Session: Continuous Processing in Drug Substance

This session focuses on advancements in continuous processing for both drug substance and drug product manufacturing for improving process robustness, product quality, and supply chain reliability. We invite submissions that explore novel technologies, process design strategies, control methodologies, and case studies demonstrating the benefits and challenges of continuous processing in pharmaceutical development and commercialization. Topics of interest include, but are not limited to: •End-to-end continuous manufacturing approaches for small and large molecules. •Innovations in reactor and crystallization design for continuous drug substance production. •Continuous blending, granulation, tableting, and coating for drug product manufacturing. •Process modeling and digital twins to support continuous operations. •Process analytical technology (PAT) and real-time release testing (RTRT) for process monitoring and control. •Regulatory considerations and strategies for continuous manufacturing adoption. •Scaling and technology transfer of continuous processes from development to commercial scale. This session aims to showcase the latest innovations and best practices in continuous pharmaceutical manufacturing, addressing the scientific, technical, and regulatory perspectives that drive its successful implementation.