By harmonizing platform knowledge, high-throughput process development, early risk-based validation, and digital ecosystems, Lab-in-a-Loop enables rapid development, single-cycle learning, and keeps CMC off the critical path. Impactful outcomes include fast DNA-to-IND progress, achieving a 12-month acceleration in development timelines for mAbs and ADCs through cross-functional playbooks and molecular engineering. In cell culture process characterization, hybrid modeling—combining mechanistic models with prior knowledge—has cut resource utilization and timelines by ~50%, while supporting commercial robustness and lifecycle management. Autonomous data analysis using Bayesian optimization in purification has outperformed traditional design-of-experiment approaches, delivering higher yields and product quality with fewer experiments. Digital Twin deployment, leveraging contextualized metadata and neural network modeling, enables predictive manufacturing performance and harmonization across global sites.
The session will close by reflecting on lessons learned from scaling biologics and how augmented intelligence—combining human expertise with advanced digital tools—can drive rapid, high-quality development and expedite new medicines to patients worldwide.