4^th Annual Conference & Exhibition

Mostafa Nakach

Sanofi Aventis - Head of Pharmaceutical Engineering

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.

J. JEFF SCHWEGMAN

CEO - AB Biotechnologies

Dr. J. Jeff Schwegman is the Founder and CEO of AB BioTechnologies where he manages the day to day operations of the company. Dr. Schwegman received his Ph.D. from Purdue University in 2003 and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. He specializes in speaking and consulting in parenteral preformulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules.In November 2005, he left Baxter and formed a life science company which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he formed AB BioTechnologies.