Session: Bioprocess & Cell Line Development

This session explores how emerging technologies—digitalization, process automation, AI-driven decision-making, and advanced data analytics—are transforming drug substance and drug product development, enhancing efficiency, quality, sustainability, and flexibility in pharmaceutical manufacturing while reducing waste, energy consumption, and carbon footprint. Topics of interest include, but are not limited to: •Advanced Process Automation: AI-driven control strategies, robotics, and IoT-enabled manufacturing. •Digital Twins & Process Modeling: Enhancing predictive control and risk mitigation in development and scale-up. •Smart Data Utilization: AI/ML applications for process optimization, root cause analysis, and quality control. •Hyperconnected Manufacturing: The role of cloud computing, cyber-physical systems, and digital supply chains in Pharma 5.0. •Real-Time Monitoring & Control: Integration of PAT, continuous process verification, and adaptive manufacturing strategies. •Human-Centric Digitalization: Augmented reality, operator-assist AI, and collaborative robotics in pharmaceutical production. •Regulatory & Compliance Considerations: Adapting digital and automated workflows to evolving regulatory landscapes. This session aims to showcase how Pharma 5.0 builds on the foundations of Pharma 4.0, leveraging automation, AI, and digital connectivity to create more agile, intelligent, efficient, and sustainable pharmaceutical manufacturing ecosystems.