Dr Mostafa Nakach | Head of Pharmaceutical Engineering
Sanofi Aventis

Dr Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi Aventis

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:
 

  1. Formulation design of nano-vectors
  2. Fill&finish Commercial process development of biotech products
  3. Development and adaptation to pharmaceutical regulation of new manufacturing processes (nanotechnologies, amorphization, spray drying, freeze drying etc….)
  4. identification of critical steps and relevant monitoring to manufacture a product exhibiting the expected quality attribute
  5. implementation of pharmaceutical engineering tool box that will contribute to the implementation of QBD approach
  6. modelling scale down and scale-up rules
  7. 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.

Appearances:



EAC 2017 Day 1, Tuesday 31st October 2017 @ 14:10

Fill and finish processing of biopharmaceutical manufacture

  • Basic data acquisition focusing on the main physical chemistry properties of the drug product.
  • Preliminary calculations of process parameters based on prior knowledge using simulation tools in order to anticipate process parameters of freezing, thawing, mixing, filtration and filling parameters.
  • Set-up of Design space using Lab scale tests for each operation units in order to fine tune the calculation results. Thanks to preliminary calculations the number of experiments to be performed is reduced.
  • Set-up of robust and efficient scale-up that can leads to stable products in the monitored quality attributes
 

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