In biologics manufacturing, achieving optimal yield while ensuring compliance, product quality, and operational efficiency remains a constant balancing act. Advances in Process Analytical Technology (PAT), artificial intelligence, and raw material analytics are enabling leaders to move beyond reactive problem-solving toward proactive, data-driven decision-making. This session takes a strategic look at how these technologies can be integrated into validation frameworks, applied to process monitoring, and scaled across multiple sites — all while maintaining regulatory rigor. Drawing on practical experiences from large-scale operations, we will explore how predictive insights and real-time data can drive measurable gains in yield, reduce variability, and streamline technology transfer. In this session you will learn how to:

• Embed process analytics and AI into validation and continued process verification to enhance predictability and control.
• Apply raw material analytics to identify variability drivers and improve manufacturing robustness.
• Align technology deployment with regulatory expectations and operational scalability across global networks.