Pre-Conference Day

This interactive workshop moves beyond theory to explore how real‑time process monitoring and predictive control are being practically applied across pharmaceutical and biotech development and CMO/CDMOs. Through real‑world case studies and facilitated group discussions, industry experts will demonstrate how sensors, PAT, and advanced analytics are being used to surface actionable insight earlier; when it matters most.

Learn how to detect deviations earlier, improve decision‑making, and reduce batch failure risk, while overcoming the organizational, technical, and operational barriers to adoption. Designed to be highly participatory, this workshop will equip attendees with concrete learnings they can take back to their development labs and manufacturing sites, thus helping turn real‑time data into predictive, process‑ready control strategies.

Industry experts will cover:

• Applying machine learning models and digitized process development data, to identify edge case scenarios and predict potential impacts on critical quality attributes in real time
• Using models as decision support tools to enhance confidence in PARs, improve anomaly detection, and support batch disposition while maintaining established quality and investigation processes
• Addressing key challenges in validating ML based approaches, establishing governance frameworks, and demonstrating commercial value
• Determining when process monitoring and PAT integration meaningfully enhances process understanding, supports robust control strategies, and justifies investment
• Implementing data collection and monitoring tools to provide a holistic view of aseptic processes, enabling stronger decision making, improved control, and long-term manufacturing performance

As process monitoring evolves from a supporting activity into a dedicated, value‑driving function, many organizations face the same challenge: how to integrate new technologies without disrupting validated processes or manufacturing continuity. This workshop brings together industry peers to share practical experiences of introducing and scaling new tools in real GMP environments.

Through real‑world case studies, participants will explore how autosamplers, advanced sensors, digital platforms, and AI are being applied in practice; what worked, what didn’t, and why. Highly collaborative and discussion‑led, this workshop is designed to help attendees understand not just what technologies are available, but how to implement them successfully, turning process monitoring into a sustainable capability that delivers long‑term manufacturing value.

This workshop will gather experts to discuss:

• Showcasing new uses of Raman spectroscopy beyond its traditional biologics applications to unlock new process insights across modalities
• Discussing the use of online LC in biologics downstream processing, highlighting both its potential and current limitations in wider industry adoption
• Exploring how these innovations enable deeper process understanding, improve control strategies, and ensure successful transfer to manufacturing
• Actualizing improved manufacturing efficiencies through improved yields, control of cycle times, and reductions in testing all while increasing the level of product monitoring
• Scaling proven technologies across products lines to maximize ROI, improving continuous process improvement efforts, drastically improving capabilities for future process development efforts while enabling consistent, streamlined process monitoring at scale