Théodore Clavreul

Manufacturing, Qualification & Validation Engineer @CONSULTYS

Lyon, FR

Project : Support to industrial development teams in the framework of process validation and viral safety demonstration for pAbs Tasks included : •Coordination and preparation of non-GLP viral clearance studies •Qualification of scale-down models in collaboration with process development teams, including strategy definition, protocol drafting, and review •Design and execution of stability studies for intermediate process steps assessed during viral clearance studies, including planning, protocol writing, and coordination with Development, Analytical, and Quality Control departments •Project follow-up and communication with external testing laboratories (Charles River) Equipment included : •Purification processes (chromatography, nanofiltration, pasteurization)