Episode 1: PAT Applications:
Where It Works, Where It Struggles,
and Why It Matters

Two decades after regulators first championed Process Analytical Technology (PAT) in 2004, many pharmaceutical manufacturers are still grappling with its adoption. PAT involves real-time measurement and control of critical quality attributes during manufacturing, shifting quality control from end-point testing to continuous monitoring. This approach allows for immediate process adjustments, improved understanding, and the potential for real-time product release.

In this video interview, biotechnology veteran Marina Kirkitadze (consultant at BioCraft Research with 30+ years in biopharma, including vaccine R&D and global regulatory experience) offers a candid look at where PAT works, where it struggles, and why it matters. Drawing on her extensive industry perspective, Marina discusses proven successes of PAT, the challenges hindering wider adoption, and how real-time, knowledge-driven manufacturing can transform quality and business outcomes today.