Enabling a PAT Continuum from Development to Commercial Manufacturing While Aligning with Regulatory Expectations

• Establishing a continuum from R&D through MSAT to commercial manufacturing, integrating PAT, digital twins, and automated processes to support real‑time decision‑making and continuous manufacturing across modalities
• Addressing key implementation challenges including demonstrating business value, managing evolving AI/ML capabilities, and ensuring systems are sufficiently mature for GMP deployment
• Exploring pathways to replace traditional QC release testing with real‑time monitoring, while driving regulatory acceptance, ensuring compliance, and upskilling cross‑functional teams

Speakers:

Luc Nguyen

Global Head PAT & Advanced Process Controls - Practices Excellence and Innovation - MSAT

Sanofi