Nicolas Urbieta | USP Scientist
Sanofi Pasteur

Nicolas Urbieta, USP Scientist, Sanofi Pasteur

Nicolas earned his PharmD from the University of Bordeaux and Dipl. Ing from the Institute of Biotechnology of Bordeaux. He has occupied various positions in the biopharmaceutical industry. While working at Merck Serono, Switzerland, he helped define the Process control Strategy for a commercial molecule. Nicolas now works as an USP scientist in the late stage development department at Sanofi, managing the team in charge of the upstream process characterization of a new biologic molecule.


Advanced Therapies and Regenerative Medicine Day 2 - Thursday 17th May 2018 @ 14:30

Defining a robust cell culture process control strategy for biologics launch processes – the application and limitations of small-scale and large-scale data

  • Process Control strategy prerequisites – CQA determination and Process Risk assessment (FMEA)
  • SSM Qualification
  • Process Characterization Studies: from De-risking to PAR studies – PAR calculation for critical parameters, NOR definition

back to speakers

World Advanced Therapies & Regenerative Medicine Congress


Erica Baeta
+44 (0)207 092 1152


Jessica Robinson
t/ +44 (0)207 092 1150


Issa Mauthoor
+44 (0)207 092 1257