi Pasteur where the viral seed was regenerated in serum-free Vero cells and process development was carried out to produce material to be used for further pre-clinical and clinical evaluation.
The case study reported here focuses on the fast track drug product development with a strategy driven by a process/ product risk analysis to support the selection of the appropriate stabilizing formulation and freeze-drying process.
Finally a Design of experiment approach is presented where the combination effect of formulation and lyophilization parameters are assessed in a design space study.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002016000039C.
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