Mostafa Nakach is PhD from Toulouse University. He has prepared his thesis on stabilization and production of nanocrystalline suspension. He is also Master 2 graduate from Paris-sud 11 university in Pharmacotechnie and Biopharmacy and Pharmaceutical engineer from Ecole des Mines d’Albi . Mostafa is working within sanofi group since 29 years. His current position is a head of pharmaceutical engineering section within pharmaceutical science operations.
His mission is to build and to manage the required skills and capabilities in order to support R&D projects development mainly for:
- Formulation design of nano-vectors
- Fill&finish Commercial process development of biotech products
- Development and adaptation to pharmaceutical regulation of new manufacturing processes (nanotechnologies, amorphization, spray drying, freeze drying etc….)
- identification of critical steps and relevant monitoring to manufacture a product exhibiting the expected quality attribute
- implementation of pharmaceutical engineering tool box that will contribute to the implementation of QBD approach
- modelling scale down and scale-up rules
- design and set-up/qualification/validation of equipments and pilots aimed at manufacturing nanotechnology-based product
Mostafa Nakch worked also as API physical quality research engineer within chemical development department. His mission was focused on the process development of solid chain: from crystallization to particles engineering.