Day One

• Building a comprehensive data foundation and process monitoring capability at a single site, establishing a lighthouse model for the broader organization
• Navigating stakeholder misalignment and organizational resistance over a multi-year journey to align on a shared vision and secure enterprise-wide mandate and investment
• Driving data & AI-driven culture in GMP manufacturing by aligning cross-functional teams on execution, governance, trust, and ownership

• Sharing practical successes and setbacks when implementing autosamplers, advanced sensors, spectroscopic tools (e.g. Raman, NMR), and digital platforms from proof of concept through to scale out
• Navigating change control, risk, and product launch pressures, particularly in aseptic manufacturing – while introducing new technologies such as real time release testing and updated control strategies
• Advancing towards instant release and more efficient manufacturing for antibodies and peptides through integration of PAT, digital tools, and novel analytical technologies

As the process monitoring community officially unites for the first time, this valuable session will ensure you get the chance to reconnect with peers and make brand new connections!

This structured networking opportunity will pair you with fellow attendees for several 3-minute introductions, ensuring you have the opportunity to meet and network with your industry colleagues.

• Implementing a coherent data strategy to aggregate data from diverse sources, enabling teams to quickly retrieve and review critical process information during GMP operations
• Moving from unstructured data streams to contextualised, usable information that supports collaborative, data driven troubleshooting and continuous process improvement
• Enabling near real time visibility across development and manufacturing to accelerate root cause analysis, optimise processes, and improve overall manufacturing performance

• Moving past regulatory‑minimum SPC by applying PCA‑based and dynamic multivariate statistical process monitoring (MSPM) to better capture the complexity of upstream processes in late‑phase mAb manufacturing
• Demonstrating how simulated (in silico) datasets can supplement limited experimental data, enabling the development and continuous refinement of MSPM models as they are deployed and scaled toward manufacturing environments
• Sharing lessons learned in updating and transferring models into real‑world use, while addressing challenges around GMP integration, validation, and the practical limitations slowing broader industrial adoption of MSPC

• Defining who owns technology, data, and decision making at each stage, from early development through tech transfer and into GMP manufacturing, to prevent gaps that stall adoption
• Addressing the practical steps required to contextualize data, integrate systems into workflows, and ensure data management tools actively support process monitoring and decision making
• Sharing lessons learned from driving organizational alignment, ownership, and accountability to ensure successful implementation and sustained use across sites and functions

• Expanding monitoring from final identity and purity assays to in‑process sampling and characterization to better understand cell differentiation pathways and off‑target populations throughout manufacturing
• Addressing the challenges of monitoring a “living drug” by identifying meaningful process parameters (e.g. metabolites, cell viability, yield) and correlating them to critical quality attributes and product performance
• Using in‑process data to enhance insight into differentiation dynamics, impurity clearance, and process variability – laying the foundation for improved control, reduced risk, and stronger regulatory confidence

This interactive break offers a dedicated space to connect with peers and explore cutting‑edge work in process monitoring, manufacturing intelligence, and advanced analytics. Browse poster presentations showcasing real‑world applications across development, tech transfer, and GMP manufacturing. Engage directly with presenters to discuss practical challenges, lessons learned, and innovative approaches to implementing PAT, real‑time monitoring, and data‑driven decision‑making.

Whether you’re looking for ideas to enhance your own strategies or to share your work with a focused community of experts, this session provides a valuable opportunity to exchange insights and spark collaboration. For more information or to share your work, please email info@hansonwade.com

• Leveraging MSAT‑led modelling and data science to support tech transfer, scale‑up/ scale‑down, and real‑time monitoring in commercial manufacturing
• Applying advanced modeling approaches to forecast process outcomes and CQA performance before full data is available
• Supporting tighter control of critical quality attributes and yield by equipping manufacturing teams with predictive insights to act ahead of potential deviations

This is a chance to reflect on the learnings from the day and discuss with the room what actionable takeaways you want to bring to your organization. Topics include:

• Demonstrating ROI & Commercial Impact Across Process Monitoring to Enhance Implementation
• Enhancing Adoption & Implementation of Tools in the Real World
• Empowering Data Management Systems to Make the Right Manufacturing Decisions Faster
• Leveraging GMP-Compliant AI & Data in Process Monitoring