Florent Peral studied bioprocess in Ecole de Biologie Industriel –EBI in Cergy Pontoise, France and received his MSc in 2009.
He spent 2 years in Genzyme Lyon as bioprocess associate on polyclonal antibodies DSP manufacturing.
Subsequently, he held a position for 3 years at LFB Biotechnologies, focusing on formulation and lyophilization process development on plasmatic and recombinant proteins. After 18 months working on lentiviral vector used for gene transfer at the biotech startup Theravectys, he joined Sanofi Pasteur as a formulation scientist in October 2016.
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.View Details